IPMed

EU Parliament Delegation in Taiwan to Assist with WHA Bid; Executive Board 124th Session

2009-01-26T10:45:00.011Z

A delegation of Members of the European Parliament (MEP) is currently in Taiwan, completing a visit to meet with Taiwan's health authorities. The visit is in support of the country's bid to join the World Health Organization (WHO) at its supreme-decision making body of member states, the World Health Assembly (WHA) in May.

Horst Posdorf (Committee on Development and leader of the delegation), Eugenijus Maldeikis (Lithuanian MEP Union for Europe of the Nations (UEN) and member of the Committee on Industry, Research and Energy) and Metin Kazak (Bulgarian deputy of Alliance of Liberals and Democrats for Europe (ALDE) are meeting with authorities in support of Taiwan's efforts to join the WHA at the 62nd annual conference in May. During their 5 day visit, the delegation will meet with various health authorities. Taiwan News reports meetings with "Legislative Yuan Deputy Speaker Tseng Yung-chuan; Deputy Chairman of the Cabinet-level Mainland Affairs Council Chao Chien-min; Deputy Minister of Economic Affairs Sheng-chung Lin; ruling Kuomintang Deputy Chairman Wu Den-yih; and opposition Democratic Progressive Party Chairwoman Tsai Ing-wen. Delegates will also visit the Government Information Office, the Taiwan External Trade Development Council, and the Ministry of Foreign Affairs' International Cooperation and Development Fund. The trio will be invited to a banquet by Deputy Minister of Foreign Affairs David Y.L. Lin." Legislative Yuan Speaker, Wang Jin-pyng, will also address Parliament in plenary in Strasbourg next month.

A parliamentary source was reported in the morning bulletin of The Parliament as stating, "The delegation will try to gain a better understanding of Taiwan's political and economic development over the past few years." The bid is said to be supported by several senior MEPs, including the group leader of ALDE, Graham Watson, and Edward McMillan-Scott, British Conservative and vice president of parliament.

The Executive Board of the WHO is currently in its 124th Session in Geneva and will complete its agenda tomorrow. The Executive Board's considerations have included the Draf t WHO Strategy on Research for Health. The Draft Strategy refers to Resolution 61.21 (the Global Strategy and Plan of Action adopted by the last WHA), to which the Draft Strategy must have regard. 61.21 The Draft Strategy notes the obstacles to its translation goal (to strengthen links between research, policy and practice) posed by inequities in access. It explicitly identifies restrictions on reuse (through copyright and intellectual property) as contributing to this problem, particularly in its interplay with competition issues (including interoperability of information systems).

The A2K discussion list disseminated the US intervention on the Draft Strategy, which raised concerns regarding the "portrayal of copyright and intellectual property issues" in the Draft Strategy. The intervention maintained "We do not see them as contributing to 'the global inequality of access to health data, tools, materials, and literature'." The US intervention emphasised intellectual property rights as a mechanism by which to gain access to materials rather than an obstacle.

In its advisory role to the WHA, the Executive Board is also due to meet in its 125th Session immediately after the WHA 62nd Session in May.

US Approves Embryonic Stem Cell Research Trials

2009-01-25T19:47:00.010Z

The US regulator, the Food and Drug Administration (FDA), has approved the first trials in humans of embryonic stem cell research.

The approval came just 2 days after the inauguration of President Barack Obama, causing some to speculate that the new administration is set to remove some of the financial obstacles faced by research in this area. Soon after taking office for his second term in 2001, President George W Bush announced, 9th August, a restriction on federal funding for embryonic stem-cell research. Although not a ban of the research per se, the lack of federal funding was variously described as leading to more or less the same result. In 2oo6, President Bush vetoed H.R 810 / S 471 to amend the Public Health Service Act to provide for human embryonic stem cell research. President Barack Obama had been expected to reverse the ban soon after taking office this year.

The approval authorises the US biotech company, Geron, to commence clinical trials of GRNOPC1 in patients with severe spinal cord injuries. Upon the completion of these trials, the company will be required to demonstrate efficacy before marketing authorisation can be granted. The Financial Times reports that such commercial availability could be achieved within 3 years. In a news release, Geron describes the approval as "A new chapter in medical therapeutics — one that reaches beyond pills to a new level of healing."

The Christopher and Dana Reeve Foundation responded to the announcement in a news release welcoming the decision. The actor Christopher Reeve sustained serious spinal cord injuries in a horse-riding accident, 27th May 1995. Shortly before his death, 10 October 2004, Reeve spoke on the US stem cell debate saying, "No obstacle should stand in the way of responsible investigation."

Constitution for the NHS

2009-01-24T18:41:00.009Z

The publication of a new Constitution for the National Health Service (NHS) has been described as heralding a "new era of patient rights." Prime Minister, Gordon Brown, stated "This is a great day for the NHS, it is a great day for Britain. I am very pleased to be here on this historic occasion." The Constitution affirms the emphasis on patient choice and patient rights advocated in the NHS and is the result of an investment of £1M and consultation with NHS staff and patients.

The result clarifies the "patient choice" policies of the NHS in the rights and responsibilities of patients as well as health care workers and institutions. The Constitution establishes that patients may choose a GP practice and cannot be refused by that practice without reasonable grounds.

Health Secretary, Alan Johnson (pictured at right), explained that this emphasis on patient choice is the basis for a greater cooperation between patients and health care professionals: "This is a momentous point in the history of the NHS. Following on from Lord Darzi's Next Stage Review [High Quality Health Care For All], the launch of the NHS Constitution shows how its founding principles still endure today and have resonance for staff, patients and public alike." Lord Darzi's Review was published last June and maintained the need for a constitution to declare and protect the principles and values of the NHS in England.

The Health Secretary stated further that the new Constitution "will ensure that we protect the NHS for generations to come ... and will form the basis of a new relationship between staff and patients - a relationship based on partnership, respect and shared commitment where everyone knows what they can expect from the NHS and what is expected from them." Part of that relationship and cooperation means greater emphasis on patient information as to alternative treatments so that they are able to choose between options, rather than relying upon "doctor knows best."

Of the 25 rights, rights to access approved drugs, information and treatment are also set out in the constitution. Following controversies last year associated with drug pricing and the capacity to provide access to NHS patients, it is of interest that under the Health Bill 2009, introduced into Parliament 15 January 2009 (if enacted), it would become a statutory duty to account for these rights when making a decision (Clause 2).

However, in addition to the staffing and funding implications, many are unconvinced that having regard to these rights will make a lot of difference in practice. Dr Hamish Meldrum (Chair of the British Medical Association (BMA)) suggest it is simply "a feel-good document." The Patients Association, issued a statement in which it described the document as full of simply "optimistic pledges" without any incentive to deliver. Director of the Patients Association, Katherine Murphy (pictured at right), stated "We do not expect this document to make any difference to the care patients are receiving ... Patients need to know what the duty in the new Health Bill, requiring NHS organisations to ‘have regard to the NHS Constitution’, will really mean in practice. For the NHS Constitution to be effective, Trusts need to do more than ‘have regard’ to it. The time for NHS management to manage as if their jobs depended on it is long overdue. The time for words like safety, quality, choice and, in this case, Constitution to have the meaning they have elsewhere in life is also long overdue."

Access to Information or Promotion! Proposed EU Information Laws on Prescription Drugs

2008-10-14T18:42:00.012+01:00

A proposed EU law, being considered by the Commission, to facilitate information on prescription-based medicine has been welcomed by the pharmaceutical sector but criticised by pharmacists, civil society and others as proxy advertising.

The EU originally launched a public consultation on its legal proposal on information for patients in February 2008. Responses and outcomes were subsequently analysed as mixed. The industry welcomed the measures, describing the proposal for non-promotional information as integral to achieving a healthier European society. The European Federation of Pharmaceutical Industries and Associations (EFPIA) in particular has supported the proposals as part of an overall policy of "access." But the developments that ultimately led to the publication of the consultation largely originated in strategic discussions for the pharmaceutical sector.

In 2000, the Council of Ministers issued its Conclusions on Medical Products and Public Health, which identified certain issues and factors relevant to the achievement of public health goals - both in terms of the public and in terms of industry advancement and European competitiveness in the pharmaceutical sector. This led to the Commission's establishment of a High Level Group on Innovation and the Provision of Medicines ("G10 Medicines") to examine issues for the pharmaceutical sector.

In May 2002, the G10 Group reported 14 recommendations, which included the recommendation for the creation of a forum dedicated to the pharmaceutical sector. In 2003, the Commission published a communication on a stronger European-based pharmaceutical industry for the benefit of the patient, a call to action in response to the report of the G10 Group. Included in that communication was the key action for the Commission to "explore, with stakeholders, a range of approaches to provide a realistic and practical framework for the provision of information on prescription and non-prescription medicines." And in 2005, the Pharmaceutical Forum was established to progress work according to the three key themes, which are coordinated within special working groups:

information to patients on pharmaceuticals

pricing policy

relative effectiveness.

A European Parliament conference Tuesday heard cautions against the proposed law simply resulting in proxy advertising for the pharmaceutical industry. Secretary General of the Pharmaceutical Group of the European Union (PGEU), John Chave (pictured at right), is not convinced of the need for the legislation: "If, however, the laws are to be changed, it is of fundamental importance that public confidence in the integrity of the information provided is maintained. The pushing of information by the industry should never be a proxy form of promotion or advertising. The sole justification for change can only be to help patients and not to grant more commercial freedom to the pharmaceutical industry." In its submission to the public consultation, the PGEU identified problems with self-regulation in the industry, among other concerns.

Arguably, a reliance upon receiving information from the industry (and indeed the proprietors themselves), where that information still requires intepretation and application by the individual patient in those circumstances, is not conducive to the genuine accessibility of health information. Rather, patient information and autonomy with respect to medicines should issue from contact with health care professionals and access to adequate and effective primary health care, including pharmacists and physicians. The information is therefore available as to alternatives, rather than tied to the product.

Pharmaceutical Firms Pledge HIV/AIDS R&D for Resource-Poor

2008-10-13T22:40:00.005+01:00

Last week, after meeting with pharmaceutical executives from 17 different firms, UN Secretary-General Ban Ki-moon announced that major pharmaceutical firms were pledging to invest more in research and development on HIV/AIDS treatments and diagnostic procedures for poorer and resource-limited regions, as well as prevention and vaccines.

Despite research developments and new products, inequities in access to medicines continue: "We noted that despite the gains, the epidemic continues to outstrip our best efforts. Only one-third of those who need antiretroviral treatment in low-and middle-income countries are getting it." The Millenium Development Goal 6 is specifically concerned with achieving universal access to HIV/AIDS medicine by 2010 and the halt of the spread of the disease by 2015.

The firms that met with the UN Secretary-General included Abbott Laboraties, which has been in the press for its controversial pricing of Norvir following the marketing of its newer drug, Kaletra.

Access to information is also an important factor in achieving these goals, and China is recognising the significance of data-sharing in disease control. An international team of researchers investigating HIV infections in southern China has been granted full access to government medical data, as reported in Nature. This transparency is advocated as part of China's overall strategy to reach its goal of limiting total infections to 1.5million by 2010.

The Wellcome Trust Book Prize

2008-10-12T19:40:00.004+01:00

The Wellcome Trust has just launched a book prize at the Times Cheltenham Literature Festival.

The £25,000 Wellcome Trust Book Prize (making it one of the richest literary awards) will go to the author of an outstanding literary work engaging with perspectives on medicine, health and illness.

Medicine has always been an important literary vehicle, from Bram Stoker's Dracula to Gabriel Garcia Marquez's Love in the Time of Cholera, and this new prize will reward these literary interrogations of attitudes to sickness, health and the medical profession.

The panel, chaired by comedian and former psychiatric nurse, Jo Brand (pictured at right), will consider books published between now and September 2009. Speaking to the Guardian, Jo Brand said, "We are looking for books like One Flew over the Cuckoo's Nest [one of Brand's personal favourites], that have illness at the centre of the story."

Jo Brand is joined on the panel by Quentin Cooper (BBC science journalist), Brian Hurwitz (D'Oyly Carte Professor of Medicine and the Arts, Kings College London), Gwyneth Lewis (Welsh author and poet) and Raymond Tallis (former Professor of Geriatric Medicine at the University of Manchester and Consultant Physician, now full-time writer and Visiting Professor to St George's Hospital Medical School, University of London).

The shortlists of 6 works will be announced at next year's Times Cheltenham Literary Festival in October.

SA Medicines Bill Approved Amid Widespread Condemnation

2008-08-28T22:03:00.005+01:00

The controversial South African Medicines and Related Substances Amendment Bill 2008 was approved by the Parliamentary Portfolio Committee on Health this week.

Although the Bill still has to go before the full Parliament in September, it is expected to be passed into law.

The amendment establishes a new State regulatory authority, the South African Health Products Regulatory Authority, replacing the Medicines Control Council (MCC). The MCC is currently the national competent authority for the approval of new medicines to be marketed in South Africa.

The controversial aspects of the new law are its granting of ultimate decision-making authority to the Minister, its changes to the appeals process and ultimate authority on marketing decisions.

Under the new section 15 "Certification and registration of products", the Minister can choose to refuse approval of a new drug for marketing, after it has passed clinical trials and has been cleared by the Regulatory Authority. The Minister can refuse to register a product if it is considered contrary to the "public interest" - in this decision the Minister is to take account of:

public health interests;
economic interests in relation to health policies;
strategic interests in relation to health policies;
the need and desirability for such produch; and
generally whether the public would be best served by such registration.

The amendment to section 24 and new section 24A establishes a new appeals process which allows opposition on any grounds (not just scientific) to the decision of the Regulatory Authority or the Director-General. But it appears that the amendments do not provide for appeal against the decision of the Minister.

The Bill has been strenuously opposed by pharmaceutical companies and patient groups alike. It is described as replacing the role of the regulatory authority with an appeals process and a Ministerial decision. Critics have suggested that this leaves the process vulnerable to abuse, mis-use by competitors and interference from policy positions.

In particular, South Africa's track record on the approval of anti-retrovirals is very worrying if this system goes ahead. At the XVI International AIDS Conference 2006, the UN Special Envoy criticised South Africa's approach to prevention and treatment, and others called for the resignation of the Health Minister, Dr Manto Tshabalala-Msimang. The Health Minister had insisted that the South African display include garlic, lemons and African potatoes (pictured at right). Soon after the international meeting and with ongoing public pressure, South Africa appeared to respond with a change in policy but with the removal last year of more progressive Deputy Health Minister, Nozizwe Madlala-Routledge. AIDS activists called the sacking "a dreadful error of judgment." Earlier this month the Health Minister declined to attend this year's XVII International AIDS Conference in Mexico City.

Dubbed as Dr Beetroot, Dr Garlic and worse, there is a dedicated "SackManto" website and in 2007 scientists wrote a joint letter of protest to President Mbeki. But he has continued to give the Health Minister's position his full support.

Treatment Action Campaign (TAC) former chairman, Zackie Achmat, has stated that the new structure will compromise the independence of the Regulatory Authority and "will leave it vulnerable to political interference." TAC has opposed the Bill and has declared it will take action to prevent the Bill becoming law. Many groups are said to be prepared to take legal action if the Bill is passed into law in September in what is described as one of the most important pieces of health legislation in South Africa in recent years.

Thailand - Compulsory Licensing Will Continue

2008-08-20T23:08:00.006+01:00

The Public Health Minister, Chavarat Charnvirakul (pictured right), has declared that compulsory licensing of essential medicines will continue in Thailand, despite ongoing pressure from international pharmaceutical companies.

The announcement comes after months of speculation as to whether the health policy would continue, with the election of a new government in April this year. And it follows reports of lobbying of the government by Sanofi-Aventis to purchase its product.

Wichai Chokewiwat, Government Pharmaceutical Organisation (GPO) chairman, is reported as stating that Sanofi had offered to compensate the GPO by selling its products at a discount in Thailand.

Meanwhile, The Nation has reported today that a group of 500 HIV/AIDS activists and patients have challenged Sanofi-Aventis to take its claims to the Central Administrative Court. The challenge is to put in a public forum claims made in a confidential letter to the Commerce Minister requesting a review of the enforcement of compulsory licensing of docetaxel (for which a licence was issued in January this year).

The president of the Thai NGO Coalition on AIDS, Supattra Nakapiew, is reported as stating "We want Sanofi Aventis to file a lawsuit with the Central Administrative Court because we want this case to be a test for the enforcement of compulsory licensing of life-saving drugs in the future."

Before the end of this month, a joint committee meeting of senior officials from the Public Health Ministry, Commerce Ministry and Foreign Ministry together with other interested parties (including civil society organisations and the Pharmaceutical Research and Manufacturers of America, PhRMA) will decide on solutions to access to essential medicines in Thailand and the best means by which these can be delivered.

Bird Flu Vaccine Patent

2008-08-20T11:55:00.007+01:00

Some interesting or disturbing (depending on your perspective) news to report today as it appears that the US Government has applied for an international patent in respect of a vaccine for the treatment of influenza and in particular for the treatment of bird flu (H5N1).

The patent application was first filed with the United States Patent Office (USPTO) on February 16, 2006 as application number 60/774,923. Exactly a year later the same application was filed via the Patent Cooperation Treaty (PCT). The PCT application is numbered PCT/US2007/004506 with a corresponding publication number of WO/2007/100584.

The applicants are cited as the Government of the United States of America, as represented by the Secretary, Department of Health and Human Services -National Institutes of Health,, Office of Technology Transfer, 6011 Executive Blvd., Suite 325, Rockvillle, Maryland 20852-3804 (US) and the Government of the United States of America, as represented by the Secretary, Department of Health and Human Services - Centers for Disease Control and Prevention, 4770 Biford Hwy (K79), Atlanta, Georgia 30333 (US).

In the description of the application the applicant notes ‘The significant public health impact of Influenza A and B virus infections is compounded by the threat of emerging virus strains. Concerns exist that avian influenza virus (H5N1), endemic in poultry in Southeast Asia, may trigger a pandemic in humans should the virus evolve to spread from human-to-human’.

It goes on to state that the ‘invention provides a vaccine strategy for controlling influenza epidemics, including avian flu, should it cross over to humans, the 1918 strain of flu, and seasonal flu strains. In addition, the invention is designed to lead to a combination vaccine to provide a broadly protective vaccine'.

Whilst acknowledging the existence and availability of other patents for the treatment of bird flu, citing those owned by Sanofi Pasteur, Inc. and Chiron Corporation as examples, the applicant nevertheless proffered that there was still a concern that the production by these companies would not be sufficient to meet demands were there to be a worldwide pandemic. The applicants relied on a 2004 World Health Organization (WHO) which highlighted the need for a ‘new broad-spectrum influenza vaccine’ to treat with multiple influenza strains.

What is controversial about this particular patent application is that the new vaccine incorporates one to four genes from a H5N1 strain which was isolated from an Indonesian victim of bird flu in 2005. It goes further by also incorporates genes from flu strains in Thailand, Hong Kong and South Korea. It is worth noting that the strain that contains the genes was transferred to the WHO Global Influenza Surveillance Network (GISN) by Indonesia for characterization for public health purposes.

This is a troubling development as one of the applicants, the Centers for Disease Control (CDC) is a WHO Collaborating Centre for influenza and virus studies. The mandate of Collaborating Centres is to receive influenza viruses from donor country for public health characterization purposes. The patent application raises specific questions about the US CDC, which is a WHO Collaborating Centre for influenza virus studies. The WHO Collaborating Centres receive influenza viruses from donor countries for public health characterization purposes, and not for the purposes of making proprietary claims. The GISN’s effectiveness rests on the prompt sharing of and access to viruses from all donors. However, one wonders how many donor countries will wish to continue to share influenza viruses for research and vaccine development if it is that Governments who operate Collaborating Centres are minded to make proprietary claims over the materials which they have received as a result of the GISN system. Obviously this patent application built on the back of the GISN system of virus sharing will call into question the entire system and may very well undermine its effectiveness.

As for the application itself there are far reaching implications for developing countries especially when one considers that this particular patent application for a bird flu vaccine designates over 100 countries states, including most Latin American, African, and Asian countries.
What can be done? What of the rights of the Indonesian Government which supplied the strain from which the gene has been extracted? Does the human victim from whom the gene was extracted have a proprietary right to his gene?

It seems that it is these occurrences which strengthen the call for a reform of patent laws. It would seem patently unfair (pardon the pun) for the US Government to be able to assert ownership of a gene that was provided in good faith for public health purposes and to gain a potential financial windfall by acquiring a patent for commercial exploitation.

The developments in this one will be worth following.

Rising Drug Prices - The Real Devil in the Detail

2008-08-11T11:37:00.005+01:00

Decisions not to supply certain drugs on national health schemes may be an inevitable consequence of a wider problem of rising prices for a growing number of patented medicines. The recent NICE preliminary decision to advise the UK National Health Service (NHS) against several high-priced treatments for advanced renal cell carcinoma was largely attributed to the high cost of these medicines.

In an article last week in USA Today it is suggested that a small number of prescription brand-name medicines in the US, still protected by patents, are being raised in price by 100-1000%. Overall, price rises last year were around 7.4% on average for brand-name drugs in the US.

While patents potentially preserve prices against oversight by conventional competition, pressure is coming from elsewhere. In December 2003, Abbott Laboratories Inc raised the price of the HIV/AIDS drug, Norvir (ritonavir), by just over 400% (from USD205.74 to USD 1028.71 for 120 capsules). In May of 2004, the US-based civil society coalition, Prescription Access Litigation (PAL) filed a class action lawsuit in Illinois state court against Abbott and in October 2004 filed a federal class action suit in the US District Court in California.

Only last week did Abbott agree to settle the lawsuit (the decision awaits approval and the final amount will depend upon the decisions of the 9th US Circuit Court of Appeals regarding the antitrust questions in the case).

But Abbott faces potentially larger damages in the lawsuit filed in October 2007 by pharmacies and wholesalers, and joined by competitor GSK. The case goes before the US District Court Judge Claudia Wilken next week.

The problem is a kind of pharmaceutical BlackBerry issue. Norvir, which received FDA approval in 1996, is a Protease Inhibitor (PI) and is an essential component in highly active anti-retroviral treatment (HAART) used to treat HIV/AIDS. Although initially marketed as a standalone PI, Norvir subsequently became more commonly used in low doses as a booster in HAART.

Abbott then introduced Kaletra around 4 years later as a fixed-dosed combination product and the only such product to include Norvir/ritonavir. The wholesale price of Norvir was then raised in 2003, but not that of Kaletra (despite containing ritonavir). Raising the price of Norvir effectively raised the price required to access the 8 out of 9 competitors' drugs that rely upon Norvir as the booster in HAART. Kaletra thus became a cheaper alternative, but not necessarily a medically-appropriate one for all candidates. The Kaletra patent does not expire until 2016.

According to reports in the San Jose Mercury News, San Franciso, internal memos at the time warned that if the price of Norvir was raised, Abbott would come off as the "big, bad, greedy pharmaceutical company."

As much as I wouldn't want to give up my BlackBerry, it seems the Norvir stranglehold puts quite a bit more at stake.

NICE Won - High Prices and New Deals

2008-08-09T00:55:00.010+01:00

This week in the UK the National Institute for Health and Clinical Excellence (NICE), which advises the National Health Service (NHS), proposed against further use of four treatments for advanced renal cell carcinoma that has spread from the primary tumour. A final decision on the proposal is not expected from the NHS until January.

NICE applies criteria for "cost-effectiveness" which the four drugs - Avastin (bevacizumab) owned by Genetech/Roche; Nexavar (sorafenib) owned by Bayer; Sutent (sunitinib) owned by Pfizer; and Torisel (temsirolimus) owned by Wyeth - did not fulfil.

The decision has been widely criticised as the drugs present the very few options for patients with this advanced renal cancer. Charities, including Cancer Research UK, have condemned the decision. And practitioners have raised concerns regarding the effectiveness of interferon as the only treatment option remaining. Professor John Wagstaff of the South Wales Cancer Institute told the Independent that there would be no point in referring patients as around 75% gain no real benefit from interferon. James Whale (pictured), broadcaster, was diagnosed with renal cancer in 2000 and told the Telegraph "If final guidance remains as it currently stands it will certainly mean an early death sentence for many."

However Professor Peter Littlejohns, Clinical and Public Health Director at NICE, has defended the decision in a BBC report, maintaining that providing these treatments would mean forgoing treatments for other patients in other areas.

GSK, on the other hand, is said to be working to alleviate pricing obstacles to NICE approval for the drug Tyverb, used in the treatment of breast cancer. In this case as well, NICE refused to adopt the new drug despite GSK's attempts to negotiate a "risk-sharing" arrangement with the Department of Health (DH) where the DH is charged only for the proportion of patients estimated to have received significant benefits from the treatment. The UK-based pharmaceutical company is now working towards a "price-volume" deal with the DH in order to resolve the concerns with cost.

The "price-volume" proposal presents an innovation in pricing where a cap is introduced on the total cost of the medicine to the NHS, regardless of the number of patients being treated (whether it is higher or lower than the cap). The fixed price will cover the cost of the drug for several thousand patients. This price would apply if fewer patients were recruited. The NHS will therefore benefit if it identifies a higher number of patients to receive the drug.

The Financial Times describes the GSK proposal as "pioneering" at a time when pharmaceutical companies are coming under increased pressure to address pricing obstacles to adequate delivery of healthcare and patented medicines. The proposal innovates upon a conventional business model to the company's benefit of greater overall sales and to the benefit of patients in greater access to new medicines.

But this might be a bridge too far for some and a deal too late for many.

Innovations in Access - Priority, Pools and Policy

2008-08-06T17:51:00.009+01:00

Priority Review Voucher

Amendments to the US Food, Drug and Cosmetic Act Administration (FDA) come into effect next month, with the issue of the first priority review vouchers expected. The amendments, introducing these vouchers, were proposed to provide new incentives for research into neglected tropical diseases. The bill was introduced by Senators Sam Brownback (Republican, Kansas) and Sherrod Brown (Democrat, Ohio) in 2007 and signed by President Bush in September that year.

The Food and Drug Administration Amendments Act (HR 3580) amended Subchapter A of Chapter V of the Food, Drug and Cosmetic Act (21 USC 351, et seq) inserting Section 524 and introducing a system of priority review vouchers for companies seeking to register drugs and vaccines for neglected tropical diseases.

The effect of the voucher is to gain fast-track approval for other drugs that company may seek to register in the future, potentially reducing registration times by almost a year. Following Section 524(b)(3)(B), the first voucher may be expected 27 September, ie, one year on from the date of enactment (Presidential assent).

Regulatory delays are frequently cited by pharmaceutical companies as costly inefficiencies, thereby making a system to mitigate these delays very financially attractive to the industry. However, concerns have been raised. Although the vouchers ideally become important and valuable commodities to facilitate partnerships and to sell onto other companies and thus finance clinical trials for partnerships researching in these neglected diseases (amendments in June provided for the transferability of the vouchers), some have cautioned that the system will not necessarily drive new research. Rather, in some cases they will simply entice companies to seek US registration of drugs already on the market in other countries, with the benefit to the company of a very bankable voucher without the social benefit of new research. Others even doubt the value of the voucher, suggesting that the era of the blockbuster drug is over.

The research qualifying for vouchers might also be limited, with vouchers being available only for registration of drugs containing active ingredients not previously approved. This has been noted as a potentially serious limitation of the scheme, with no incentive for research into new uses for existing formulations and new combination therapies.

Patent Pools

Another significant initiative in access also in the press is that of patent pools. Following the briefing on the UNITAID Patent Pool at the 17th International AIDS Conference, currently underway in Mexico City, James Love explains the major features of the UNITAID patent pool:

the pool is created as a voluntary mechanism;

patent owners have the opportunity to identify the field of use for patents licensed to the pool;

patent owners may exclude countries to which the licence will not apply.

Patent pools are not new, one of the first dating back to the 19th century when a group of sewing machine competitors (including Singer) decided in 1856 to cross-licence rather than decimate their profits by suing each other. This kind of business model persists today and is arguably of very significant application when it comes to medicines.

The Universities Allied for Essential Medicines (UAEM) this week endorsed the scheme: "UNITAID steps forward as a visionary leader in the global fight against diseases affecting the poor." UAEM has called upon universities to endorse the scheme and to contribute to the scheme through consultation with present licensees and through reservations on future licences.

Generics remain instrumental in facilitating access to treatment in developing countries, and at a time when generics are credited as dominating the US Global AIDS initiative, concerns have been raised regarding the scope of the proposed Anti-Counterfeiting Trade Agreement (ACTA). In comments on the proposed agreement, the Generic Pharmaceutical Association (GPhA) urged the US Trade Representative (USTR) "not to allow the rising momentum behind a global anti-counterfeiting strategy to be diffused by deviating into expanded IP protection and enforcement with respect to patents and data exclusivity." Today, a sign-on letter was released by Essential Action and others, urging negotiators to publish the draft text together with pre-draft papers and criticising the ongoing secrecy of the negotiations.

Comments Invited on UK Policy in Access to Medicines

Meanwhile, research is currently taking place into UK Government policies on access to medicines, with consultation with industry, government departments and other stakeholders due to take place in the first half of September. The draft report, being prepared by Emma Back and Samia Saad, will be published in early October on which there will be further consultation later that month. The report will ultimately inform the subsequent edition of the UK's Good Practice Framework, to be managed by the Department for International Development (DFID) in conjunction with Business Enterprise and Regulatory Reform (BERR), Department of Health (DH) and the Intellectual Property Office (IPO).

Comments on key issues to consider and address are invited by the consultants. These should be provided in no more than two pages and no later than 22 August 2008. These may be sent directly to Emma Back (emma.back1@hotmail.com) and Samia Saad (samiasaad@gmail.com).

Traditional Healers Trained in HIV Health Care

2008-08-05T15:13:00.004+01:00

The fight against HIV/AIDS in Haiti is being strengthened by a collaboration between medical practitioners and traditional voodoo healers.

Recognising the important relationship between people living in rural Haiti and traditional healers, training in identifying symptoms and advising on treatment is now being provided to traditional healers.

Since most people would consult a traditional voodoo healers for advice, Promoteurs Objectif Zéro Sida (POZ) in Haiti have launched projects to bridge the cultural and technical divide between traditional medical knowledge and western medicine. POZ also provides referral cards to the 30 healers trained in treatment and prevention advice, who sent 360 patients to the conventional HIV testing centre and clinic. (At left: Aurore Julien Brazier, community nurse at POZ's main health clinic in Montrouis)

In recognition of its work, POZ was recently awarded the UNAIDS/UNDP Red Ribbon A ward, which is being presented at the International AIDS Conference in Mexico City this week.

POZ is also a partner of Alliance which works towards community action to fight AIDS in developing countries.

WHO Bulletin - Special Issue on Ethics and Public Health

2008-08-04T12:11:00.003+01:00

The World Health Organization (WHO) has just published the August issue of the WHO Bulletin.

This month's issue is dedicated to ethics and public health, including a contribution on the ethics of drug donations from Christina P Pinheiro, Department of Hygiene and Epidemiology, University of Porto Medical School, Porto, Portugal.

Pinheiro notes the lack of international regulation on drug donation procedures and the opportunity therefore for exploitation. While the WHO has published interagency guidelines for drug donation, these are merely guidelines, not international regulations.

The large number of agencies involved in drug donations leads to undue complexity and inefficiency in the process, including unfortunate waste. For instance, in a 2006 study of Pharmaciens Sans Frontieres Comite International, it was noted that all major donations of pharmaceuticals do not meet recipients' needs.

Pinheiro criticises the origins of donations for their inappropriateness - including industry surplus, free samples and returns to pharmacies for disposal. Further problems are raised by the state in which drugs are delivered, including expired drugs and labelling in languages unknown by the local health workers. And drugs which are unusable become the burden of the recipient country, now responsible for their disposal as hazardous waste. In many ways, "free" donations can become quite costly to the recipient countries, greatly undermining the value of this procedure in many cases.

The ethical issues are clear, with an acceptance that something is better than nothing, rather than demanding the best medicines. As Pinheiro states, there is "a disturbing division between the rights and worth of different populations."

Geneva Workshop - Health and Patent Flexibilities

2007-12-07T16:06:00.000Z

The WTO Workshop on TRIPS and Public Health in Geneva earlier this month included participation from 19 officials of developing countries.

Part of the WTO's technical cooperation and capacity-building activities, this workshop was particularly interesting for its emphais on the use of flexibilities in TRIPS for public health purposes.

In particular, the workshop delivered training on the August 2003 and December 2005 decisions, the so-called "paragraph 6 system" of compulsory licensing.

Participants came from including Argentina, Brazil, Cuba, the Gambia, Hong Kong China, India, Indonesia, Iran, Jamaica, Malaysia, Mali, Namibia, Peru, Philippines, Saudi Arabia, Singapore, Turkey, Vietnam and Zambia.

Indonesia, a participant at the workshop, has been at the forefront of recent initiatives in public health. The country is maintaining its stance against participation in the World Health Organisation (WHO) virus-sharing programme, refusing to share bird flu virus samples unless material transfer agreements can place conditions on the subsequent vaccine, including conditions on commercial use, pricing and the creation of intellectual property rights. The New Scientist reports that Jakarta has shared just two specimens this year, both from the tourist resort of Bali.

Public health has been on the agenda for a lot of the WTO's cooperation events recently, including a workshop in the Asia-Pacific in July this year.

Canada - First Notification of Compulsory Licence to Export

2007-10-07T20:43:00.000+01:00

On Thursday, Canada became the first country to notify the TRIPS Council of the World Trade Organization (WTO) under Paragraph 2(c) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration of the TRIPS Agreement and Public Health.

The notification follows the earlier notification to import made by Rwanda, 17 July, under paragraph 2(a). This earlier notification informed the WTO of the intention to import 260 000 packs of the fixed-dosed combination treatment for HIV-AIDS, TriAvir. Canada's notification to export the medicine to Rwanda is required under the Decision of 30 August 2003 and, according to the WTO news item, "completes the circle."

Canada's notification under paragraph 2(c) fulfils the requirements under that provision to provide to the TRIPS Council relevant infromation on the compulsory licence. As such, the notification announces the authorisation for the medicine to be produced and exported to Rwanda, the conditions governing the compulsory licence and the medicine covered by the licence. Also required is the website of the company licensed to produce the generic version where posts on quantities and other relevant information are to be published before export occurs.

Future notifications of exports will be published on the WTO's dedicated page. Meanwhile, the UK Intellectual Property Office (IPO) has launched its informal consultation on the proposed changes to the UK Patents Act 1977 to give effect to the Communities' implementation of the Decision on Paragraph 6 on compulsory licences and supplementary protection certificates - Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems (Compulsory Licences Regulation). The deadline for responses is 31 October.

WTO Paragraph 6 System Used for First Time by Rwanda

2007-07-20T16:15:00.000+01:00

[Apologies for cross-posting from my post on IPKat]

Yesterday Rwanda became the first country to notify the World Trade Organisation (WTO) under the 30 August 2003 decision.

The 30 August 2003 decision implemented Paragraph 6 of the Doha Declaration on TRIPS and Public Health. The decision addressed the public health needs of countries with no capacity to manufacture under a compulsory licence. The decision created a mechanism for such countries to import cheaper generics made under compulsory licensing elsewhere - the "Paragraph 6 System" or "Paragraph 6 Solution". A permanent amendment to TRIPS was agreed 6 December 2005 in Article 31 bis, but as yet only 7 countries have accepted the amendment (or just 4.7% of the membership): United States, Switzerland, El Salvador, Republic of Korea, Norway, India and the Philippines.

Rwanda has notified the WTO of the proposed importation of HIV/AIDS medicine manufactured in Canada in yesterday's submission IP/N/9/RWA/1. Under Paragraph 2(a), the details of proposed importation by an eligible country are to be notified:
"Based on Rwanda's present evaluation of its public health needs, we expect to import during the next two years 260,000 packs of TriAvir, a fixed-dose combination of Zidovudine, Lamivudine and Nevirapine manufactured in Canada by Apotex, Inc. However, because it is not possible to predict with certainty the extent of the country's public health needs, we reserve the right to modify the foregoing estimate as necessary or appropriate."
However, as a least-developed country, Rwanda is not obliged to notify the desire to be an "eligible importing member" (Paragraph 1(b)).

The move has been described as "a bold step" amid suggestions that there is reluctance to utilise the flexibility of the Paragraph 6 System because of the restrictive and limited scope of the system.

More information is available on the WTO dedicated web page for the 30 August 2003 decision.

Novartis in India - An Update

2007-01-22T15:52:00.000Z

Novartis has been strongly criticised of late for its stance on production of generic versions of the leukaemia drug, Glivec, in India.

And now a petition has been launched by Medicins Sans Frontieres (MSF) to oppose the case and its potential to prevent the production of cheaper generic versions of the drug. In a press release, MSF International Council President, Dr Christophe Fournier, said, "This key source of medicines cannot be allowed to dry up."

In an earlier post, Novartis and the Challenge to Indian Patent Law, a background to the dispute was provided, together with a brief analysis of the claims.

Novartis had obtained exclusive marketing rights for 5 years for its cancer drug, Glivec (marketed as Gleevec in the US) , but because it was decided that the invention was not an invention, the exclusive marketing rights were withdrawn (new form of a known substance). Section 3(d) of the Indian Patents Act, which provides that "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance" will not be sufficiently inventive to warrant patentability. In other words, India is refusing to allow Swiss-type claims. And this is what Novartis wants to challenge, arguing that the law is not TRIPS compliant (Art 27(1)) and is unconstitutional. However, arguably TRIPS does not go as far as mandating the protection of new use, as discussed on IPMed previously. The case will be heard in Madras, 29 January.

To accompany the petition, MSF has also provided a backgrounder as well as a timeline for the case. Commentators have suggested that it may bring the same kind of pressure that saw the end to the South African litigation (which also involved Novartis among others) over HIV medicines in 2001.

Nigerian Law to Increase Local Production of Essential Medicines

2007-01-18T23:04:00.000Z

Nigeria is about to pass a law to allow local manufacturers to produce drugs to treat malaria and HIV/AIDS, two of Nigeria's most deadly diseases, according to a recent Reuters report.

According to the report, current production levels of necessary drug treatments are insufficient. At present, 14 companies in Nigeria are producing anti-retroviral (ARVs) for the treatment of HIV/AIDS and 8 are producing artemisinin-based combination therapies (ACTs) for the treatment of malaria. At the current levels of production, local companies are able to meet only 30% of the demand for malaria drugs, the rest being supplied by imports from China. Artemisinin (chemical formula at right) is extracted from Artemesia annua, mostly grown in China, but Chinese experts are advising programmes to grow the plant in Nigeria to meet higher production levels.

Ahmed Abdulkadir, special adviser to the Nigerian president, heads a taskforce to produce the essential medicines. In an interview with Reuters, during an anti-malaria conference in China, Abdulkadir said, "We will try to have the legislation passed. We've done all administrative work, it's at the final stage." He said further, "We will dismantle all those barriers so that our local industries are able to produce all of these drugs," explaining that local drug companies were preparing for increased production levels following the passage of the new law. As well as lessening the need for imports, Abdulkadir explains that the law would allow Nigeria to supply west and central Africa.

The World Health Organization (WHO) reports that between 300 and 500 million people contract malaria every year (map at right), with over a million fatalities (1 person every 30 seconds). The vast majority of these deaths (90%) occur in Africa, and most of the victims are children.

The WHO also reports that there were 4.3 million new infections of HIV/AIDS in 2006, with 2.8 million (68%) occurring in sub-Saharan Africa. In 2006, 2.9 million people died from AIDS related illnesses. In Nigeria, largely due to the HIV/AIDS epidemic, there has been a decrease in average life expectancy since 1991, to just 45/46 years (m/f).

Aldulkadir says that the WHO (of which Nigeria became a member in 1960) insists developing countries are given access to these essential medicines, "and that is what we are trying to make sure we have."

Ethical Pharmaceuticals

2007-01-14T17:36:00.000Z

Best wishes for 2007 from all of us at IPMed.

While we have been on a brief break, an important development in the campaign on access to medicines and needs-based research has been announced.

Professor Sunil Shaunak, Imperial College, and Professor Steve Brocchini, of the School of Pharmacy, University of London, have announced a new model of development and delivery, which they call "ethical pharmaceuticals." The researchers claim that by altering th e molecular structure of essential expensive drugs, such as the drug for Hepatitis C, they will be able to develop and market a cheaper alternative, without infringing the original patent or involving pharmaceutical firms. Indeed, pharmaceutical companies have been relying upon such "second generation" innovation to extend the life of a profitable drug before the expiration of patent protection.

With Dr Mire Zloh of the School of Pharmacy, the researchers haved worked to improve the availability and lower costs of existing treatment for Hepatitis C. Dr Zloh has identified the interdisciplinary approach in the research as one of the key factors towards paradigmatic shifts and important developments towards the model for ethical pharmaceuticals. The Schering-Plough drug used to treat Hepatitis C is called PEG-Intron (PEGylated interferon), which means it has a polyethylene glycol (PEG) side-chain on the interferon molecule. The researchers are still using a pegylated interferon but, from the reports, have discovered a way of locating an additional side-chain (second generation pegylation) elsewhere on the molecule. This achieves a more pure modified interferon much more cheaply, effectively creating a "new medicine" that is not protected by the patent. However, the industry has suggested that such drugs will still require safety trials and may potentially result in "a huge intellectual property issue."

PolyTherics (Imperial College spin-out company) was developed to build upon the work of Shaunak and Brocchini, and has teamed with the Indian company, Shantha Biotechnics. In this way, Shaunak and Brocchini will be able to develop and market the TheraPEG without selling publicly funded research to "big pharma" to take to market. Speaking to the BBC, Professor Shaunak said, "We in academic medicine can either choose to use our ideas to make large sums of money for small numbers of people, or to look outwards to the global community and make affordable medicines."

The McPatent

2006-12-02T11:20:00.000Z

The fast-food giant McDonalds has filed patent applications in Europe and the US that specify "the method and apparatus of making a sandwich". The apparatus boasts features that include “simultaneous toasting of a bread component” and inserting condiments into the sandwich with a “sandwich delivery tool.” The filling is placed in the ‘bread component’. For those of you who may be unfamiliar with the phenomenon of the sandwich, the patent application kindly explains that “Often the sandwich filling is the source of the name of the sandwich; for example, ham sandwich.”

The apparatus is designed to ensure the speedy production of sandwiches, in addition to uniformity of appearance. A diagram of the apparatus is available at: http://v3.espacenet.com/textdoc?DB=EPODOC&IDX=WO2006068865&QPN=WO2006068865

But before you cast your lunch aside for fear of a nasty encounter with a McDonalds patent attorney, the traditional, manual method of sandwich assembly is unlikely to be affected. Lawrence Smith-Higgins of the UK Patent Office said: "McDonald's or anyone else can't get retrospective exclusive rights to making a sandwich. They might have a novel device but it could be quite easy for someone to make a sandwich in a similar way without infringing their claims." McDonald's would not comment.

Access to Medicine Ongoing Challenge for Poor

2006-11-14T12:03:00.000Z

Oxfam has released today a Briefing Paper outlining how very little has changed to improve access to medicines since Doha. In the press release accompanying the publication, Oxfam says, "Poor people in developing countries are still being denied life-saving medicines five years after world leaders signed a formal trade declaration to put health before profits."

The Briefing Paper, entitled "Patents versus Patients: Five years after the Doha Declaration," maintains that trade rules continue to present a major barrier to genuine access to affordable medicines. The Paper describes patent protection as an ongoing obstacle to the delivery of cheaper generic versions to poor countries and calls for urgent action.

The Paper states "The Doha Declaration unequivocally recognises and clarifies that the TRIPS Agreement should not prevent WTO member countries from taking measures to protect public health," and "recognises the legitimate need of countries to take measures to reduce the price of medicines, such as using TRIPS safeguards." However, the "TRIPS-plus agenda" is seriously compromising the availability of such flexibilities and safeguards. In particular, the Briefing Paper criticises US trade policy and the emphasis on bilateral and regional free trade agreements as a way to ensure strong intellectual property protection despite the commitment to public health in the Doha Declaration. This is combined with what the paper describes as the indifference of other rich countries, where "all pharmaceutical companies selling medicines in a developing country, including European countries, benefit ... essentially 'free-riding' on US efforts to introduce TRIPS-plus rules."

The paper calls for new ways to promote patients over patents, noting the World Health Assembly Resolution of 2006 which established the inter-governmental working group. The World Health Organization (WHO) is tomorrow completing a public hearing in preparation for the meeting of the working group. Oxfam's paper focuses on several important cases, including the Glivec controversy.

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) was reported in Reuters today as arguing that access to medicines is not the major public health issue in the developing world, but rather inadaquate infrastructure. But Ellen 't Hoen of Medecins sans Frontieres (MSF) was quoted as saying "The current system based on patents and high prices to pay for innovation leads to rationing and leaves huge health needs neglected."

Oxfam is currently launching the Briefing Paper at BMA House in London, with highlights to be published at Patents vs Patients: Whose Rights Come First?

Call for Papers - Special Journal Issue

2006-11-04T09:43:00.000Z

Call for Papers
Special Issue September 2007
Intellectual Property, Medicine and Public Health

Deadline: 1 June 2007

This is a call for papers for a special issue of SCRIPT-ed, entitled “Intellectual Property, Medicine, and Public Health”

This issue will be dedicated to the discussion, analysis, and consideration of the inter-relationships of public health, intellectual property, and medical and pharmaceutical industry.

Submissions of short analysis pieces (up to 1000 words), longer analysis pieces (approximately 1000 to 3000 words), peer-reviewed articles, and student papers are invited.

All papers dealing with relevant topics and discussions will be considered, but some suggested areas of interest may include:

* access to medicines

* trade, bilaterals, and public health

* development

* gene sequences and patent law

* biopharmaceuticals

* patents and innovation

* data exclusivity

* stem cells

* property in human tissue

* genetic databases

* traditional knowledge and genetic resources

* more …

Informal enquiries may be made by email to the Guest Editor, Dr Johanna Gibson

Submissions by 1 June 2007 may be made by email to the Guest Editor, Dr Johanna Gibson or by mail to:

Dr Johanna Gibson
QMIPRI
Centre for Commercial Law Studies
Queen Mary, University of London
John Vane Science Centre
Charterhouse Square
London EC1M 6BQ
UNITED KINGDOM

WHO Public Hearing - Engaging the Private for Urgent Public Good

2006-11-03T16:03:00.000Z

The World Health Organization (WHO) is currently conducting an online Public Hearing to collect data and proposals from various stakeholders and actors, towards an analysis of intellectual property rights, innovation and public health. Running 1-15 November, the Public Hearing will accept contributions from a wide range of stakeholders and actors.

The contributions to the Public Hearing will be collected for the first official meeting (4-8 December) of the intergovernmental working group (IGWG), convened under Resolution WHA59.24, "Public health, innovation, essential health research and intellectual property rights: towards a global strategy and plan of action." Resolution WHA59.24 was adopted at the 59th World Health Assembly, after consideration of the recommendations of the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), which concluded with its report in April 2006.

The IGWG is open to all interested Member States, and IP-Watch reports that the WHO will also invite a wide range of observers, UN organisations, intergovernmental and nongovernmental organisations, as well as experts and selected public and private entities.

The IGWG will collect the data and proposals from various stakeholders through this Public Hearing and prepare an analysis of intellectual property rights, innovation and public health, to be submitted to the 61st World Health Assembly, to be held in May 2008. This analysis will develop a global strategy for sustainable needs-driven health research and development, with particular attention to those diseases affecting developing countries.

Some of these major diseases are those caused by helminth infections. Earlier this month, the WHO published guidelines on Preventive Chemotherapy in Human Helminthiasis, examining large-scale prevention and treatment programmes in helminth infections causing schistosomiasis or bilharzia, diseases which are disproportionately high in developing countries. The manual sets out the new strategy to fight these infections, involving a partnership of more than 25 organisations. As well as a significant public health concern, the WHO has also identified serious considerations with respect to human rights, in that sufferers are often ostracised and stigmatised as a result of these infections and the effects on the body. In the accompanying press release to the publication, Dr David Heymann, WHO Acting Assistant Director-General for Communicable Diseases, said that treatment and prevention of these diseases is urgent and "incontestable from all perspectives: moral, human rights, economic and global public good. The task is feasible and must be done."

Pharmaceutical companies and private donors "make good the gap" in delivering the support to poorer countries, as reported in the Financial Times (FT) earlier this month. According to the FT, all the drugs required for these are diseases are donated, except Praziquantel (for the treatment of bilharzia, formula at right). Merck manufactures the drug, and Bayer markets the drug for veterinary use. WHO has been in negotiations with both for some time, but to date there had been no agreement to provide the drug.

However, Merck is now co-operating with the WHO towards the production by 2008 of drugs to treat bilharzia at less than half the market cost, following reports of increased "pressure" on Bayer and Merck to donate "for human use a drug they sell for pets." Professor Lorenzo Savioli, Director of the WHO Department of Control of Neglected Tropical Diseases, said to the FT that the renewed action and fresh requests to the companies are in response to "a real market failure because schistosomiasis affects the poorest of the poor. But Bayer tells us to talk to Merck, and Merck says talk to Bayer."

The FT reports that Merck was approached by the WHO early this year in Spring, but that supplies were presently too small and production costs too high to allow for a viable mechanism to supply the drug at the costs and quantities required.

The FT also reports that Bayer originally helped develop praziquantel with WHO support in the 1970s for the treatment of patients in Africa. However, Bayer concluded that it could not produce the drug so that it would be affordable. Bayer's public profile, much maligned following the GM contamination of US rice imports, is unlikely to be assisted by what the FT reports as its reluctance to participate in initiatives to achieve distribution of the drug in Africa.

Meanwhile, Pfizer is providing open access to its library of 3 million chemical compounds to WHO-affiliated researchers on tropical diseases. Initially, access was granted to 12 000 compounds for the treatment of helminth infections and related concerns. The intellectual property rights arising from such programmes, however, are not clear, as no decision has been made on what will happen to any promising developments.

UK R&D Scoreboard 2006 - GSK Lifts UK R&D, But Size Does Matter

2006-10-31T15:08:00.000Z

The UK Department of Trade and Industry (DTI) has just released the figures for the 2006 R&D scoreboard.

The R&D Scoreboard 2006 provides information on the top 800 UK and top 1250 global companies based on R&D investment. The meaning of R&D for the Scoreboard is found in the UK in the Standard Statement of Accounting Practice (SSAP 13), which defines the concept based on the different definitions used by the Organisation for Economic Co-operation and Development (OECD) Frascati manual on expenditure for research and development. For global companies the International Accounting Standard (IAS 38) is used, also based on the Frascati manual.

The SSAP provides the definition of expenditure falling into one or more of the categories of pure or basic research, applied research, and development. The third category is particularly relevant to associated measurements of patent activity, in that it covers the "use of scientific or technical knowledge in order to produce new or substantially improved materials, devices, products ..."

72 UK companies made it into the Global 1250, with an increase in UK R&D expenditure (including 245 foreign owned companies) to £19.2bn (£17bn in 2005). This has been attributed to greater disclosure as well as an increase in R&D, which is particularly strong in pharmaceuticals in the UK. The previous decrease in UK 800 expenditure (1% decrease in 2005) has been replaced by an increase of 4% in 2006. GlaxoSmithKline (GSK) reported one of the larges, at £297million.

But others have criticised the increase as "distorted," pointing to the new accounting rule that insists on greater levels of disclosure in sectors not traditionally driven by or associated with R&D, such as banking. DTI senior industrialist and lead author of the report, Mike Tubbs (pictured right), in a report in The Independent, said "For the first time we had R&D from these companies. We knew they did R&D but we did not know it was that much." But a report in The Times suggests instead that "Britain is losing ground."

The Scoreboard for the Global 1250 shows that the pharmaceutical sector (along with software) is one of the fasting growing sectors with highest profitability. But it is second place in R&D, just behind technology hardware, putting 6 pharmaceutical companies in the top 20 (compared to none just 10 years ago). However, the number of patents granted per £10million is much lower than those for technology hardware and electronics.

The patent-to-R&D ratio for 12 sectors

According to the Scoreboard, around a quarter of the Global 1250 companies are mid-sized (sales of £50-500 million) with pharmaceutical companies making up 3/4 of these. Pharmaceuticals are the dominant sector in the UK, with the UK having the second largest proportion of pharmaceutical companies of all the top 7 R&D countries (with US having the greatest). Because the UK is particularly strong in pharmaceuticals, the report states that this explains why the UK does not have any companies in the top 20 for 2005 US patents.

Although the centenarian, GSK, is now the second-largest pharmaceutical company in the world (behind Pfizer), but a report in today's IP-Watch suggests that there is a distinct market advantage for small and medium-sized pharmaceuticals (SMEs) when it comes to neglected diseases and diseases in developing countries. Reporting on a seminar at the headquarters of the World Intellectual Property Organization (WIPO), co-organised with the Stockholm Network, IP-Watch notes the importance of "creative licensing deals" and cooperation with larger pharmaceutical companies. On patenting, Nikolaus Thumm, senior economic counsellor of the Swiss Federal Institute of Intellectual Property, told the meeting that there is a need to correct the "common misunderstanding" that the stronger the protection, the more innovation.

Free Public Workshop - London, 13 November 2006

2006-10-26T10:32:00.001+01:00

Criminal Enforcement Directive

Let the Punishment Fit the Crime?

The Patenting Lives network will be conducting a free public workshop on the proposed European Directive on criminal measures aimed at ensuring the enforcement of intellectual property rights (Criminal Enforcement Directive).

The workshop will commence with a discussion by a panel of experts, looking at the possible implications of the Directive for patentable technologies and patent practice.

Expert Panellists

Gwilym Roberts, Partner, Kilburn & Strode Patent Attorneys

Julian Heathcote Hobbins, Senior Legal Counsel, FAST (Federation Against Software Theft)

Phillip Johnson, Barrister, DTI Legal Services, Legal Adviser to the UK Patent Office

(Chair Johanna Gibson)

The event will commence at 6pm, 13 November 2006, and will be held at the Centre for Commercial Law Studies (CCLS) in the QMIPRI Seminar Room, John Vane Science Centre, Charterhouse Square, Queen Mary University of London (map).

The workshop is FREE but numbers are limited, so please register by email to Johanna Gibson.

This is the first in a series of Patenting Lives public workshops on current issues in patent law. Stay tuned for more to come.

For more details on the Patenting Lives project and network, please visit patenting lives or the patenting lives blog

Competition Inquiry into Johnson / Pfizer Deals

2006-10-25T22:33:00.000+01:00

The European Commission has commenced a competition inquiry into Johnson & Johnson's planned acquisition of Pfizer's consumer health interests.

The Commission's Competition Directorate will decide at the end of next month whether the sale can proceed or whether a full-scale investigation is warranted. If the latter route is taken, this will delay the process by a further 90 days.

The proposed deal was announced in June this year and will result in Johnson & Johnson having a substantial monopoly over consumer health products. Jonathan Todd, speaking for the Commission's Competition Directorate, was quoted in an article in The Times saying, "Our concern is whether or not there may be an adverse effect on consumers, pricing and competition."

Earlier this month it was reported that US anti-trust regulators forced Johnson & Johnson and Pfizer to agree to sell Zantac (to Boehringer-Ingelheim Pharmaceuticals, for US$509.5M), after there were concerns that this product overlapped with some Pfizer products.

Meanwhile, as reported in the Financial Times last week, Lloydspharmacy has asked the Office of Fair Trading (OFT) in the UK to investigate Pfizer's exclusive agreement with UniChem to act as a single distributor for its drugs in the UK. UniChem is part of Alliance Boots, which also runs the large rival pharmacy chain, Boots.

Pfizer claims that the deal is to control the supply chain in a fight against counterfeit drugs, but after the expiration of patent protection for several of its key sellers - including Zythromax (antibiotic), Diflucan (antifungal), and Zoloft (antidepressent) - the agreement seems to be equally about limiting competition from cheaper, generic versions. Other British pharmacies and drug distributors are concerned that this will lead to an anti-competitive monopoly, adversely affecting consumers with higher prices. According to a recent report in the Financial Times, Pfizer's drugs account for around 15% of the UK's £10.3 billion pharmaceutical market. Furthemore, pharmacies will be forced to use UniChem as the exclusive provider of Pfizer's branded drugs, leading to concerns that Pfizer will be able to control the discounts available to retailers as well.

James Harding, in an opinion piece in the The Times, suggests that public scrutiny will exonerate Pfizer, but he is correct to note that important questions being asked, "Is Pfizer just hyping up the counterfeits argument in order to cut out competition and take control of pricing?" and "Will UniChem provide as reliable a service to other pharmacies as it does to its own Boots stores?" In other words, the Pfizer-UniChem agreement will in effect control each level of the chain, right down to the deals with individual retailers themselves. By "taking a risk," Harding seems to think Pfizer is exonerated. But surely that is the nature of the entrepreneurial business models - taking risks pays much higher dividends. It is not clear that the risk of Pfizer grazing a knee if UniChem stumbles will be a sufficient check and balance against the potentially anti-competitive nature of this deal.

The British Association of Pharmaceutical Wholesalers (BAPW), the main trade body in the UK, is likely to make a similar complaint with the OFT. The Chairman of BAPW, Ian Brown lee, said to The Times, "With a single supplier the delivery system cannot ensure that pharmaceutical products are there in the dispensary when they are needed. Profit is being put before patient safety with a breathtaking arrogance." UniChem is one of its members.

EU Council Adopts EC Regulation on Paediatric Medicines

2006-10-23T17:52:00.000+01:00

The Council of the European Union (EU) announced today that it has adopted the EC Regulation on medicinal products for paediatric use.

Today's press release states that the new Regulation aims to improve child health, as considered in more detail in earlier background material accompanying the original proposal. The Regulation sets out specific requirements for the authorisation and use of medicines in children, in response to a concern that around 50% of medicines used to treat children are in fact not tested or authorised on children. The improvement to the health of children in Europe is said to be likely to come from better research, development and authorisation of paediatric medicines. The new Regulation creates a new system through various strategies, which are stated as aimed at achieving better availability of paediatric medicines throughout the Community and removing obstacles to trade of medicinal products within the Community.

As well as dealing with the appropriate standards of research, clinical trial, and authorisation, the Regulation also looks to improve information on the use of paediatric medicines. Obligation in this area are to be accompanied by certain incentives created in the Regulation.

Of particular interest is the incentive with respect to medicines still protected by monopoly (patent or supplementary protection certificate (SPC)). The Regulation introduces new obligations to submit (as part of the procedure for market authorisation) results of clinical studies in accordance with a paediatric investigation plan or proof of a waiver where the medicines of no paediatric use. These obligations are accompanied by an incentive in the form of the extension of exclusive rights (an additional 6 months) on the basis that it takes longer to test and authorise paediatric medicines. In the case of SPCs, extensions are available only for products authorised in all Member States and for which marketing authorisation procedures are complete.

In the drafts leading to final text, discussions rejected proposals to exclude extensions for products that have already received the protection of data or market exclusivity for the same paediatric use in the EU. Similarly, the Commission rejected earlier drafts seeking to amend the proposed text to exclude an extension of the SPC for products that have already benefited from patent protection covering the paediatric use. The Commission claimed that such exclusions would compromise the policy objective of encouraging greater research into medicines for children. Nevertheless, in keeping with this rationale, importantly the extensions are available as an incentive only for research entered into after the new Regulation has entered into force.

However, in May this year, the European Court of Justice (ECJ) ruled out SPCs for new formulations of known active ingredients, in the Massachusetts Institute of Technology (C-431/04). This was despite an earlier opinion of the Advocate-General. The Court ruled: "Article 1(b) of the Regulation must be interpreted so as not to include in the concept of 'combination of active ingredients of a medicinal product' a combination of two substances, only one of which has therapeutic effects of its own for a specific indication, the other rendering possible a pharmaceutical form of the medicinal product which is necessary for the therapeutic efficacy of the first substance for that indication." This may limit the incentive in respect of extensions of SPCs for new uses (paediatric) of known products.

Regarding off-patent paediatric medicines, the Regulation introduces a new kind of marketing authorisation, referred to as the Paediatric Use Marketing Authorisation (PUMA). Such medicines must have been appropriately tested for paediatric use. The Regulation also includes provisions on the funding of research into the use of off-patent medicines for paediatric purposes.

Medicinal products for the treatment of serious diseases affecting fewer than 5 in 10 000 people in the Community are often referred to as "orphan drugs," because of their limited interest to the pharmaceutical industry. The Orphan Drug Regulation currently provides for 10 years market exclusivity, in order to provide incentives to bring such treatments to market, which the new Regulation is expected to extend to 12.

The Regulation also creates a new scientific committee, an expert committee within the European Medicines Agency (EMEA). This Committee will be primarily responsible for the assessment and agreement of paediatric investigation plans and waivers (described above).

The new Regulation amends 3 European instruments - Council Regulation (EEC) No 1768/92 creating supplementary protection certificate; Regulation (EC) No 726/2004 for authorisation and supervision of medicinal products for human and veterinary use (establishing the EMEA); and the Clinical Trials Directive 2001/20/EC. The original proposal text and amended text are available. The text of the adopted Regulation is likely to be published in the Official Journal in the next couple of weeks.

Novartis and the Challenge to Indian Patent Law - Global Pharmaceutical Policy

2006-10-21T18:06:00.000+01:00

At the recent 23rd Assembly of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), held in Geneva, it was announced that a new code of marketing ethics is to be launched next year, according to a report in IP-Watch. But current events possibly raise questions as to how effective any code might be in the face of what is sometimes described as the litigation "business model."

Presenting a keynote to the meeting, Mr Fred Hassan (pictured at right), Chairman and CEO of Schering-Plough and the new President of IFPMA, declared that IFPMA has made significant progress on marketing and clinical activities. He noted the voluntary guidelines developed and used in the US, and explained that implementation is now more important than strategies.

On clinical trials, Mr Hassan noted the IFPMA initiative in delivering public information. Earlier this year, IFPMA launched the second stage of the Clinical Trials Portal, developed with IBM. According to the background information provided by IFPMA, the aim of the service is to facilitate public access to pharmaceutical clinical trial data. The portal will operate as an internet search engine, allowing patients to locate information to clinical trials, both completed and in progress, and is sponsored by originator (as opposed to generic) pharmaceutical companies around the world. The portal searches the listings (registries) of on-going clinical trials and the results of completed clinical trials. IFPMA maintains that the presentation of results is "in a standard, non-promotional, summary format."

The 1st Stage of the Clinical Trials Portal was launched in September last year, but the Stage 2 upgrade allows greater functionality, including search criteria in French, German, Japanese, and Spanish, as well as the original English of Stage 1. The 2nd Stage also offers a more advanced search function as well as the use of the MedDRA and MeSH medical dictionaries to provide multilingual synonyms.

In his keynote, Mr Hassan importantly identified 4 significant obstacles to improving health care: "barriers to access," "barriers to innovation," regulatory systems, and the "barrier to openness, transparency and accountability." To overcome the first obstacle, Mr Hassan argued for improved access to health education and information as well as new interventions. On the latter, however, the critical obstacle was seen to be administrative, including that of regulatory delays (in the approval and registration of new drugs), and practices with respect to patent monopolies were not really addressed. Indeed, in comments on "barriers to innovation," intellectual property was described as "the engine of innovation." Mr Hassan argued that "only a handful of countries contribute the innovation that drives improved health care throughout the world. The US carries a disproportionate load." The new President looked to "Private entrepreneurship and risk-taking, in open markets" as the mechanism to improve innovation and resource allocation and said the "the protection of intellectual property" is "absolutely critical."

Indeed, earlier this year, in response to the first report of the World Health Organization (WHO) Commission on Intellectual Property Rights, Innovation and Public Health (CIPI H). The Report, entitled Public Health: Innovation and Intellectual Property Rights, generated a strong response from IFPMA, which expressed concern that the Report "surprisingly recommends that developing countries should make use of compulsory licensing," and criticised the Report as underestimating the role of patents. Ellen 't Hoen, from Medicins sans Frontieres (MSF) Access to Essential Medicines Campaign, however, welcomed the report. Writing in the WHO Bulletin, she described the report as presenting "a wealth of evidence and analysis in support of the view that the current system of drug development is fundamentally flawed and leaves huge health needs unmet."

Mr Hassan succeeds Dr Daniel Vasella (pictured left), Chairman and CEO of Novartis and IFPMA President 2004-2006.

Novartis has come under criticism lately, in its challenge to Indian patent law. Novartis had obtained exclusive marketing rights for 5 years for its cancer drug, Glivec (marketed as Gleevec in the US) a temporary monopoly until the Examiner submits a report on the invention (Patents Act, Chapter IVA). However, because it was decided that the invention was not an invention, the exclusive marketing rights were withdrawn. The application failed for lack of inventive step (obviousness) because it was a new form of a known substance. The refusal (analysed in an article by Manisha Singh Nair) was made on a number of grounds. But a substantial basis was provided by Section 3(d) of the Indian Patents Act, which provides that "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance" will not be sufficiently inventive to warrant patentability. In other words, India is refusing to allow Swiss-type claims.

Under the 2005 amendments to Indian patent law (to become TRIPS compliant), every application for exclusive marketing rights is treated as a request for examination. Further, any person or group may now file a pre-grant opposition. In this case, the Cancer Patients Aid Association and several generic pharmaceuticals (including Natco) did so in the Chennai patent office, on behalf of cancer patients.

In response, Novartis filed in May 2006, claiming that Indian patent law is unconstitutional and also contravenes international trade rules, taking the complaint to the Madras High Court, which sits in Chennai. A press officer from Novartis, speaking to IP-Watch, described the action as evidence of "Novartis' strong commitment to defending international intellectual property standards and its right to obtain patents for its innovative compounds under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)." Daniel Vasella also spoke to IP-Watch, saying that the litigation was "a question of principle," and that unless Novartis pursues this it "would undermine the whole system."

According to Reuters, Novartis is claiming that Section 3(d) is not TRIPS-compliant. However, Article 27(1) of TRIPS arguably does not go so far as to mandate the protection of new use, or to define what a country must protect as an invention. It simply says, "all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application." The exclusions relate to subject matter (methods, plants and animals) and such exclusions are included in the European Patent Convention (EPC), Article 52. On the other hand, a Swiss-type claim is a known product. It could be argued that this therefore forms the state of the art, and therefore Swiss type claims may be refused by countries on the basis that they are not new. Indeed, Swiss type claims are dealt with under Section 2(6) of the UK Patents Act 1977, further indicating that they are a matter of novelty. The Indian Act, however, excludes "new use of a known substance" in Section 3, "What Are Not Inventions."

The Berne Declaration (BD), a Swiss non-governmental organisation, has made a statement that section 3(d) is in compliance with TRIPS. Further, BD states that each member is entitled to introduce a patent regime compatible with its socio-economic context provided they are compliant with the minimum standards of TRIPS (Art 8), a view supported by the 2001 Doha Declaration on TRIPS and Public Health (Doha). The BD cites the WHO CIPIH Report as supporting this view. On page 34, the report states: "countries may devise their patent systems to seek teh best balance, in their own circumstances, between benefits and costs. Thus developing countries may determine in their own ways the definition of an invention, the criteria for judging patentability ... provided these are consistent with the relevant articles of TRIPS." Further, the report importantly states that, "Under TRIPS they may also exempt from patentability ... new indications of known products which amount to a therapeutic method."

Ellen 't Hoen said to IP-Watch, "This has South Africa written all over it" and has said in an MSF press release, "If Novartis' challenge against the Inidan patent law is successful, a key safeguard that can protect the production of affordable medicines will be lost." As the Times of India has reported, the cost of one month's supply of Glivec is Rs 1.10 lakh (Rs 110 000), whereas a generic equivalent is available for Rs 1100.

Civil society organisations in Switzerland, led by BD, have sent an open letter to Mr Vasella, in which 22 organisations and personalities demanded the withdrawal of the legal action. Those endorsing the letter includeed MSF Suisse, medicuba, Association of European Cancer Leagues (ECL), CO-OPERAID, and, in a private capacity, Mrs Ruth Dreifuss, former Swiss cabinet minister and Chairperson of the CIPIH, WHO. But in response to the letter, John Gilardi of Novartis has told swissinfo that "It's important that we applaud the efforts India has made to improve its intellectual property protection, but this is about ensuring that a patent for Glivec, which is recognised in over 40 countries, is also recognised in India." According to the article, Mr Gilardi claimed that Indian patent law clearly exceeded the flexibilities available. Along the lines of Mr Hassan's statement that intellectual property laws are the "engine of innovation," Mr Gilardi told swissinfo "Without a reward for innovation, there will be no innovation."

The IFPMA meeting also included a keynote presentation by Pascal Lamy Director-General of the World Trade Organization (WTO) (pictured at left, speaking at the 6th Ministerial Conference, Hong Kong, NGOs Roundtable Forum). Mr Lamy has recently spoken on the "bilateral disease" of free trade agreements, and the EU's troubling emphasis on bilateral deals. In his address to IFPMA, Mr Lamy said "I am convinced that there is no acceptable alternative to completing the Doha Round." As recently reported in the Financial Times (12 Oct, "WTO head flags trade rules"), Mr Lamy told the meeting that the WTO had not received a single notification of a developing country issuing a compulsory licence, suggesting that the current flexibilities are too complex to be used in practice. "To be frank," he said, "I see that as a problem."

The WHO CIPIH Report has also noted the "emerging development" of the "growning number of bilateral and free trade agreements which include higher standards of protection that erode these flexibilities" considered earlier. And even EU business is wary of bilaterals. Speaking at UNICE, Michael Treschow, President of the Confederation of Swedish Enterprise, recently told the Financial Times (18 Oct, "Ericsson chief warns EU") that "It is not countries that do business with countries but companies that do business with companies." Peter Mandelson, European Commissioner for External Trade, defended bilaterals and rejected stories of his "clash" with Africa-Caribbean-Pacific (ACP) countries in an address to the European Socialist Party Conference on Economic Partnership Agreements, last Thursday. This is despite recent press that ACP countries will reject trade deals with the EU. In an article in FT Europe, Dame Billie Miller (pictured at right) Barbados trade negotiator, criticised Mr Mandelson's emphasis "economic partnership agreements" as pure trade negotiations. She said, "For us the development dimension is critical. We made our concerns known but the Commission has continued to talk the talk."

Pascal Lamy hosted an online chat last Wednesday, attracting around 150 questions on the Doha Round and the future of the WTO. The many questions in the transcript include discussions on multiculturalism in trade, life patents, controls on bilateral agreements, and the future of the Doha Round.

Lamy Warns Against Bilateral "Disease"

2006-10-18T13:18:00.000+01:00

Pascal Lamy has warned that bilateral and regional talks may be an obstacle to a resumption of the Doha Round of negotiations.

Speaking yesterday at "Why Do Companies Care About Europe," organised by the Confederation of European Business (UNICE), the Director-General of the World Trade Organization (WTO) warned that the increased emphasis on regional negotiations and bilateral trade agreements may undermine attempts to resume multilateral negotiations. In an Associated Press report, Lamy is quoted as warning, "All efforts (should be) on getting a multilateral deal. In the case of a failure, the poorest will be hit hardest."

In an address to the International Trade Committee of the European Parliament yesterday, Lamy said that the WTO would try to put more pressure on countries pushing such policies, to re-start the negotiations. Such countries include the US, Australia, Japan, India, Brazil, and of course, the EU. As a report today says, "Mandelson's bilateral plans will harm poor." In his speech, Lamy said that the failure of the trade talks would be like "a slowly developing disease that would progressively sap the strength of the multilateral trading system built up over the past 50 years, damaging its economic lungs, its political heart, and its systemic bone structure."

Lamy will be hosting an online chat today, 16.30-17.30 Geneva time - WTO in Crisis: Which Way Forward?

EU Trade Pacts - UK Calls for Attention to Development

2006-10-16T10:37:00.000+01:00

According to a report today in the Financial Times, UK ministers have written to the European Commissioners for Trade and Development urging greater consideration of development issues when pursuing trade pacts with developing countries, ahead of today's trade meeting in Luxembourg. This comes when India and the EU agreed last week to work towards a new bilateral trade and investment deal by 2009.

In an open letter to Louis Michel, EU Commissioner for Development, and Peter Mandelson, EU Commissioner for Trade, the two ministers - Ian McCartney, UK Trade Minister, and Gareth Thomas, Development Minister - have said, "We are concerned about the current state of the negotiations and want to see these agreements deliver real benefits to ACP [Africa, Caribbean and Pacific] countries."

In particular, as seen in yesterday's post, free trade agreements are being criticised as merely obliging developing economies to accept foreign competition and intellectual property laws in ways that may be detrimental to domestic policies and to economic development. Similar issues are raised in the UK letter to the Commission, revitalising the "Singapore Issues" that have been marginalised in international trade talks. The so-called "Singapore Issues" have been seemingly insoluble due to disagreements over vital development concerns, particularly at the World Trade Organization (WTO) 5th Ministerial Conference in Cancun, 2003. Development remained on the agenda at the 6th Ministerial Conference in Hong Kong, 2005, but since the recent collapse of the Doha Round, development issues are increasingly vulnerable to being silenced through bilateral agreements.

In a recent speech at the London School of Economics and Political Science (LSE), Peter Mandelson said that the EU remains committed to sensitive and "deep" free trade agreements. And in a comment in India's Financial Express, Mandelson reiterates his commitment to the "sensitive issues," saying that the EU-India agreement "would have to be deep and substantive ... We also need to improve the enforcement of rules on the protection of intellectual property rights."

But an article in today's Guardian newspaper, suggests that such agreements may not necessarily be sensitive to development. In the article, Angela Balakrishnan refers to the Commission letter leaked last May, which revealed pressure from Peter Mandelson on the UK Prime Minister, Tony Blair, "to take a more moderate line in Britain's pro-poor country approach to trade liberalisation." As Balakrishnan notes, the Commission accused the UK government of being influenced by celebrities and non-governmental organisations (NGO) in its policies.

Or perhaps it's just a campaign of distraction.

FTAs - A Threat to Public Health

2006-10-15T18:53:00.000+01:00

Representative Henry Waxman and Senator Edward Kennedy have requested the Government Accountability Office (GAO) to investigate the impact of trade negotiations and policy on public health and access to medicines in developing countries.

In a press release, the request for an investigation of the Administration's trade negotiations is called for in the context of the "negative effects on developing countries' access to medicines." Referring to the Trade Act of 2002 (US Trade Promotion Authority Act), which obliges the government to respect and promote public health in all countries as part of US trade practices and policy. The Trade Act of 2002 grants the US President authority to negotiate bilateral trade deals with other countries, the approval of which is streamlined (fast track authority) with Congress unable to amend such agreements, merely to approve or reject. Such fast track authority was used in Uruguay Round of negotiations leading to the establishment of the World Trade Organization (WTO) and the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Renewed in 2002, the fast track authority will expire in July next year unless extended by Congress.

The letter to the Comptroller General of the GAO refers to the three objectives dealing with intellectual property in the Trade Act of 2002 - IP protection, market access, and public health - and argues that, taken together, these outline the "clear vision for trade negotiations related to intellectual property." Further, "we would like to learn to what extent the third objective, to respect the Doha Declaration on TRIPS and Public Health, has been pursued."

The letter to the Secretary of Health and Human Services, US Department of Heal th and Human Services, refers specifically to a letter from William R Steiger (pictured at right), HHS Special Assistance for International Affairs, sent to the Acting Director General of the World Health Organization (WHO) insisting upon the withdrawal of the study, "The Use of Flexibilities in TRIPS by Developing Countries: Can They Promote Access to Medicines?" The study, prepared by Sisule Musungu of South Centre and Cecilia Oh of the WHO, criticises the impact of US trade policy on international public health and access to medicines.

The action by the two politicians comes at the same time that the Thai Network of People Living with HIV/AIDS (International HIV/AIDS Alliance Thailand) is campaigning against the Thai-US free trade agreement (FTA) in the US. The campaign was launched earlier this month and will continue until 29 October throughout major US cities. In a recent report in the Bangkok newspaper, "The Nation," Nimit Tienudom, Director of the AIDS Access Foundation described the campaign as informing US citizens about the impact of US trade policy on access to HIV/AIDS treatments. In an earlier article in the same newspaper, Tienudom criticised the Thai-US FTA: "Under the current law and trade agreements we have, there still are ways out such as the compulsory licensing measures ... If we accept the FTA, all doors will be shut."

These are concerns not only in agreements with developing countries, but also in those with countries like Australia. The Australia-US FTA (AUSFTA) has been criticised widely, particularly in the US objection to Australian health policy as a barrier to trade. The Pharmaceutical Benefits Scheme (PBS) is the specific focus of that objection (and is the subject matter of a side letter to the AUSFTA). As a result, public health and medicines were major aspects of the negotiations and of the campaigns both for and against the AUSFTA. Significantly, the imposition of the US economic model in this area of domestic policy was seen seriously undermining government capacity and democratic principles in Australia. Annex 2-C (Pharmaceuticals) to Chapter 2 (National Treatment and Market Access for Goods) establishes a joint Medicines Working Group, which many commentators have criticised as introducing US-style pricing for medicines and undermining public health policies of affordable medicines. Further, Article 17.10 (Measures Related to Certain Regulated Products) and mandating of 5 years data exclusivity may delay access to affordable generic versions of brand-name drugs.

FTAs have also been criticised for rendering traditional and indigenous knowledge increasingly vulnerable to appropriation through the intellectual property protection of the bioprospecting activities of pharmaceutical companies. In particular, the DR-CAFTA has been described in the Latinamerica Press as paving the way for biopiracy, having "opened the door to foreign ownership of the right to exploit the region's abundant and diverse tropical flora."

The international network, bilaterals.org, has just published its very useful background paper, "Overview of Bilateral Free Trade and Investment Agreements." The paper was prepared for the FTA Watch "Fighting FTAs" international strategy workship, held in Bangkok in July this year.

Biologics - What's in a Name?

2006-10-14T13:12:00.000+01:00

The World Health Organization (WHO) Expert Committee on Biological Standardization will meet at the end of this month in Geneva and will consider, among other issues, whether generic biotech drugs can carry the same clinical name or nonproprietary name as the brand-name drugs. Biotech drugs - also known as biologics or biopharmaceuticals - are some of the most expensive products on the market and form part of the arsenal against HIV/AIDS, cancer, and diabetes.

The WHO has established Guidelines on the Use of International Nonproprietary Names (INN) for Pharmaceutical Products, The WHO Programme on INN released a Review in June this year, which noted that INNs have not been assigned to blood biologicals and immunoglobulins, but have been used for some fusion proteins, gene therapy products, and transgenics. Skin substitutes are considered outside the system and vaccines are also currently not included in the system. However, the Expert Committee on Biological Standardization has made recommendations resulting in the assigning of some names.

In a recent report in The Independent, Danny Fortson describes political pressure for large-scale production of generic biotechnology drugs as a "fresh financial threat" to the pharmaceutical industry. But many commentators are concerned that this perceived "threat" is really simply an anxiety over protecting de facto monopolies in biological medicines. Such political pressure in the US comes recently from a new US Bill, aiming to improve access to lower cost drugs in the important area of pharmaceutical development.

US politicians, Representative Henry Waxman (of the Hatch-Waxman Act, establishing a system for generic drug approval in the US), and Senators Charles E Schumer and Hilary Clinton, have introduced the new bill, known as the "Access to Life-Saving Medicines Act." The aim is to establish procedures to facilitate approval of generic versions of biotech drugs. The press release notes the absence of statutory procedures for biotech drugs, leading to the potential problem of indefinite monopoly pricing, despite the expiration of patent protection.

The Bill has been strongly supported by the Generic Pharmaceutical Association (GPhA), which has stated "Introducing competition into the biopharmaceutical field would also yield tremendous cost savings for consumers ... We applaud Rep. Waxman and Senator Schumer for their true leadership."

Meanwhile, industry associations have maintained their objections, arguing that complex biopharmaceuticals cannot be copied in ways similar to traditional medicines, and so the application of traditional approval routes will not be appropriate. For instance, the VFAbio (Biotechnology within the German Association of Research-Based Pharmaceutical Companies) has urged that "such generics cannot exist."

In January 2006 the European Medicines Agency (EMEA) adopted its first positive opinion for a biosimilar, when it declared Omnitrope (Novartis) to be comparable to Genotropin (Pfizer), for which market authorisation was granted by the Commission in April (Omnitrope was later approved by the Food and Drug Administration (FDA)). In April the EU finalised its policy and legal framework for biosimilars when the EMEA adopted guidelines on the approval process for similar biological medicines.

However, the consultation on the draft guidelines attracted similar arguments, with the European Association for Bioindustries (EuropaBio) in its submission arguing that the application of the term "comparability" (from traditional manufacturing processes) to the biotech medicinal product is inappropriate. Similarly, the submission of Emerging Biopharmaceutical Enterprises (EBE) (European Biopharmaceutical Enterprises) emphasised that "Because no two cells are exactly alike, each biological medicinal product is distinct and cannot be copied exactly by a different company," while the Biotechnology Industry Organization (BIO) noted in its comments that "in important respects all protein products are unique, that each must be treated as such, and that tests performed by an innovator to demonstrate quality, safety and efficacy of its own product may not be relevant to a claimed-similar product." But Greg Perry, Director General of the European Generic Medicines Association (EGA) stated at the Biosimilars conference in London, that "The current level of biological science and recently enacted pharmaceutical legislation in Europe mean that the next generation of affordable medicines is no longer a distant dream, but rather a soon to be realised reality."

The EGA will be holding the 5th Annual Symposium on Biosimilars, "Biosimilar Medicines: Off the Starting Blocks," in London, May 2007. More details will be available early next year.

Lamy Speech to IFPMA - Public Health is a Trade Issue

2006-10-12T22:49:00.000+01:00

This week, the Director-General of the World Trade Organization (WTO) praised efforts to improve access to medicines in developing countries, in his address to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

The Director-General, Pascal Lamy, delivered a keynote speech to the 23rd Meeting of IFPMA in Geneva, Wednesday night, in which he said "trade can work to improve health conditions which we know is essential to economic and social development."

A couple of months ago, IFPMA took part in a Geneva Forum, "Towards Global Access to Health," although the IFPMA participation was concerned largely with counterfeits as a health threat. Others may argue that this is more an issue of the "trade threat," and one which has been used strategically to control the entry of less expensive imports into certain markets.

The World Health Organization (WHO) defines a counterfeit drug as a one which is "deliberately and fraudulently mislabeled with respect to identity and/or source." However, consumer groups and other civil society actors have raised concerns that industry is using the "menace" of counterfeit drugs as a means by which to hinder the import of cheaper medicines. For instance, in the Philippines, Republic Act 8203 has been criticised for codifying such obstacles in response to intense lobbying. Recently, attorney Elpidio Peria has recommended amending the law to remove the clause, "an unregistered imported drug product," from the definition of counterfeit drug in the law.

Recognising the problem of the variable definition of counterfeit drug, WHO recommends a uniform definition of counterfeit drug as an essential part of effective exchange of information on these issues as well as appropriate and meaningful responses to public health.

WTO - Update on Article 31bis

2006-10-11T20:52:00.000+01:00

The World Trade Organization (WTO) has just updated its information on intellectual property and public health to provide more information on the 2005 decision to amend the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).

WTO members approved an amendment to TRIPS, 6 December 2005, putting in place the 2003 decision on patents and public health, sometimes referred to as the waiver on public health. The 2003 decision aimed to facilitate access of developing countries to cheaper generic medicines, particularly in circumstances where the country lacks the infrastructure to produce the medicines itself under a compulsory licence. However, it has been criticised as too administratively complex and burdensome to be a truly effective means to remove obstacles to access.

The new provision, Article 31bis, will be formally in force when a minimum of 2/3 of WTO members ratify the change. The deadline of 1 December 2007 has been set in order to achieve this, until which time the waiver continues to be in force.

The WTO has set up a page recording countries that have accepted the amendment. To date, only 2% of countries have ratified the change (3 countries out of a possible 149). These are the United States (a matter of days after 6 December), Switzerland, and El Salvador (both in September this year).

Patent Filings = Innovation? Audi's Advertising Agency Thinks So

2006-10-08T15:55:00.000+01:00

(Also posted on Patenting Lives blog)

Not quite directly related to concerns of intellectual property aspects of medicine, but certainly concerned with patent law, and so interesting I could not resist blogging it. The latest Audi commercial features "patent filings" as a slogan. The campaign hinges on a link between filings (not even granted patents, but just filings) and prestige and innovation.

It's the latest campaign for the Audi A6, entitled "A6: Patent No VOR5PRU7NGDUR6CHT3CHN1K" (catchy, yes?). The advertisement features a man and his dog walking along a deserted country road in the middle of the night. He hears a sound in the sky and looks to the stars, a fast-moving object speeds through the sky, interspersed with quick images of patent specification documents. The advertisement reaches the climax slogan, "To date, NASA has filed 6509 patents. In development the A6, Audi filed 9621" ... as an A6, after orbiting the earth, plunges out of the sky and into the ocean.

Now that's compelling advertising.

A Market in Transplants

2006-10-08T11:16:00.000+01:00

An Associate Professor from the Yale University School of Medicine has recommended payments for living organ donations.

Amy Friedman (Organ Transplantation and Immunology) advocates a regulated system for the payment of organ donors in a recent article, published in the British Medical Journal (BMJ). Friedman suggests that there are tangible benfits of living donor transplantations not only for the recipient but also their family members, and hospital staff (in their ability to "fulfil" the tasks of their employment), and ultimately taxpayers (otherwise obliged to support various treatments required without transplantation, such as dialysis). Arguing for this kind of economy for transplantation, Professor Friedman notes that living donors are nevertheless prohibited from receiving valuable consideration for their gift. However, if a living donor subsequently requires a transplant, then they will receive a kind of "tangible benefit" in that they are moved to the top of waiting lists for organs from deceased donors.

Friedman argues that this moral recognition of a reward suggests the basis for other types of reward, including monetary. On this point, she raises the legality of payment in the US for donations of other bodily material, including blood, sperm, and eggs, as well as legalised mechanisms for the "use of the intact, functional body" in surrogate pregnancy and prostitution in order to derive a kind of societal benefit.

In this area, payment to research volunteers is especially relevant when considering the "risk" in the relationship. Particularly in the context of the recent controversy in the UK regarding the Northwick Park drug trials, the adequacy of information and the validity of the consent to participate raises important questions. The information provided to volunteers is critically important to the individual calculation of the risk assumed by those volunteers.

Friedman concludes that the establishment of a regulatory system of payment would improve the equitable access of recipients to donor organs, and would not simply exploit the needy. Rather, it would bring "black economies" and unregulated activities, such as those recently reported in China, "out of the closet."

Friedman suggests, "If military service can be recognised with inducements such as paid education, enlistment bonuses, and financial recovery for injury or mortality, why should the decision to donate an organ be viewed any differently?"

Data Exclusivity Concerns in India

2006-10-06T13:30:00.000+01:00

Data exclusivity measures are raising concerns in India. Following lobbying from multinational pharmaceutical companies, it has been reported by Sarah Hiddleston in The Hindu newspaper that the Indian government is expected to amend drug registration laws to bring in data exclusivity provisions, without public debate.

An interministerial committee, convened by Ms Satwant Reddy (Secretary, Department of Chemicals and Petrochemicals) is expected to recommend the protection for data for 5 years in a report due to be released in the next 2 weeks. This will lead to a draft bill amending the Drugs and Cosmetics Act to provide for the new measures.

Article 39.3 of the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) relates to "Protection of Undisclosed Information" and obliges member states to provide protection for undisclosed test and other data against unfair commercial use. Pharmaceutical companies have lobbied against the checking of generic competitors against originator's clinical data, arguing that this amounts to "unfair commercial use." This kind of reasoning has been rejected by many groups, contending that the provision relates to anti-competitive conduct and industrial espionage, and should not be interpreted as a provision for the creation of further exclusive rights.

According to The Hindu report, representatives from the the Department of Health, the Department of Eco nomic Affairs and the Indian Council of Medical Research (ICMR) are also opposed to data exclusivity measures.

The Department of Industrial Policy and Promotion has responded with the suggestion of seven safeguards, but at least 3 have been criticised as failing to address the issues. In particular, the problem has been described as being exacerbated by the attempt to integrate two different systems and functions - legal and regulatory. As Senior BJP Leader, Murli Manohar Joshi (pictured at left), argued earlier this year, the government must take account of the World Health Organization (WHO) recommendations to maintain the separation between intellectual property rights and drug regulation. In other words, linking patent protection to what are basically questions of market and regulatory approval is creating significant obstacles to public health and greater expectations as to exclusive rights. On this issue, Hiddleston describes this as an "administratively difficult and ethically questionable" link between drug registration and patent protection. Further, it links regulatory systems to technical expertise on the validity of the patent itself.

Hiddleston suggests that appeals to the national interest will be made to justify the new measures, but as she says, "It also says much about where the government's priorities lie."

CAFTA - Dominican Pharma Criticises US Demands

2006-10-06T12:56:00.000+01:00

The US requirements in the area of pharmaceuticals in the Central American Free Trade Agreement (CAFTA) have been described as "abusive demands" by the Dominican Association of Pharmaceutical Industries (INFADOMI).

In an earlier post, FTAs and Public Health, it was reported that negotiations had been delayed over issues regarding data exclusivity and the new pharmaceutical products. In an article in Dominican Today, the changes to the definition of "new product" are a threat to local industry and are in addition to those already specified in the document. This is despite an earlier story, where Hans Hertell (at left), Ambassador to the US, suggested that the impasse over pharmaceuticals and free trade was close to being resolved, and that there would be no further requirements in addition to the original requirements for implementation.

USPTO to Reexamine 3 Stem Cell Patents

2006-10-05T10:23:00.000+01:00

A request to the United States Patent and Trademark Office (USPTO) to reexamine 3 patents relating to stem cell technology has been granted.

The requests came from California-based consumer group, Foundation Taxpayer and Consumer Rights (FCTR), and were filed in July on the Foundation's behalf by the Public Patent Foundation (P UBPAT).

The patents are owned by the Wisconsin Alumni Research Foundation (WARF) whose researchers include James Thomson (pictured at left), who led the team which, in 1998, made the first successful isolation of human embryonic stem cells. Thomson later founded Cellular Dynamics International (CDI), a private biotechnology company based in Madison, Wisconsin. Last year, the State of Wisconsin granted CDI a US$1M Technology Development Grant and a US$1M Technology Development Loan.

The 3 patents in question are US Patent 5,843,780 (780 communication); 6, 200, 806 (806 communication); and 7, 029, 913 (communication forthcoming). The requests from FCTR were accompanied by the declaration of Jeanne F Loring, Adjunct Associate Professor at the Burnham Institute, and include references to prior art not considered at the time the patent was granted. This raises a "substantial new question" (SNQ) of patentability and grounds for a complete reexamination of the patent claims on the basis of prior art.

The requests also included reference to public harm, but the USPTO communication is clear that this is beyond the scope of reexamination. Nevertheless, John M Simpson, Stem Cell Project Director of FTCR, has welcomed the announcement and condemned WARF's patent policy, described in the press release as "WARF's aggressive assertion of patents." Simpson claims that WARF has "a history of putting profits before public benefit." An earlier press release quotes the Juvenile Diabetes Research Association (JDRF) as saying that WARF patents pose a "major inhibition to productive scientific research."

Should WARF really have a monopoly on the toolbox?

FTAs and Public Health

2006-10-04T13:22:00.000+01:00

The US and Dominican Republic have just missed the 1 October deadline for implementing the Central American Free Trade Agreement (CAFTA). US officials have rejected the most recent draft of the Dominican Republic implementation of the Agreement, on the grounds that the patent laws are insufficient.

Judit Rius Sanjuan, Staff Attorney for the Consumer Project on Technology (CPTech) has reported that according to government and private sector sources, more time is needed to negotiate issues on pharmaceutical patents (as well as other concerns, such as textile rules of origin). An informal extension to 1 November is now believed to be in place, although this is also unlikely to be met.

One of the areas of negotiation in the CAFTA is the protection to be provided by the Dominican Republic for data generated by drug originators for the purposes of marketing approval. Such data indicates the efficacy and safety of the drug, and is important for determining equivalence for generics subsequently entering the market. However, the protection would protect the data under "data exclusivity" provisions in the Agreement. Without marketing approval, a drug cannot enter the market (time on the market therefore running "against the clock" of the patent protection). The CAFTA requires participants to provide 5 years of data exclusivity from the date a pharmaceutical product is submitted for marketing approval (for agricultural chemicals, the period is even longer, at 10 years). These provisions would give originators somewhat extended protection against generics over and above that provided by patent protection, in what is arguably anti-competitive and contrary to innovation in drug development.

Another concern in the agreement is the relationship between patents and marketing approvals. In response to issues surrounding the implementation of the Agreement in Chile, the Pharmaceutical Research and Manufacturers of America (PhRMA) has argued that Chile is giving marketing approval to drugs that are copies of products still under patent. As a result, the United States Trade Representative (USTR) has commenced a Special 301 Out-of-Cycle Review of Chile to monitor its progress on intellectual property protection, citing as a major concern ongoing issues around data exclusivity and the protection of test data submitted by pharmaceutical companies during the approval process.

A recent debate in the Financial Times raises concerns about the impact of free trade deals on competition in the generic drugs market. The article, "Patent or patient?" by Alan Beattie, Andrew Jack, and Amy Kazmin, describes the congressional mandate and "fast-track" trade promotion authority behind "a US drive to strengthen patent enforcement and intellectual property rights protection around the world - a campaign backed by some of the powerful drugs companies." Noting the opposition from public health specialists, campaigners, and developing countries, the article questions the argument that patent protection will bolster innovation.

The authors consider the bilateral negotiations with Thailand and the similar requirements on data exclusivity in the Thailand agreement. In the article, the Deputy Director of Research and Development at Thailand's Government Pharmaceutical Organisation (GPO), Achara Eksaengsri, thinks the bilateral terms would have a highly detrimental impact on public health, particularly in treating HIV/AIDS.

Also in the article, Pedro Chequer, former head of Brazil's national AIDS programme, describes "intense lobbying" and "threats of direct retaliation" when Brazil declared it would issue a compulsory licence to produce Kaletra, a second-line AIDS treatment. Bilateral negotiations may weaken these flexibilities current available.

In a letter to the FT, responding to the article, Kathleen Jaeger, President and CEO of the Generic Pharmaceutical Association (GPhA), says, "The FTAs are establishing a lopsided global system of pharmaceutical IP rights." She goes on to say that this limits generic competition not only overseas, but also in the United States: "The USTR must not leave our healthcare system vulnerable to prolonged brand drug monopolies."

Meanwhile, in Europe, Peter Mandelson, Commissioner for External Trade, has rejected the proposal from Angela Merkel, German Chancellor, for a free-trade area between the EU and the United States. Mandelson argued that such a deal would "trigger an outcry" from the rest of the world.

Brazil Draft Resolution on Access to Medication

2006-10-03T16:36:00.000+01:00

Brazil tabled a draft resolution on access to medication today, at the Human Rights Council (HRC) in Geneva.

The newly established HRC is currently meeting in Geneva for its second session, 18 September to 6 October.

The resolution "requests the Secretary-General, based on consultations with Governments, United Nations organs, programmes, specialized agencies and international and non-governmental organizations, to conduct a study on the possible impacts of intellectual property rights on the access to medication," particularly in areas of extreme emergency, including HIV/AIDS, malaria, and tuberculosis. It is proposed that the results of the study would be presented as a report to the HRC at its 4th session.

Importantly, the resolution looks to the exploration of "new and innovative financing mechanisms," arguably relevant not only in the research and development of new medicines but also in the transfer of technology and the improvements to infrastructure and facilities in developing economies. On this point, the recent WHO report is evidence of the necessity to develop new frameworks for R & D and transfer. And a recent article in PLoS Medicine, by Michael Westerhaus and Arachu Castro, suggests that the WTO rules to improve global publich health have really achieved little change in the area of HIV/AIDS.

The HRC is set to consider the resolution this afternoon.

Thanks to Hossam Bahgat, Egyptian Initiative for Personal Rights (EIPR), for this information from Geneva.

WHO Plans Public Health Consultations

2006-10-02T20:36:00.000+01:00

The World Health Organization (WHO) is holding public consultations with stakeholders on global public health and intellectual property, and will stage the first meeting of the intergovernmental working group in early December.

In September, WHO established a secretariat on Public Health, Innovation, Essential Health Research and Intellectual Property to convene and facilitate an intergovernmental working group. The working group was requested by Member States in a Resolution adopted at the World Health Assembly (WHA) in May this year.

In a report in IP Watch, Tove Iren S Gerhardsen has spoken with Elil Renganathan, operational head of the project. Renganathan suggests that the December meeting will be like a "mini-World Health Assembly." The first consultations are planned for November, and will include non-governmental organisations (NGOs), academics, experts, and the members of the public.

In 2003, WHO set up the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), "Against the background of an ongoing international debate concerning the
relationship between intellectual property rights, innovation and public health, in
international organizations and more generally among governments and civil society
organizations" (CIPIH Report). In April this year, the CIPIH published the report, Public Health, Innovation and Intellectual Property Rights, analysing the interaction between these 3 critical areas. The report was considered by the intergovernmental working group of WHO's Executive Board, 28 April, and then by all member states (192 countries) at the 59th WHA, 22-27 May 2006.

At the 59th WHA, the Resolution on Public health, innovation, essential health research and intellectual property rights: towards a global strategy and plan of action, was adopted. The Resolution called for the establishment of the intergovernmental working group in order to devise a global strategy and plan of action. The intergovernmental working group and secretariat are to respond to the recommendations of the WHO Report.

The details of the meeting are likely to be announced by WHO mid to late October. IPmed will report the details.