Constitution for the NHS

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."

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

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.

SA Medicines Bill Approved Amid Widespread Condemnation

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:

1. public health interests;
2. economic interests in relation to health policies;
3. strategic interests in relation to health policies;
4. the need and desirability for such produch; and
5. 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

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.

Rising Drug Prices - The Real Devil in the Detail

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

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

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).

WHO Bulletin - Special Issue on Ethics and Public Health

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

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

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

[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

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

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

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 the 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."

Access to Medicine Ongoing Challenge for Poor

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?

WHO Public Hearing - Engaging the Private for Urgent Public Good

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.

EU Council Adopts EC Regulation on Paediatric Medicines

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.

FTAs - A Threat to Public Health

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 Health 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.

WTO - Update on Article 31bis

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).

Brazil Draft Resolution on Access to Medication

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.