Monday, January 26, 2009

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

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 Draft 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.

Sunday, January 25, 2009

US Approves Embryonic Stem Cell Research Trials

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."

Saturday, January 24, 2009

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."

Tuesday, October 14, 2008

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

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.

Monday, October 13, 2008

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.

Sunday, October 12, 2008

The Wellcome Trust Book Prize

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.

Thursday, August 28, 2008

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.