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."