The World Health Assembly, the policy-framing body that gives guidance to WHO on the views of member states and sets global health policy, has voted to support a resolution affirming that public health interests should remain paramount when framing policy on pharmaceuticals.
The implications of the resolution will alarm United States trade representatives, who have been fighting a rearguard action in the World Trade Organisation to defend the rights of pharmaceutical patent holders against compulsory licensing on public health grounds. At the November 2001 Doha WTO summit, it was agreed that the TRIPS agreement on intellectual property "can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all."
A major sticking point at Doha was the question of whether generic producers in countries like India should be allowed to export to countries with little or no manufacturing capacity on public health grounds, the so-called Paragraph 6 issue. Developing countries were promised a solution to this issue by the end of 2002, but it remains unresolved. The US has tried to limit the list of diseases that would eligible for such an exemption on public health grounds, and even though every member of the WTO voted against the US proposal, the European Union Trade Representative Pascal Lamy has subsequently proposed a similarly edited list as a `compromise`. In the meantime, compulsory licensing for diseases that everyone agrees on – HIV, malaria, TB and a handful of tropical diseases – remains blocked.
The resolution adopted by the World Health Assembly, despite vigorous US opposition to any WHO involvement in intellectual property issues, states that:
- Public health interests are paramount in both pharmaceutical and health policies
- Member states should consider, whenever necessary, adapting national legislation in order to use to the full the flexibilities contained in TRIPS
- WHO should support the exchange and transfer of technology
- WHO should produce an analysis of methods by which research and development of medicines for the developing world can be stimulated and financed, to report by January 2005
The resolution did not instruct WHO to give assistance to countries in identifying how to draft laws that would allow greater flexibility on TRIPS, and did not instruct WHO to intervene wherever necessary in trade negotiations that might restrict access to essential medicines.
However, a recent Medecins sans Frontieres report, Drug Patents Under the Spotlight, suggests that much work needs to be done to inform developing countries of their current options under the existing intellectual property regime. Although the TRIPS agreement has been portrayed as restrictive, the MSF report points out that countries can still decide what sort of inventions they will grant patents for. In countries without current patent provisions for pharmaceuticals, the framing of patent regulations could have a huge impact on the price of medicines and the ability of countries to issue compulsory licenses.
The subject of a patent must be new – the key flexibility on this issue is whether novelty is defined locally or globally. If a novel invention is defined globally, the Paris Convention for the Protection of Industrial Property gives an inventor 12 months to file patents worldwide before the novelty of an invention is considered to have expired. Patent offices could be more strict about applying this provision.
The inventiveness of the innovation should also be assessed – is it impossible for an expert to have anticipated this invention? European patent law states that “an invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art.”
MSF argues that anyone with a modicum of knowledge about HIV treatment could anticipate that a fixed dose combination of already known antiretrovirals is possible.
GlaxoSmithKline was granted a patent in 1991 for the idea of combining its drugs AZT and 3TC on the grounds that the combination delayed resistance. The patent is for the activity of the drugs when used in combination to prevent the emergence of AZT resistance rather than the chemistry needed to combine the two drugs in one pill, yet many people would argue that Glaxo’s discovery back in 1991 was serendipity, and that it could equally well have been observed by anyone with the opportunity to use the two drugs together.
Patents can also be granted for new uses of existing drugs. The TRIPS agreement does not specify when a new use should be patented, so it is up to individual countries to decide what to do. The UK Commission on Intellectual Property recommended that developing countries should not issue patents for new uses of existing drugs, of which zidovudine (AZT) is an example. Zidovudine was a cancer drug abandoned in the 1960s which was dusted off in the 1980s when it showed activity against HIV. Here it is arguable that anyone who had access to that compound could have discovered its activity against HIV. In fact, that's just what happened - although Wellcome owned the patent, the discovery of its anti-HIV effect was made by scientists working for the United States National Institutes of Health.
US courts dismissed a lawsuit challenging GlaxoSmithKline's patents on AZT, 3TC and abacavir last year, but this doesn't mean other countries would have to accept claims of novelty
In some circumstances countries can refuse patents. For example, TRIPS instructs that patent applications should provide enough information for any skilled person to replicate the invention. If a patent does not contain such information, it could be revoked or refused.
MSF also points out that patent information is difficult to obtain – governments and NGOs may not even know whether a drug is patented in their country, and may not have the technical skills to locate the patent.