Oxfam / HAI criticise EU for threatening access to medicines

Oxfam and Health Action International issued a report in late October 2009 which alleged that the European Union was contradicting world trade rules by pandering to the interests of Big Pharma ahead of the needs of people in less developed countries to gain access to essential medicines. The report, Trading Away Access to Medicines: How the European Union's trade agenda has taken a wrong turn, argues that the EU has become guilty of double standards. It notes that the EU Member States and the European Commission have taken steps to improve access to health services in developing countries, and has acted to reduce the price of medicines within the borders of the EU, but argues that the EU now has a trade agenda which acts directly against these same objectives in developing countries. The report claims that the EU is pushing for a range of intellectual property measures that would support the commercial interests of the pharmaceutical industry whilst damaging the opportunities for innovation and access to medicines in developing countries. The report goes so far as to say that the EU's demands exceed those pursued by the Bush administration in the United States, whose intellectual property policies were criticised for their detrimental effect on developing countries.

In the report, the two organisations urge that the EU adopt a number of positions, including honouring commitments under the Millennium Development Goals, the Doha Declaration on TRIPS and World Health Assembly resolutions on innovation and access to medicines; and ensuring that its trade policy is in line with its development objectives, particularly with regard to access to healthcare and medicines. With regard to intellectual property, the EU should not misuse free trade agreements in order to implement TRIPS-plus rules which place conditions beyond the scope of the TRIPS agreement and its application to medicines in order to extend monopoly protection and limit access to medicines. The EC should stop exerting pressure on governments that attempt to introduce safeguards to protect and promote public health; and should amend its counterfeiting regulation to ensure that it does not have a detrimental impact on developing countries. The EU should also ensure that the Anti-Counterfeiting Trade Agreement (ACTA) does not set a new global standard for intellectual property rules that will impede access to medicines for developing countries; and should identify and support measures to improve access to generic medicines in developing countries, including the UNITAID patent pool for HIV / AIDS drugs.

The report also urges the EU that with respect to research and development, European donors should scale up financial contributions to R&D to address diseases that disproportionately affect people living in developing countries. The EU should also support Product Development Partnerships designed to deliver affordable and effective new products, and should continue building R&D capacity in developing countries. It should also support the implementation of the WHO's Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, and support the Expert Working Group in its efforts to find new models of innovation. Finally, the EC should take measures to ensure that specific initiatives meet real health needs, and that the EU's regulations on children's medicines can also be to the benefit of developing countries.

As can be seen, the report has a long list of recommendations, and many of them are not new for Oxfam. In the past, however, many of these allegations, such as those regarding TRIPS-plus free trade agreements, have been labelled at the US, and it is interesting that this has now changed. Whether the EU will be any more willing to adopt these recommendations than the US is unlikely. However, there is no doubt that groups such as Oxfam will not stop pushing for change.

Ian Platts, Editor, World Generic Markets

Of patent pools and regime change

The growing impetus to amend Canada's Access to Medicines Regime (CAMR) has gathered pace, with Canadian Senate committee hearings into Bill S-232, which aims to streamline the regime, now underway. The hearings' opening statements have thrown up an interesting question over whether or not the existing act has actually failed. Critics – of which there are many – of CAMR in its current guise argue that the regime has clearly failed, pointing to the fact that in the five years in which the act has been in law, only one company has been able to use it. That company was Apotex, which used the act to provide a very limited run of antiretrovirals to Rwanda, in two shipments in September 2008 and September 2009. In total, around 14 million doses of a fixed-dose combination product were shipped. However, Apotex has been very vocal about the difficulties the regime produced, and has added that it would not use the process again in its current form, throwing its weight behind efforts to amend CAMR, with the added carrot that it would use an amended regime to produce paediatric antiretrovirals. However, on the other side of the fence, supporters of the current regime point out that it has been used successfully, even if only once. Furthermore, in doing so, this is the only such access to medicines legislation in the world that has worked. The Senate committee asked the question what reasons are behind the regime being so little used. The difficulties in using the regime are certainly one possible answer, and another possibility is that Canadian manufacturers simply cannot compete on price with, for example, Indian or Chinese manufacturers. A further possibility raised in the hearings' opening was that other factors have played a part, particularly the Global Fund to Fight HIV/AIDS, which has provided funds of some US$16 billion. The issue that Canada will need to decide is should CAMR be amended, and if it is, will this make a difference globally?

Another possible route for increasing access to essential medicines is that of developing a patent pool, an idea which also saw a boost recently, with the UK's government indicating support for this measure. The basic aim of a patent pool is that all the patents for essential medicines are made available collectively, enabling generic firms to use them to produce drugs for developing countries, paying the patent owners royalty rates in return. UNITAID has decided in principle to establish a voluntary patent pool for medicines in a decision made in July 2008, but it is a scheme that appears to have gained little traction since. However, in a speech on 12th October 2009, the UK Minister for International Development, Mike Foster, said that the UK government supported UNITAID's efforts, according to Knowledge Ecology International. Mr Foster's comments came a few weeks after Médecins Sans Frontières launched an email campaign targeting nine brand name companies, which between them hold patents for 21 antiretrovirals.

Both of these initiatives are efforts to crack the same problem. However, it is worth bearing in mind that these are not the only options. The branded companies themselves have also made efforts to provide essential medicines to developing countries, providing drugs at cost, or even donating them. Cynics may argue that this is little more than window-dressing, maintaining good public relations, and indeed may well be right, but it does surely reflect an expectation, seen in all these efforts, that developing countries need to be given every option to access essential medicines in order to save the lives of millions.

Ian Platts – Editor, World Generic Markets