Patents and medicines: The WTO must act now!

The following is the text of a joint NGO statement on the Special Discussion in the WTO TRIPS Council on patents and access to affordable medicines. The statement was endorsed by over 100 NGOs and issued in Geneva on 19 June at a media conference organised by Oxfam, Medecins Sans Frontieres and Third World Network.

THE deepening health crisis in many developing countries has raised public concern about the lack of access of poor people to affordable medicines. Public outrage over the exorbitant prices of HIV/AIDS drugs has also put the spotlight on the negative effects of global patent rules on the price and affordability of essential and vitally needed medicines. Each year about 11 million people die from preventable infectious diseases. The AIDS epidemic is claiming millions of lives, to the extent that in some countries over a quarter of the population is affected.

Around the world, public concern is mounting at how the introduction of strict patent regimes in developing countries required by the WTO’s TRIPS Agreement is causing the price of patented drugs to be set at high, often exorbitant, levels. The effective monopolies granted by TRIPS allow pharmaceutical giants to suppress competition from alternative, low-cost producers and to charge prices far above what is reasonable. This is done at the expense of many ordinary consumers who are too poor to afford treatment.

Before the establishment of the TRIPS Agreement in 1994, countries were allowed more options to exclude sectors from patent rules in their national laws. Approximately 50 countries (both developed and developing) excluded pharmaceutical products from patenting. However, with the implementation of the TRIPS Agreement, member countries are no longer allowed to do this.

The Agreement does allow member countries to take compensatory measures to counter the effective monopolies of companies owning patents. Two of the most important measures are the issuing of compulsory licences, whereby a government can give permission to other parties to produce or import products on which patents had been given without the permission of the patent holder, and the practice of parallel imports. Since TRIPS does not limit the grounds on which compulsory licences can be given, a country should not be prevented from issuing compulsory licenses on other grounds that it may consider necessary to meet public health and other public interest objectives.

However, pressures have been put on many developing countries by governments and companies in some developed countries not to exercise their rights to compulsory licensing or parallel importation. Recent examples of harassment faced by developing countries include the case brought by 39 pharmaceutical companies against the South African government over its Medicines and Related Substances Control Amendment Act, and the dispute settlement case lodged by the USA against Brazil in the WTO in relation to its Industrial Property Law. People everywhere, in developing and developed countries, are outraged at these kinds of pressures imposed on poor countries to prevent them from using the flexibility of TRIPS to improve the access of ordinary people, particularly the poorest, to medicines.

Growing public reaction to the scandal of patents and high medicine prices provides the background to a one-day Special Discussion on patents and access to medicines, which will be held by the TRIPS Council at the WTO in Geneva on 20 June. This Special Discussion was proposed by the Africa Group of countries in the WTO and supported by many others.

We, the undersigned NGOs, welcome this decision and regard the Special Discussion as an important opportunity for the urgent consideration and resolution of the negative impacts of the TRIPS Agreement on health and access to medicines.

In agreeing to the Special Discussion, WTO member countries have taken the first step towards clarifying the role of intellectual property rights and interpreting the TRIPS Agreement in such a way that intellectual property protection does not hinder access to vitally needed medicines. This meeting represents an opportunity to shift the balance of global patent rules in favour of the public interest and the protection of public health.

In developing countries, the TRIPS Agreement has exacerbated conflicts between private corporate interests and the public interest including public health. The controversy over access to medicines has highlighted just one aspect of the imbalances within the TRIPS Agreement, which is too heavily tilted in favour of private right holders and against the public interest. There is growing evidence of social and economic problems caused by the introduction and enforcement of stricter intellectual property rights, which developing countries are obliged to implement as part of their obligations under TRIPS. This has resulted in calls for a re-assessment of the Agreement itself.

The key principle that should guide the discussions in the WTO is that access to essential and vitally needed medicines is a fundamental human right. Poor people have the right to good health, and therefore to medicines for the treatment of poverty-related diseases. Protecting people’s health and saving their lives must take precedence over the strict protection of intellectual property and the very high profits which drug companies derive from this. Governments need a permanent guarantee that they can put public health and the welfare of their citizens before patent rights, without having to face the kind of legal pressures or threat of trade sanctions experienced by South Africa and Brazil.

We therefore call on WTO member countries, during the Special Discussion, to:

·        Strengthen the existing public-health safeguards within TRIPS to ensure that governments have the unambiguous right to override patents in the interests of public health;

·        Adopt a pro-public health interpretation of the Agreement through the flexible use of existing safeguards and exceptions. These include upholding the right of countries to grant compulsory licences for local manufacturing, import and export, and their right to implement parallel importation measures;

·        Remove the burdensome conditions that governments have to fulfil in the issuing of compulsory licences, so that licences can be granted on a ‘fast-track’ basis for public-health purposes;

·        Extend the implementation deadlines within TRIPS for developing countries in relation to patent protection (both product and process) for medicines;

·        Agree not to exert bilateral or regional pressure on developing countries which take measures to exercise their rights under TRIPS to protect public health and promote access to medicines, nor to pressure them to implement unnecessarily strict and potentially harmful intellectual property protection standards or ‘TRIPS-plus’ measures;

·        Observe, with immediate effect, a moratorium on dispute settlement action against developing countries which hinders their ability to promote access to medicines and protect public health (including the use of compulsory licence and parallel importation measures);

·        Allow developing countries the option of excluding medicines from patenting on humanitarian or public-health grounds, in order to meet the objectives of saving lives, countering and controlling epidemics, and ensuring that the poor obtain access to essential medicines for the treatment of poverty-related diseases.

The NGOs signing this statement will use the above recommendations as the yardstick to judge the decisions and actions taken by the WTO TRIPS Council and higher bodies of the WTO, and whether the process initiated by the Special Discussion on TRIPS and medicines has been a success or a failure.

People all over the world will be watching whether WTO member countries meet the challenge of tackling the global health crisis, and demonstrate their commitment and contribution to the prevention of further unnecessary deaths.

We also call on governments in developed countries not to be influenced by any attempts by multinational drug companies to block clarifications of, or changes to, the TRIPS Agreement which are needed to make medicines affordable to the poor. We also call on the governments of developing countries to stand firm in putting forward proposals that affirm and strengthen their rights under TRIPS (especially in relation to compulsory licensing and parallel importation). Discussions on schemes such as ‘differential pricing’, or a global fund for AIDS, should not distract from, or be a substitute for, the need for action on patents and the TRIPS Agreement.

As of 15 August, this statement has been signed and endorsed by 164 organisations and 32 individuals. The full list of signatories can be found on the Third World Network’s website, www.twnside.org.sg.