Distinguished partners in development,

You are here to discuss rights. The right to ownership and the right to care. This discussion obviously cannot be isolated from the broader human rights and development debate. All aspects of human rights, including economic and social rights, are increasingly considered to be central to international law and international relations. Key themes in development, such as good governance and poverty eradication, are integral parts of a rights-based framework that challenges international organisations, states and civil society.

In his last address to the Commission on Human Rights, the UN Secretary-General underscored the need to bridge the gap between rights and realities, and called for new momentum to the struggle to place development at the service of human rights and human rights at the centre of development.

Your topic, patent rights versus patient rights, must be seen in this perspective. Patient rights are very closely associated with human rights in this context. The question is therefore: can patent rights contribute to development that is at the service of human rights?

The 22-year-old Health for All strategy from Alma Ata, Health for All by the Year 2000, was built on two main pillars: empowering people to promote health and access to acceptable and affordable services relevant to people’s needs. We are now in the year 2000, but we cannot boast about our overall achievement. Rather, we have learned a lot about the obstacles for making the agreed right to health real.

It is obviously not my task in an opening statement to address this theme in all its complexity. But I would like to make some observations on two elements that will be central in your discussion of drugs and rights: access and price.

Access to essential drugs is one of several elements of an effective, equitable and just health policy. But it is a crucial element. The holders of rights are individuals, including the weakest and the most vulnerable. The duty to make sure that people can exercise the rights lies primarily with governments. But government options are regulated by interests and legislation that transcend national borders and are outside direct government control. Nor does disease respect borders. There are important health threats that cannot be controlled by national intervention alone.

Controlling disease through cost-effective interventions, including access to drugs and vaccines, is therefore high on the international public health agenda. This is motivated by shared interests and by the fact that ensuring access to essential drugs in the poorest countries will for a long time to come probably be a task beyond the capacity of individual governments acting on their own.

As regards both the financing and the provision of drugs, aid agencies and various non-governmental and private actors are therefore important stakeholders, both at the national and the international level.

Already at this point, before discussing national legislation and international agreements, we see the need to link national and international responses to the issue of access to essential drugs.

Access to a drug means that the drug is within the public domain, that it is of a high quality and that it is for sale on the market. There needs to be a dependable distribution system and measures in place for ensuring that the drug is used correctly. Access to essential drugs obviously also means that the drug has been invented or discovered. The system must therefore provide incentives to ensure that new drugs are invented, for the benefit of all.

At the same time, the patient (or the service delivery system) must be able to pay for the drug. The price to be paid, including the mechanism for setting a fair price and providing a reasonable incentive to the producer and the care provider, is therefore a key issue in drug policy.

The traditional system for providing the necessary incentives for developing new drugs has been by granting patent protection to the inventor. While the inventor acquires an exclusive right to exclude others from using or producing the invention for a limited period of time, the invention is made public – or accessible – and can be used as a basis for further research and development. When the protection period expires the invention enters the public domain, and can be copied by anyone. Patent rights thus give the inventor an opportunity to recover the cost of research and development, as he has a kind of monopoly on the product for a period of time. Without patent protection, anyone could copy the product free of charge.

Patent protection of drugs is now being given particular attention in the global debate on HIV/AIDS. Because AIDS is a relatively new disease, all drugs developed to combat it are still protected by patents. The protection prohibits other companies, for instance local companies in developing countries, from manufacturing the drugs without a licence from the patent-holder.

The worrying aspect of this is that the exclusive right granted by patent protection results in a lack of competition, which allows higher prices. This adds to the problem that for the majority of HIV-positive people who live in the poor countries of sub-Saharan Africa drugs to combat AIDS are too expensive or inaccessible.

Patent rights are meant to create a balance between the legitimate interest of the inventor and that of society at large. It has so far been considered the best system for ensuring access to existing and new inventions. I do not think that we can do away with this system. The question for you, I believe, is whether it can be modified for essential drugs in order to force prices down. Shorter protection periods for such drugs or the granting of compulsory licences to producers in developing countries are some of the solutions I know have been proposed, but I am sure that there are also other approaches that you will be discussing in the days to come.

Rules on intellectual property, including patents, are in principle national and determined by national law. Some have advocated that developing countries should not grant patents under their national legislation. However, the inclusion of the TRIPS agreement in the WTO has meant that for a great many countries patent protection is governed by this agreement.

For developing countries the implementation of the agreement only began this year, and for the least developed countries there is still an additional period of time before the agreement has to be implemented. It is therefore too early to make any accurate assessment of how it will function. What we do know is that there is clearly a need to examine how serious negative effects can be counteracted, such as in the case of essential drugs.

I mentioned compulsory licensing. The TRIPS agreement contains such an exemption from the exclusive right of the patent-holder. While the exact scope of the provision is still unclear and needs to be further interpreted and negotiated, compulsory licensing in accordance with the TRIPS agreement could in many instances provide a way for developing countries to obtain access to essential drugs at more reasonable prices. As stated in article 31 of the TRIPS agreement, "adequate remuneration" is to be paid to the patent-holder. Adequate in this context could arguably be well below the market price.

With regard to the future review of the TRIPS agreement, several countries have indicated that access to essential drugs is an issue they want to include specifically in the agreement. Such a possibility should be fully explored. A redrafting of the provisions on compulsory licensing could thereby provide an option where patent rights could be placed at the service of patient rights. I know that many of you are following this discussion very closely now in the preparations for the Geneva 2000 follow up to the Social Summit, as this is an agenda item on which there is so far no agreement. We appreciate your watchfulness and your contributions to this process.

Alternative solutions that do not just look at patent rights but at manufacturing and sales as a whole have also proved beneficial in terms of price. Spurred on by public pressure under an initiative brokered by the United Nations, five of the largest international pharmaceutical companies have agreed to cut the prices of their AIDS drugs for Africa and other developing countries. The plan could lead to overall price reductions of 70 per cent. Thus public pressure has led to pharmaceutical companies having to take concerns other than merely profit into consideration when setting the price of drugs for developing countries.

Somewhat along the same lines, new partnerships between the corporate sector, NGOs and researchers, individuals, governments and international organisations have now emerged with the aim of acting in concert to create win-win scenarios. This applies to research and development for new drugs and vaccines, and to funding the purchase of such new drugs and vaccines in countries that need this assistance. The Global Alliance for Vaccines is one such initiative.

I hope the next few days will witness an interesting discussion on the relationship between patent rights and patient rights, and one that looks not only at possible sources of conflict but also at possible solutions. Let us remember that patient rights, in terms of access to drugs, are concerned with much more than overcoming the price barrier and dealing with patent rights. This is even more important in the case of access to health care and the right to health.

The debate you will be conducting is in any case very central. All the parties concerned have legitimate interests that need to be recognised. Solutions, or lack of them, will have a significant impact on very many peoples’ lives. Lack of access to drugs, or lack of incentives to develop new drugs, will have a detrimental effect for all of us. Providing a more thorough analysis and clarifying interests, options and positions is therefore extremely important.

I wish you the very best in your endeavours, and look forward to being briefed on the findings from the workshop.