Significant movement to fight against

Thank you for accepting to be interviewed by the UN Special on this timely and important issue.
One of the United Nations Millennium Development Goals (MDG) was to “Halt and begin to reverse the spread of HIV/AIDS”. In your opinion, two years later, is this on the right track? If yes, to what extent and in what areas: awareness, counselling services, prevention and/or treatment? After the Millennium Development Goals, there was a clear commitment by all the Member States to fight AIDS to reach specific targets in mother-to-child transmission, voluntary counseling, and in caring and support. In all those areas governments have moved very significantly. We have seen the emergence of the Global Fund against tuberculosis and malaria that has now supported significant number of countries with funds and pledges of funds in an unprecedented order of magnitude. We have seen the announcement of Bush’s administration in the United States, pledging $15 billion support for the fight against HIV. We have seen the World Bank presenting its multi country AIDS programme to allow access to treatment which is significant, because the AIDS programme is worth something like a billion dollars a year. So these are all significant moves. Of course, we will always prefer to see more action and we are all aware that in all these positive efforts that I have mentioned, question marks remain. We know, for example, that the Global Fund against AIDS, Tuberculosis and Malaria right now has difficulties finding the necessary resources, and skeptics doubt whether the appropriation bills for the Bush’s administration initiative to fight AIDS will make it through Congress in the United States. Also, the multi country AIDS programme could disburse its funds faster. But the bottom line is that there has been very significant movement to support the fight against HIV.

What are generic AIDS drug, and antiretroviral drugs?
When a company develops a new drug, it normally protects its invention against competitors by patenting it in all markets it regards as essential to remain competitive. However, this leaves the possibility for competing companies to market copies of that drug, or combinations of that drug with other drugs, in countries where the originator companies have requested no patent. These copies are called “generic drugs” and as patents typically expire after 20 years, these generic drugs do eventually also become available in the markets in which they could originally be marketed only by the originator company. Anti- retroviral drugs are drugs that are used for the treatment of HIV infection. HIV is a retrovirus, and that explains where the name of this class of medicines comes from. Today, there are almost 20 antiretroviral drugs in use.

Are these drugs used together or alternatively? Or does one replace the other? 
In antiretroviral treatment you always need to combine at least 3 drugs: two from one class, to which at least one additional drug from another drug class needs to be added. In the past this required some patients to take many – up to 16 – tablets a day. Fortunately, the pharmaceutical industry is doing a lot of effort to combine these drugs in fewer tablets, and today there are treatment regimens that require patients to take only 2 tablets a day.

How do doctors decide which treatment to use? Do they have a mechanism ?
The WHO regularly gives specific guidance on how these drugs should be combined. The latest recommendations have been published in April last year. The mechanism used to develop these recommendations is that WHO identifies the key experts in the antiretroviral treatment who develop the guidelines reflecting the state-of-the-art scientifically through a formal consultation process.

Who are the producers of these drugs?
The key producers are the companies, which developed these drugs. There are now 8 leading Research and Development (R & D) companies producing anti- retroviral drugs, with headquarters in the US, the UK, Germany and Switzerland. Generic antiretroviral are mainly produced in India, Brazil, Argentina and Spain.

Who are the buyers and what is the current cost per person per year?
Outside of industrialized countries where well-developed health systems and social security systems procure these drugs for their populations, it is mainly governments, NGOs and the private sector that buy these drugs. The cost per person per year varies according to the molecule that people use, the combinations that they use and the source of the drugs. The cost of first line treatment with antiretroviral can be as low as $260 per year in the least developed countries. In medium income countries the prices are higher and could be as high as $1000 per person per year and in industrialized countries these drugs cost $10 to 12 thousand dollars per year.

What is the role of the World Health Organization (WHO) and that of the World Trade Organization (WTO) in the selling and buying of these drugs?
The WHO does not buy or sell any of these drugs. With UNICEF, MSF and UNAIDS, we map out in an annual survey, where these drugs can be obtained and at what price, to inform decision makers at the country level. In addition to this mapping of the market place, we have two other pricing services. One is by the WHO Regional Office for Africa (AFRO) and one in collaboration with the WTO and UNCTAD. The last one is to survey the price levels of raw materials in the international market. Beyond this, WHO also pre-qualifies suppliers for the UN system. WHO is now consulting its partners on the development of a global facility to make AIDS drugs and diagnostics more widely available. The role of WTO is very important to bring about clarity in the rules and regulations that underline international trade. Following the declaration of the Doha Ministerial Summit, there have been discussions about intellectual property and access to medicines. Those discussions came to a successful close the week preceding the recent WTO Cancun Conference. The agreement covers all medicines, but preferentially, drugs to treat AIDS, tuberculosis and malaria. The challenge now is for member states to use the agreed flexibility in the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and the volume of the transaction for the sake of public health.

What are the crucial issues in this business transaction and at the same time a serious public health problem, one which is affecting over 42 million people worldwide 40 million in developing countries of which over 25 million have lost their lives so far?
In the business transaction, the critical issue is always demand and offer; this significantly determines pricing levels. It would be a fair assessment that today the demand for these drugs in developing countries is not well enough developed. The Director General of WHO is calling on all countries in the world, and especially in developing countries, to take energetic action to get three million people on treatment by the year 2005. The Organization trusts and hopes that they will heed his call because the lives of millions of people literally are at stake. On the side of the offer of these drugs, it is not sufficiently developed in the sense that the price level in particular of antiretroviral drugs is too high. This reflects to some extent the influence of the patent protection, but more importantly, the uncertainty that the companies face when they need to produce these drugs. There are uncertainties whether there will be a significant market for ARVs in developing countries. 

What is the responsibility of the WTO Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) when it comes to buying, selling and producing generic and anti-retroviral drugs?
Its main responsibility is to design and clarify the rules governing intellectual property rights related to trade. This also determines the extent of patent protection for drugs. This clarification of the rules governing access to drugs has gone forth now.

What is next on TRIPS?
What needs to be done now is for Member States to use the flexibility they have on TRIPS for access to drugs and for the protection of public health.

How does this new agreement change the life of an HIV/AIDS affected person?
It depends on how this new agreement will affect the behaviour of governments and of the pharmaceutical industry. It may well be that some of the pharmaceutical companies might in the future be more creative in their intellectual property policies, for the sake of avoiding conflicts with Member States; e.g. through the use of voluntary licensing.

Are generic drugs being produced in developing countries? If so, which ones? If not, why not?
Of course these drugs are being produced in developing countries. The leading producers include Brazil, India, Argentina, and several other countries. Korea and China are important sources of raw materials. I read in one of the Médicins Sans Frontières (MSF) papers prepared for a conference, “Countries such as Brazil and Thailand have succeeded in pushing the price of HIV/AIDS medicines down not by securing mark- downs from pharmaceutical companies, but by producing cheap generic equivalent of potential antiretroviral drugs locally”. If that is possible, could WHO assist in transferring these expertise and technologies from such countries to other developing countries, which are severely affected by HIV/AIDS? Hence, it can continue to push down the prices of generic drugs to an affordable level and reduce the pressure on the already limited social services of developing countries.

I don’t know whether this will be a possibility. Thailand and Brazil, which are developing countries producing anti- retroviral drugs, have offered their technology to other developing countries for the sake of expanding access to treatment of HIV infection.

What about the pharmaceutical companies that we hear a lot about in relation to generic drugs. What is the significant role of the companies? Are they negotiating on behalf of their companies or are member states negotiating on their behalf? Sometimes it gets confusing who is representing whom. 

Pharmaceutical companies are commercial entities. They produce drugs and make them available for the buyers. They negotiate on their own behalf and individually. At times, distributors or representatives represent them in negotiations, but they always act on their own behalf.

What is WHO’s future strategy for generic drugs for developing countries?
As part of its medicines strategy, WHO seeks to ensure that all people who need access to essential drugs can get them. The role of the generic pharmaceutical industry is acknowledged in our medicines strategy, but we have no separate strategy to push generic drugs, as we recognize the need for innovation. Hence, the capital role of the R & D pharmaceutical industry is in innovation and the role of intellectual property to protect it. But, as far as I know, WHO has not played a significant role in this area.

You know very well that most of the HIV/AIDS patients around the world do not understand the legal implications and complications of international business laws, which are forbidding them from getting the cheapest medicine for their illness.

What is the mechanism that WHO uses to reach out to HIV/AIDS affected people in different countries to inform them on new developments, such as the legal changes to enable them to import cheaper generic drugs?
WHO works primarily with Governments and also with Civil Society leaders in the health sector. It uses its contacts with these entities, its publications, and its web presence to reach out to other constituencies. Specific initiatives to reach out to the HIV infected people in developing countries include our support to the International Treatment Access Coalition (ITAC), in which over 120 partners collaborate to support HIV treatment access.

Interview by Seble Demeke, UN.