May 11, 2002

Accelerating Access: serving pharmaceutical companies and corrupting health systems
[French version at http://www.actupp.org/article498.html]

May 11, 2002 marked the second anniversary of the "Accelerating Access" initiative, launched by UNAIDS in a partnership with several UN agencies (WHO, FNUAP, UNICEF and the World Bank) and five pharmaceutical companies (Boehringer Ingelheim, Bristol-Myers Squibb, Glaxo SmithKline, Merck & Co., and Hoffman-La Roche [1] ). Since the end of 2001 this initiative has been under the responsibility of the WHO.

According to the UN, Accelerating Access means "a redoubling of the efforts of the cosponsors and the UNAIDS Secretariat to finance health care for people living with HIV/AIDS." This initiative was supposed to provide developing countries with access to medicine at the lowest possible prices, as well as provide technical support for the implementation of national access programs for antiretroviral treatment.

Two years later, people with aids examine the results. Accelerating Access serves, above all, pharmaceutical companies who profit from a partnership with international institutions while using the program to keep their monopolies and to limit any reductions in price.

According to the most optimistic of estimates, after two years Accelerating Access has only resulted in getting an additional 0.1% of people with aids on treatment (indeed, WHO rates at 10 million the number of people requiring immediate antiretroviral theraopy). Further, many of these treatments are actually based dangerous drug regimens—such as single-drug therapy, which has been banned from Northern medical practice for the last 10 years.

********* Why such bad results? *********

Because the pharmaceutical companies involved have mostly been busy negotiating agreements with developing countries that allow them to control the supply of ARVs and to stave off competition from generic makers. The companies' core strategy revolves around limiting price drops and imposing access restriction on developing countries.

Accelerating Access fails to offer any real progress in terms of price in the sense that because the proprietary pharmaceutical corporations have been content to just align their prices with those of the generics producers. But more significantly, their philanthropic discounts have systematically come with strings attached: discounts restricted to very specific drugs, quantities, countries, distribution sectors and medical settings, as well as tied to government commitments to increasing patent protection and not resorting to generic competition.

Far different from commercial, blanket price reductions, AAI discounts are philanthropic actions accompanied the signing of an agreement between each company and the health minister, setting convoluted conditions under which the reductions are applicable (governments are usually required to keep these agreements entirely secret and leave all media communication to the company).

Moreover, AAI has completely failed to create significant price discounts for the drugs that have no generic competitor yet. For example, Swiss drug giant Roche continues to sell its leading protease inhibitor Viracept® for an astounding USD 3139 a year through Accelerating Access.

Because the WHO and UNAIDS have not provided any assistance to countries to enable them to launch or expand treatment access programs. Many countries have taken on the Accelerating Access offer and have still to receive, two years later, any technical assistance from WHO or UNAIDS, or to show a single treatment access program for their trouble (Togo, Congo, Burkina Faso, etc.). Also, no specific aid has been put into place by these agencies to ensure the quality and sustainability of AAI-mediated ARV provision.

Because the WHO and UNAIDS have proved unable to ensure that negotiations be transparent, respect basic ethical standards and eventually achieve results. There are no guidelines for relations between companies and developing countries. In each case so far, pharmaceutical companies have taken their negotiations directly to the government or to the providers of health services, country by country, each in an independent way, without any supervision by UN agencies. This means that the Accelerating Access label is attached to‹and serves as a guarantee for‹negotiations that the WHO and UNAIDS have no power over and cannot even really follow up on. Because by only including proprietary pharmaceutical companies, United Nations agencies have pushed aside the producers of generics and trapped developing countries in unequal negotiations. Generic competition [2], the only sustainable way to get low prices, has been pushed aside in favor of subjecting countries to the goodwill and demands of multinationals.

********* Countless negative consequences*********

But, after two years, Accelerating Access has more to show for itself than just bad results in terms of medicines provided and lives saved. This initiative is responsible for numerous negative consequences that the WHO and UNAIDS have not only been incapable of stopping but that they have even supported. These include instrumentalisation of international health institutions, discrimination between recipient countries, market fixing, short-circuiting national drug circulation systems, and spurring irrational, dangerous prescriptions.

1. The WHO label, marketing added value for pharmaceutical companies

For two years Roche Pharmaceuticals has bragged about its participation in the Accelerating Access initiative and of its work facilitating access to treatments in developing countries, while in fact Roche has so far refused to grant price discounts on its products. There are no generic competitors for Roche's HIV products, which means it is not forced to reduce its prices. At the end of April, Mr Nabarro, Executive Director of the WHO, acknowledged that he "had problems with some companies" and "wished Roche would start to play by the rules" as soon as possible.

2. Accelerating Access: a tool that discriminates among poor countries

Apart from the fact that WHO's Accelerating Access Initiative concerns not multilateral (like WHO) but bilateral negotiations (one country at a time, one drug at a time, precluding regional, purchasing-power negotiations), it discriminates between developing countries in terms of the extent of price of price discounts arrived at through the "negotiations".

Thus in poor countries considered "too rich", such as Morocco or Thailand, drug firms refuse to grant the same reductions as in sub-Saharan Africa. Yet no one ignores that in Morocco and in Thailand people are already poor enough that every dollar added to the price deprives many of those lifesaving medicines. Further, pharmaceutical companies feel free to threaten countries with calling the discount deal off should find out that the government is buying from generic producers (Thailand).

3. Captive markets

After the defeat of pharmaceutical companies in South Africa in spring 2001, drug companies stepped up their efforts to recruit developing countries to Accelerating Access and thus impose themselves, their power and their vision of intellectual property on these countries. The consequences are plain to see. Despite the immediate advantages that it represents for them (lower prices, no stings attached), very few countries have dared to turn to generics. In Burkina Faso, the international summit on access to generics, which should have taken place in the capital from May 3-7 2001, was canceled after the minister of health signed an price discount accord with some of the pharmaceutical companies.

Indeed, through Accelerating Access companies force countries to sign confidential agreements that seek to ensure their continued monopoly by by hindering resort to generics. These include intellectual property clauses which impose restrictions stronger than those mandated by the World Trade Organization ("TRIPS+") as well as renewed purchase commitments over several years (BMS, Merck). Thus, even countries which have no legislation on intellectual property are forced to buy all their antiretrovirals from proprietary multinationals.

In certain countries, in order to access cheaper medicines, people with aids have to buy generic medicines imported by NGOs (MSF in Cameroon, ANSS in Burundi, etc) rather than from the AAI providers. The control of medicine circulation, which should have been centralized by the government and which Accelerating Access is supposed to guarantee, is, in fact, nonexistent.

4. Corrupting national procurement networks

Since it was created, Accelerating Access has operated in parallel to national health care systems. Right now, this initiative bypasses official procurement networks. For years WHO has been promoting the creation of central purchasing offices on a national scale, which work on the basis of transparent public tender. Today, however, WHO supports the signing of contracts between Ministries of Health and pharmaceutical companies on the sale of medicines that create a system of procurement parallel to that of national pharmacies, a lack of transparency with regards to prices, no competitive bidding and thus no competition. The pharmaceutical industry thus bypasses public procurement systems, increases its power over a few officials or doctors as well the opportunities for corruption by setting up a totally opaque system.

5. Irrational and Dangerous prescriptions and drug uses

Since Accelerating Access only includes a reduced number of pharamaceutical companies and price reductions only apply to certain medicines, this means that the entire therapeutic palette necessary to treat aids patients is not available. Even though one of the prerequisities for countries' participation in Accelerating Access is supposed to be the guarantee of a "secure, efficient system of distribution," in reality this initiative has caused irrational prescriptions that are based on economic imperatives‹a choice of medicines based on the discounts granted by industry. What follows are prescriptions for therapeutic combinations that are inefficient and even dangerous in terms of their side effects, all under the name of clinical trials or treatment access programs.

Certain companies, playing on their influence over doctors, push them to prescribe completely bizarre therapeutic combinations. In Kenya, Merck & Co. promote a bitherapy including two of its medicines‹indinavir (Crixivan®) and efavirenz (Stocrin® or Sustiva®) — a risky combination since efavirenz requires a higher dose of indinavir which itself requires higher levels of hydration and increases the risk of renal toxicity. In South Africa, BMS continues to promote the prescription of its three medicines ddI, d4T and hydroxyurée, a combination that researchers have shown to be potentially dangerous.

Accelerating Access is a striking example of a dishonest compromise between international institutions and the pharmaceutical industry at the expense of people and public health.

The WHO must not allow developing countries to enter into agreements with private companies unless they can guarantee transparent negotiations that respect basic ethical standards and provide some results.

The WHO must change its strategy immediately.

For the price of medicines to really be affordable, several measures must be taken: -the developing of international and regional purchasing of medicines [3], on a large scale that will allow for the best price negotiations; -the reinforcement of capacities and technology transfer in order to promote local drug production in developing countries; -compulsory licensing and parallel imports; - competition between brand-name medicines and generics.

Access to generics is a major issue for developing countries and the only long-term option for access to the largest and most complete variety of treatments at the lowest prices.

The WHO must provide countries with the most complete information possible on the sources of medicines, naturally and necessarily including generic producers.

It is particularly necessary for public central buying offices and any other potential users to have access to unbiased information on the prices of ARVs.

The WHO must support the development of bulk purchases of medicines for countries at the lowest price, as well as local production.

The WHO must provide countries that wish to set up treatment access programs with genuine technical help.

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Appendix I : List of countries involved in Accelerating Access (March 22, 2002)

Countries having signed an agreement with pharmaceutical companies: Benin, Burkina Faso, Burundi, Cameroon, Congo, Cote d'Ivoire, Gabon, Mali, Morocco, Rwanda, Senegal, Uganda, Barbados, Chile, Honduras, Jamaica, Trinidad and Tobago, Romania. Countries in the process of negotiation as of last March: Botswana, Republic of Central Africa, Chad, Ethiopia, Gambia, Guinea, Kenya, Malawi, Nigeria, Swaziland, Togo, Tunisia, Guatemala, El Salvador, Mexico, Venezuela, Ukraine, Vietnam.

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Notes: 1 — Later, Abbott and Pfizer also joined the initiative.

2—In 2000, the production of generic antiretrovirals in some developing countries (India, Thailand, Brazil) drastically lowered the prices of these drugs. In October 2000 an Indian producer launched a generic tritherapy for 800 US dollars per year, a reduction of more than 90% compared to the prices of multinational corporations. In February 2001 the price offered by this company dropped to 350 US dollars. In October 2001 another producer's price was reduced to 295 US dollars. The marketing of such low-cost generic drugs quickly forced western companies to adjust their own prices to match those of generic producers. Until then, they had refused to grant important reductions to developing countries, despite the entreaties of UN agencies. The marketing of generic antiretrovirals proved two things: -that medicines can be sold at prices considerably lower than what the drug industry had previously claimed - that the absence of a monopoly and competition among producers are the most efficient ways to obtain a drastic and lasting reduction in the price of medicines, much more efficient than so-called philanthropy or charitable work of pharmaceutical firms.

3- Such as the system operated by UNICEF to supply vaccines and contraceptives.

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