The Dutch authorities are reported to be planning prosecutions of people involved in importing antiretroviral drugs, supplied at steep discounts for use in African countries, which have been offered for sale to health care providers in the Netherlands, Germany, and the UK. Wholesalers are allowed to make 'parallel imports' of drugs from one EU country to another, but not to import EU-produced drugs from outside the EU. It is unlikely that any of the European purchasers of the drugs would have been aware of their intended recipients.
According to the Financial Times, the scale of this illegal trade appears to have been massive, amounting in the last year to nearly $18 million US dollars at European retail prices, and including one quarter of the total supply of Combivir provided by GlaxoSmithKline for use in African countries. Countries where the racketeers appear to have been operating include Congo (Brazzaville), Guinea-Bissau, Ivory Coast, Senegal and Togo. It seems that shipments from GSK in France were diverted by the traders on arrival at African airports and re-imported into Europe through Paris and Brussels.
GSK, the Anglo-American pharmaceuticals group which is the leading producer of ARVs, said: "We are appalled to see that this is occuring illegally and depriving treatment for the people in Africa for whom they were intended."
Pharmaceutical companies have expressed anxiety in the past about the possible `leakage` of discounted antiretrovirals back into the European and North American markets.
GSK said it remained committed to its scheme of providing lower priced drugs for AIDS and other major diseases in Africa and was co-operating with the authorities in the Netherlands and Germany.
The Dutch Health Supervisory Service said it would recall 3,600 packets of GSK's Combivir and 2,400 packets of Epivir, both of which sell for about €400 per 60-pill packet.
Uganda clamps down on local racket
According to New Vision in Kampala, Uganda (reports dated 24 September, 27 September and 2 October) the authorities in Uganda have recently arrested and are prosecuting at least 14 people allegedly caught re-selling the antifungal fluconazole (Diflucan). The National Drug Authority has withdrawn the licenses for ten of the pharmacies involved. These drugs had been provided by Pfizer through a donation programme for people with HIV to whom it was supposed to be provided free of charge, on prescription to treat cryptococcal meningitis or oesophageal candidiasis. The Pfizer programme is still being expanded and includes training for health care workers. While initially set up as a five-year programme, it has now been declared "unlimited" both in time and quantities of the drug to be supplied.
Safeguards needed for differential pricing
The Pfizer fluconazole programme has safeguards to prevent international trading, in that the drug has been made up in tablets, not capsules, so cannot be confused with the version sold in Europe and North America.
GSK has said that it now plans to follow the same pattern with the ARVs that it supplies at discount for use in Africa and other low-GDP countries, with distinctive versions of the pills and packaging.
International aid and public health agencies, including the World Health Organization, are deeply concerned that such activities can only undermine efforts to set up differential pricing so that the countries and populations with the least resources pay lower prices for essential medicines.
Problems of treatments in an unequal world
One presentation (van Leeuwen) at the recent international conference on AIDS in Barcelona, from PharmAccess International, reported on the extraordinary difficulties they had in arranging importation of antiretrovirals to four African countries for use in pilot treatment programmes. This included instances of drugs that 'went missing' at airports.
Another Barcelona presentation (Morales) reported on the emergence and decline of a market for the resale of antiretroviral drugs in Chile. The researchers observed and interviewed 90 people or agencies, including NGOs, the national AIDS programme, health centres, pharmaceutical companies and people with HIV.
One of the main causes for this informal market arose during a period when the available supply was inadequate to treat the number of people diagnosed with HIV, which meant that some individuals with pressing social needs turned to selling their medications to get food and other essentials. But who were the buyers?
Some of the buyers were people who did have legitimate prescriptions, but were unable to fill their prescriptions because of problems in the distribution chain. This market disappeared when supplies improved in quantity and became more consistently available.
On the other hand, some of the buyers were people with private health insurance who did not qualify to receive drugs through the public health system but were not prepared to tell their insurers of their HIV status. This points to the inadequacy of programmes that limit discounted supplies only to the very poorest members of a society; to ensure that the very poorest actually get treated, it is essential that those who can afford to pay something for these drugs also have access at affordable prices.
Morales C et al. Chile's Informal Market for Antiretrovirals (ARV), features, challenges and lessons for optimal regulation. XIV International AIDS Conference, Barcelona, abstract ThOrE1423, 2002.
van Leeuwen R et al. Implementation of an antiretroviral access program (CARE) in HIV-1-infected individuals in resource-poor settings: initial experiences. IV International AIDS Conference, Barcelona, abstract LbPp2209, 2002.