Europe steps in to protect discounted drugs for developing countries

Graham McKerrow, HIV i-Base

The European Union has drawn up regulations about the shipping of drugs to protect discounted treatments intended for people in developing countries. The move follows reports that millions of dollars worth of discounted GlaxoSmithKline (GSK) drugs were diverted from Africa for resale at European prices.

At the same time law enforcement agencies from several European countries met at the Europol offices in The Hague to coordinate their investigations into a “wide web of trafficking” schemes that are making millions of dollars reimporting the medicines.

Some treatment activists say the plans don’t go far enough.

The EU’s proposed rules have been approved by the European Commission but now have to be adopted by each country separately — which they are expected to do by the end of the year. The regulations would allow pharmaceutical companies to register, label and place special logos on shipments of discounted drugs so that different packaging would distinguish them from the higher-priced medicines intended for richer nations.

The Commission has also called for more border controls and tighter customs checks. The pharmaceutical companies have been lobbying for the new rules since the theft of the GSK drugs was revealed. The EU proposals apply to drugs to treat HIV, TB and malaria but they could be extended to cover treatments for other conditions.

EU trade commissioner Pascal Lamy was quoted by Associated Press as saying he hoped other countries such as the United States, Canada and Japan would adopt similar measures.

In a separate move, investigators from Belgium, France, Germany and the Netherlands are coordinating their inquiries into the thefts, in which 28 shipments of Combivir (AZT and 3TC), Epivir (3TC) and Trizivir (AZT, 3TC and abacavir) were diverted over a 12-month period. The drugs were sold to Senegal, Ivory Coast, the Republic of Congo, Togo and Guinea-Bissau for about $3 million. They would sell in Europe for about $18 million.

The drugs were diverted by European wholesalers to Holland, Germany, Switzerland and the UK before being detected by Customs authorities in Antwerp in July.

Investigators believe there were a number of businesses and individuals involved in the scam, moving transactions through several companies to avoid detection. So far only two people have been arrested.

The New York Times reports that AIDS organisations in Africa were connected with the fraud and the head of one has been sacked. One unnamed law enforcement officer was quoted as saying the volume of diverted drugs “suggests some kind of concerted effort in Europe and Africa”.

The NYT reports that there is “evidence that some of the humanitarian organisations that distribute the drugs in Africa at least knew that the products were being resold”.

One example is that drugs intended for the Senegalese organisation Africa Helps Africa were reimported to Europe. As a result the country’s president, Abdoulaye Wade, sacked the organisation’s chief executive Abdou Latif Guèye for “extremely serious errors” in connection with the case. Guèye told a press conference there was “simply a surplus” of the drugs so he tried to exchange them for “other much-needed drugs and equipment”.

A German businessman, one of those arrested in connection with the fraud, said he was contacted by an NGO in the Republic of Congo that wanted to sell some of its GSK drugs to raise money to buy other AIDS drugs.

NGOs not involved in the fraud are concerned that the allegations could damage the reputation of all NGOs. Rachel Cohen of Médecins Sans Frontières is quoted in the NYT as saying: “It’s horrifying if NGOs or anybody else is involved in this. The people who are ultimately going to pay for this are those without adequate access to drugs.”

In Europe, GSK has provided the Dutch authorities with the package codes of the diverted shipments, and Dutch Health Inspection (DHI) has recalled several resold consignments.

According to a report in The Lancet, DHI says the Dutch company Asklepios distributed 6,000 packages of Combivir and Epivir to wholesalers in the Netherlands, and 30,000 packages of Combivir, Epivir and Trizivir in Germany. The wholesalers sold the drugs on to pharmacies. Asklepios denies any wrongdoing.

The Lancet also quotes Geert Haverkamp of the Dutch treatment access group Pharmaccess calling for further steps to secure discounted drug shipments. Pharmaceutical companies should establish a centralised distribution system, maybe in conjunction with the World Health Organisation, with three to five warehouses in Africa where all companies could deliver their drugs and where all treatment programmes could order them.

“This would make logistics and control easier,” Haverkamp told The Lancet, adding: “It’s a necessary step if we want to start large-scale programmes for helping millions of people in Africa.”

See also ‘Profiteers undermine preferential pricing and make millions diverting cheap drugs sent to Africa’, HTB 3,9, November 2002.

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