Appetite stimulants sent to starving Sudanese refugees, toxic chemicals ‘donated’ to Bosnia: many Third World countries have become dumping grounds for the pharmaceutical industry, reports Terry Slavin
THE international pharmaceutical industry is up in arms about moves to stem the flood of inappropriate drug donations to the Third World.
Hundreds of millions of dollars-worth of drugs is donated each year in the guise of philanthropy by companies seeking cheap waste disposal, enlarged markets and generous tax write-offs.
The World Health Organisation (WHO) says such “gifts” can hamper international relief operations, imperil national health strategies, and saddle Third World countries with mountains of Western toxic waste.
Some of the more ludicrous examples include appetite stimulants shipped to people in famine-stricken Sudan, and indigestion tablets sent to the hungry of Rwanda.
The WHO, which recently issued guidelines for pharmaceutical donations, says irresponsible donating causes, at best, massive administrative difficulties. Over- stretched relief workers may have risked their lives under sniper fire to rescue consignments that turned out to be useless.
In Bosnia, a team of European Union hazardous waste experts found slimming agents from Britain, toxic chemicals circa 1961 from the former East Germany, and a nasal decongestant from the former United States drugs company Merrell Dow – now Hoechst – with a 1990 expiry date covered by a 1993 sticker.
But the most irresponsible consignment consisted of 16 barrels of Dapson anti- leprosy tablets from the Norwegian company Weider: they were labelled as both Dapson and paracetamol.The tablets could have caused blood, skin, and psychiatric disorders had they been dispensed as paracetamol.
Although part of the problem is the result of small, well-meaning charities collecting cast-off drugs from pharmacies and dispensaries, the bigger culprits are the manufacturers who give huge consignments to charities for “placing” overseas. The biggest players are US companies which receive hefty tax concessions for donating drugs they would otherwise destroy.
Carolyn Green, of Echo International, a UK charity that finds pharmaceuticals for relief missions, says it costs companies about 1/kg to incinerate drugs. “If they have a ton to get rid of, they can choose to spend 50 to send it to a charity, rather than 1 000 to get it incinerated.”
According to the guidelines, agreed last May and being adopted by developing countries, a nation should accept donations only if they are on its list of needed drugs and if they arrive within a year of expiry; exceptions include if a drug were specifically requested or if it had a life of two years or less.
But Paul Grunmeir, director of Project Hope, one of the biggest US charities broking pharmaceutical donations, criticises the guidelines. He says that with the exception of Merck & Co, and Johnson & Johnson, which produce drugs specifically for donations, companies will give a drug only if it cannot be sold – and the cut-off date for shipment to a wholesaler ranges from six to 12 months. He argues that by insisting that donations arrive a year before expiry, “the whole area of philanthropy would disappear”.
US drugs manufacturers have also complained about the guidelines. They have told the WHO that their donation programmes would be curtailed by up to 95% if all countries slavishly adopted the guidelines.
The US giant Eli Lilly has said that it would be able to send only 5% of its current donations. Eli Lilly is responsible for a high-profile donation that went awry. At the height of the Rwandan refugee crisis in 1994, the company announced the “largest one-time pharmaceutical donation ever”, and sent millions of Ceclor CD tablets – an antibiotic still awaiting licensing in the US – through several US charities.
But Ceclor CD was not on the WHO’s list of essential refugee drugs; Mdecins Sans Frontires, the leading agency, refused to prescribe it.
Explaining the industry’s concern about restrictions, Jean Francois Gaulis, director of public affairs at the Geneva-based IFPMA, says: “The non-governmental organisations want to close and control the system. We, as manufacturers, think we can analyse the need in certain situations.”
But the WHO has seen little evidence of this. In Armenia, 50% of drugs donations between 1990 and 1995 arrived past their expiry date. In Moldova, doctors were blindly prescribing drugs without adequate information about them.
As for the decongestants sent to Bosnia, Hoechst was, despite being given a lot number, unable to explain why an expiry date of October 1990 was covered by a sticker saying 1993.
Zoe Fairtlough, Merck representative, said 40% of its donations could be affected by the guidelines, including its much applauded donations of Mectizan, used to treat river blindness.
US manufacturers argue that the guidelines should be approved by the WHO’s governing body, the World Health Assembly, next year. But many countries already have policies based on the guidelines, with ministries of health insisting they approve all donations. Alarmed donors say red tape can delay consignments for months.
Dr Hans Hogerzeil, the co-ordinator of the WHO’s action programme on essential drugs, says he can understand the donors’ problem. “But imagine if China wanted to flood the US with its pharmaceuticals by sending them directly to hospitals. The Food and Drug Administration simply wouldn’t allow it. So why should US pharmaceutical companies think they can flout national authorities?”
Even where donations meet an important need for the recipient, the company is at the same time creating markets for its products, he points out. An Aids treatment given to Africa by Janssen, for example, was a good donation but it also led to a fourfold increase in the firm’s market share.
The WHO’s Hogerzeil says he is not concerned about industry threats of severely curtailed donations: “If a drug isn’t good enough to be sold within 12 months in the US, it isn’t good enough to be donated. It proves to me that what we are doing is right.”