Nigeria Calls For Convention Against Counterfeit Medicines

Lyon, France—Calling counterfeit medicines a “form of terrorism against public health,” a senior Nigerian health official urged a 14-15 November international conference in Lyon, France to support the adoption of an international convention to fight the problem.

“I urge this conference [to adopt an] an international convention on counterfeiting of pharmaceuticals,” said Dora Akunyili, director general of the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria. Akunyili said there is no international definition on what constitutes counterfeit medicines, with the World Health Organisation having one definition and the United States Food and Drug Administration another.

Jacques Kuete of the Cameroon customs agency and Ze Mboutou Thomas, head of the surveillance division of the Cameroon finance ministry, said in an interview that there was a need for international regulation on counterfeit medicines.

There are various organisations involved in the issue of counterfeit medicines. The World Customs Organisation (WCO) is carrying out two pilot projects on medicines in Senegal and Azerbaijan, Michel Danet, secretary general of the WCO, told the conference.

Mboutou Thomas said the WCO, however, was not the right place for international counterfeit medicine regulation but rather the World Health Organisation (WHO), a position he said was shared during the conference by Danet.

Kuete argued that fake medicines constitute a “very specific problem,” different from other types of counterfeiting.

The WHO and the Council of Europe, based in Strasbourg, France, are planning on pursuing treaties or conventions especially on counterfeit medicines, according to a Swiss conference participant. Officials at the WHO and the council could not be reached by press time.

Akunyili made an impassioned speech at the recent Second Global Congress on Combating Counterfeiting and Piracy, sharing some stories of what it takes to fight this problem in Africa. After being appointed by Nigerian President Olusegun Obasanjo to work on counterfeiting, which she said he had personally been fighting despite political opposition, there was an assassination attempt against her and NAFDAC buildings were set on fire.

But she said she would continue to fight for NAFDAC’s “vision, mission and goal” strategy on counterfeits.

A Special Nigerian Problem

Akunyili said that counterfeit medicines are “most prevalent in developing countries” but it is a particular problem in Nigeria. Drugs produced in Nigeria are often not accepted by other African countries because of the prevalence of counterfeits, she said.

Mboutou Thomas said that fake medicines from Nigeria is a “very, very big problem,” as Nigeria is a country of production but also a transit country for fake medicines to Asia and India.

A survey of Nigeria indicated that “80 percent of the drugs distributed in major pharmacies in the capital city of Lagos were counterfeit,” according to Interpol conference data. The WHO estimates that counterfeit drugs account for 10 percent of all pharmaceuticals globally, rising to 25 percent in developing countries, according to Interpol.

In general, a lot of the counterfeit drugs circulating in Africa stem from India, Akunyili said. Moreover, 12 percent of all drugs in Russia are believed to be counterfeits, she said. The situation often gets worse in cases of emergency (such as the tsunami in Asia), according to Eric McIntosh, chief investigator of the surveillance unit of the Australian Therapeutic Goods Administration.

Examples of counterfeit medicines, such as malaria or vitamin pills, are capsules merely containing olive oil as the active substance in the original medicine has neither a smell nor taste; the medicine contains a different active substance than what is indicated on the package; drugs without an expiry date or drugs of which the full name and address of the manufacturer are not given. These products are different from generic medicines, which are copies of a brand name product.

Often the counterfeit medicines are very difficult to distinguish from the original medicines as the packages look fine, Akunyili said, “because this is where they [the counterfeiters] invest.” And she was clear in her message: “There are no good counterfeit drugs.”

These drugs can lead to drug resistance, particularly for antibiotics, organ damages or even death, Akunyili said, noting that there is hardly any family in Nigeria that does not know of any incidence related to counterfeit medicines. She said a friend of hers had died of counterfeit anti-diabetes drugs.

NAFDAC is informing people about the dangers of counterfeit drugs through billboards and in schools, and Nigerian banks had agreed not to lend money to projects unless it could be proven that the medicines had been approved by NAFDAC. Landlords of apartments where counterfeits drugs were found to be stored were also arrested, Akunyili said.

As for resources, Akunyili advised others at the conference to “start showing that you can do a lot with little,” and as others see that you were serious, funding will follow. NAFDAC also has generated some income through fines.

The View From The United States

Chris Israel, co-ordinator for international intellectual property enforcement at the US Department of Commerce, told Intellectual Property Watch that one could not help seeing the issue of counterfeit medicines as having more of a human impact than other counterfeit issues. “It hurts individuals [and] it hurts society when that happens,” Israel said.

However, he noted that this issue was “part of a larger environment” and the issue was linked with other counterfeit issues. Thus they all had to be fought with “equal energy,” he said. Critics have charged that industry and government have at times held up incidents in the pharmaceutical and airplane parts industries to win public sympathy for an overall anti-counterfeit agenda.

The issue of whether lower prices in general would reduce the amount of counterfeits was not discussed at the conference but when asked about the issue, Israel replied that “those are market decisions.” He said that his unit’s focus was to create an environment to confront stolen intellectual property, while the companies’ role was to produce the best products possible. “Our primary focus should be on enforcement,” Israel said.

Doug Clark of the Lovells law firm in Shanghai said that no matter how low the prices are cut, the producers of counterfeit goods can always sell them cheaper.

The conference in Lyon was organised by the WCO, Interpol, World Intellectual Property Organisation, Global Business Leaders Alliance Against Counterfeiting, the International Trademarks Association and the International Chamber of Commerce.