Anti-fakes bill threatens access to generics

Saturday September 6 2008

A key weakness of the draft law is that it does

A key weakness of the draft law is that it does not distinguish intellectual property rights mechanical details such as trademarks, copyright, patents and data protection from quality control issues related to medicines, which basically revolve around formulation. Photo/ANTHONY KAMAU. 

By DAGI KIMANI

Kenyan health activists last week slammed the country’s proposed anti-counterfeiting law, saying that provisions had been slipped into it to prevent the importation of cheap generic medicines.

According to the activists, the Kenya Anti-Counterfeit Bill 2008 does not distinguish between medicines, which they say are essential, life-saving products, and such items as pens, DVDs and batteries, and also contravenes the provisions of the 2001 Industrial Property Act (IPA), which paved the way for the widespread use of generic ARVs to manage HIV/Aids.

“The Bill contains various ambiguities, which if misinterpreted or abused would be detrimental to the government’s ongoing efforts to ensure access to essential medicines for all Kenyans,” James Kamau of the Kenya Access Treatment Movement (Ketam) told The EastAfrican last week.

“The ambiguities of the proposed legislation should be addressed in order to ensure that interested parties, including the multinational pharmaceutical industry, do not misuse the Bill as a front to discriminate against more affordable generic competition.”

Ketam and Health Action International (HAI) are championing a redrafting of the proposed legislation to remove the contentious provisions.

The anti-counterfeit Bill was first published last year, but lapsed when parliament was dissolved to pave way for general elections. The Bill was republished this year on July 1 as the Anti-Counterfeit Bill, 2008.

The law is supposed to protect Kenyans against counterfeits, which are defined as imitations that are made with the intent to deceptively represent content or origins. Analysts say that counterfeits, mainly from Asian countries and China, cost the Kenyan economy millions of dollars each year.

According to Ketam and HAI, while the draft Bill has some important strategies to combat the availability of counterfeit goods in Kenya, some of its provisions, if misinterpreted or abused, would be detrimental to the government’s ongoing effort to ensure access to medicines for poor citizens.

A key weakness of the draft law, the two say, is that it does not distinguish intellectual property rights (IPRs) mechanical details such as trademarks, copyright, patents and data protection from quality control issues related to medicines, which basically revolve around formulation.

Elsewhere, the two organisations add, some of the provisions in the draft Bill go beyond the commitments required of Kenya under the World Trade Organisation agreement on trade-related aspects of IPRs (the WTO TRIPS Agreement). Such “TRIPS-plus” measures, the organisations say, are known to hinder access to essential medicines.

“The way the Bill defines what ‘counterfeiting’ is could easily be taken to cover generic medicines,” said Mr Kamau. “This is dangerous, since generics form the backbone of our Aids treatment programmes, and are also widely used in the treatment of such diseases as malaria and tuberculosis.”

According to the Bill, counterfeiting is “the manufacture, production, packaging, re-packaging, labeling or making, whether in Kenya or elsewhere, of any goods whereby those protected goods are imitated in such manner and to such a degree that those other goods are identical or substantially similar copies of the protected goods.”

But generics, which are usually copies of branded medicines containing exactly the same active ingredients, are usually not considered counterfeits unless there is a dispute with the patent-holder.

When correctly formulated, generic medicines provide the same quality safety and efficacy as the original branded products and are marketed in compliance with international and national patent law. They are also identified by their internationally approved non-proprietory scientific name.

In contrast, the World Health Organisation defines a counterfeit medicine as “a medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source.

Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.”

Typically, generic medicines are between 20 to 90 per cent less expensive than their equivalent branded originals, which is a major access advantage in resource-poor settings such as Kenya.

According to Mr Kamau, it is also significant that the Kenya anti-counterfeit Bill has been published at a time when the Organisation for Economic Co-operation and Development countries are pushing for the enactment of a global Anti-Counterfeiting Agreement (ACTA).

ACTA negotiations, Mr Kamau says, are being conducted covertly with little participation from developing countries in a process that could undermine the Trips provisions that allowed more access to generics.