E-DRUG: Anti-Fakes Bill Threatens Access to Generics / All Africa
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The East African / 08.09.08
by Dagi Kimani
[Copied as fair use]
Nairobi, Sep 08, 2008 (The East African/All Africa Global Media via
COMTEX) -- 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.