[e-drug] NGOs urge govt to boycott WHO meeting on definition of counterfeit drugs

e-drug
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E-DRUG: NGOs urge govt to boycott WHO meeting on definition of counterfeit drugs
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The NGOs working in the health sector have
urged the government to boycott the meeting called by International Medical
Products Anti-Counterfeiting Taskforce (IMPACT) of the WHO to discuss the issue of giving a new definition to counterfeit drugs. The NGOs alleged that this is an attempt by the big multinational companies to prevent the Indian generic drugs from going to different parts of the world.

DCGI Dr Surinder Singh and joint secretary in the Union health ministry
Debashish Panda are to attend the meeting to be held in Germany on November 24 and 25.

Questioning the legitimacy of the IMPACT in changing the definition of
counterfeit drugs, the NGOs said that counterfeit is not an IPR issue and this is basically a quality issue which should be discussed in the World Health Assembly.

The NGOs also raised this issue at a government-industry meeting convened by the Union health ministry on November 14 to discuss WHO's proposal to give a new definition to counterfeit drugs which the ministry had earlier turned down due to the resistance of the Indian drug industry. All the major industry associations like IDMA, IPA, FOPE, SPIC, CIPI, etc participated in the meeting.

The industry pleaded with the government that the new definition will act
against the Indian drug industry, especially the generic drug manufacturers as the new definition considers apparent 'trademark violations' as 'counterfeiting' cases. The Indian drug manufacturers, especially the small scale sector, are concerned over the WHO proposal as they fear the efforts would be another attempt by the big multinational companies to kill the Indian generic drug makers.

As per the proposal by the IMPACT, apparent 'trademark violations' will be
considered as 'counterfeiting' cases which the Indian drug makers said would harm exports of generic drug makers.

The current definition of WHO says counterfeit drugs are 'medicines which are deliberately and fraudulently mislabeled with respect to identity or source.
Counterfeiting occurs both with branded and generic products and counterfeit medicines include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients'.

The definition proposed by IMPACT removes the clause 'deliberately and
fraudulently' and replaces it with 'a medical product is counterfeit when there is a false representation in relation to its identity, history, or source'. It also says that 'this applies to the product, its container, packaging or other labeling information'.

IMPACT also wants to see that WHO definition on counterfeiting 'can apply to both branded and generic products and include products with correct
ingredients/components, with wrong ingredients/components, without active
ingredients, with incorrect amounts of active ingredients, or with fake packaging'.

Source:Chronicle Pharmabiz, Monday, November 17, 2008, Mumbai

Regards,

Habeeb
India
habeebibrahim_ar@yahoo.co.in

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E-DRUG: NGOs urge govt to boycott WHO meeting on definition of counterfeit drugs (3)
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Dear e-drug,

I am not clear why there is an objection to this expansion or 'new definition' of the term counterfeit. Legal pharmaceutical business will always comply to terms and conditions or the generally understood arrangements for legal generic manufacturing business. Trademark violation, I would presume, would not be entered into by any generic manufacturer that is conducting a legal pharmaceutical manufacturing activity. If we start from that understanding, the clarification that IMPACT is presenting on counterfeiting will not be seen as harming the world- wide generic manufacturing industry. I gather that many recipients of generic products would additional safeguards in this paritcular sector of pharmaceutical business, in order to continue safeguarding public health.

Regards,
Bonnie

Bonface Fundafunda PhD., MBA., B.Pharm
Manager, Drug Supply Budget Line
Ministry of Health,
P.O. Box 30205,
Ndeke House,
Lusaka,
Zambia
Tel: +260 211 25 59 11
Fax: +260 211 25 14 04
Mobile: + 260 979 25 29 00
Email: bcfunda@hotmail.com

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E-DRUG: NGOs urge govt to boycott WHO meeting on definition of counterfeit drugs (4)
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The short answer is that everyone opposes drugs that contain no active
ingredients or even dangerous contaminants, but many lives have been saved
by unlicensed generics or parallel trade in legitimate goods. These are
quite distinct issues, with vastly different risks, benefits, causes, and
effects.

The broader definition unnecessarily conflates many drugs into a single
category, and calls them "counterfeit." This attempt to expand the legal
definition of counterfeit works in tandem with industry attempts to maximize IP rights generally. We are concerned that the broader definition will negatively damage public health. Some have written on this issue at length.

Kevin Outterson
Associate Professor of Law & Director of the Health Law Program
mko@bu.edu

Boston University School of Law
765 Commonwealth Ave., Boston MA 02215
617 353 3103
http://ssrn.com/author=340746

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E-DRUG: NGOs urge govt to boycott WHO meeting on definition ofcounterfeit drugs (7)
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We need to be careful here.
ONCE a product is unlicensed it UNAUTHORIZED and there is no control. There is no certainty if there are active ingredients or even the content is unknown. We cannot claim such a product has any good to anyone.

I have a problem with expanding definitions. It is a matter of making a
definition distinct rather than expanding. You stand the risk of including
what was to be restricted or prohibited within the context of the
definition. The next step will be hosting of workshops to interpret the
definition again.

Dr W.O. WANYANGA [MPSK]
EXECUTIVE DIRECTOR
PHARMAQ LIMITED
Mobile +254 722 570 304; +254 733 748 478;
Telkom +254 202053 655; +254 770 150 917
email: wow@pharmaqltd.com

Physical Address:
I.O. Box 53362-00200, Nairobi, Kenya.
Mirage Plaza, 3rd Floor, Mombasa Road
after OiLibya & Kobil Petrol Stations, opposite Capital Centre, next to
Ramco Court

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E-DRUG: NGOs urge govt to boycott WHO meeting on definition of counterfeit drugs (11)
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The major problem has been how the countries have drafted the national legislation on counterfeits. In Uganda for instance, The Counterfeit Goods Bill, 2008 provides in its title: 'An Act to prohibit trade in counterfeit goods that infringe upon protected intellectual property rights'.

Further the definition of counterfeit under section 2 does not recognize that there are instances when third parties do not require the authority of the owner of the IPR to exploit the IPR in the goods.

These are ambiguities which if misinterpreted or abused would be detrimental to the ongoing efforts to ensure access to essential medicines for all.

Mulumba, Moses
Health and Human Rights Lawyer
mulumba_mos@yahoo.co.uk

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E-DRUG: NGOs urge govt to boycott WHO meeting on definition of counterfeit drugs (12)
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Dear Colleagues,

Rather than boycotting the meeting, I am of the opinion that it is an
opportunity not to miss. This is a forum where the best arguments for
and against the issue that I have seen in the forum can be shared.
Regardless of the many differences in opinions common sense usually
prevail at the end of the day!

Conterfeits are a global challenges such that there are several cases
where some managed to filter through the mighty and very sophisticated
US-FDA. You can imagine what is happening on this part of the world...

Bakari A. Bakari
Information Systems Manager
Medical Stores Department, Ministry of Health
P.O. Box 9081, Dar es Salaam, TANZANIA
bakari@email.unc.edu
Tel:+255 22 2860890-7
Fax: +255 22 2865814/19
Cell: +255 754 461850
URL: www.msd.or.tz