WHO meeting on definition of counterfeit drugs

[Guest guest]

MSF warns Indian govt of developed countries' attempt to trap generics under counterfeit drugs

Friday, November 21, 2008 08:00 IST Ramesh Shankar, MumbaiThe far cry against the WHO's attempt to give a new definition to counterfeit drugs is mounting day by day. Close on the heels of the Indian industry expressing concern over the WHO proposal, an international humanitarian medical aid organization Medecins Sans Frontieres (MSF) has urged the Indian government to keep away from the developed countries' deliberate attempt to confuse the two totally different issues of substandard drugs and counterfeit drugs which is designed to trap the legally manufactured generic drugs from developing countries under the definition of counterfeiting. "By confusing the issues of counterfeit medicines and

substandard medicines, WHO and governments are attacking the wrong problem, which does nothing to improve the quality of medicines, which is a far greater public health concern. Counterfeit is a trademark and IPR issue that should not be confused with quality issues," MSF's project manager for India Leena Menghaney said. In a letter to Union health minister Dr Anbumani Ramadoss, the MSF urged the Indian government to project a true picture in this regard at the forthcoming international meeting called by IMPACT of the WHO on giving new definition to counterfeit drugs. India's role at these negotiations will strengthen negotiations by developing countries to prevent such trade barriers from being created. DCGI Dr Surinder Singh and joint secretary in the Union health ministry Debashish Panda are scheduled to attend the meeting to be held in Germany on November 24 and 25.The MSF is seriously concerned that legally manufactured

generics could fall under the definition of counterfeiting being proposed under international resolutions, agreements or treaties. Indeed the 'Anti Counterfeiting Trade Agreement (ACTA)' negotiations are being conducted with little participation from developing countries. In addition, the anti-counterfeit issue also needs to be seen in the context of moves by the European Union and other developed countries to strengthen intellectual property enforcement. One such mode of enforcement is to amend regulations that govern practices by customs authorities towards counterfeit goods across the globe. In conjunction, this could lead to customs authorities, seizing or delaying the transit of legitimate generic medicines, on suspicion of being 'counterfeit'. As a consequence, there is a risk that life-saving essential medicines imported from India may be banned or held up, such as those used by Médecins Sans Frontières in African countries to

treat people living with HIV/AIDS. The consequences on access to life-saving medicines and on the sustainability of AIDS and other treatment programmes that rely on generic production or importation would be devastating, MSF warned the Indian government. MSF currently treats 1.4 lakh people living with HIV/AIDS in 27 countries including India. Most of the patients in MSF's treatment programmes are receiving affordable generic medicines manufactured in India that allow the MSF to treat the largest possible number of people. Access to affordable medicines is therefore key in making life-extending treatment available to more people who need it. (Pharmabiz dt Nov. 21, 2008)

Dr. Geer M. Ishaq

Assistant Professor

Dept. of Pharmaceutical Sciences

University of Kashmir

Srinagar-190006 (J & K)

Ph: 9419970971, 9906673100

Website: http://ishaqgeer.googlepages.com

From Chandigarh to Chennai - find friends all over India. Click here.

[Guest guest]

Hi,

I personally know the young,hard hitting, firebrand, activist,

advocate, MSF's project manager for India Leena Menghaney from New

Delhi, who has been quoted in Geer's post. She usually takes

informed stand on the issues.

However in this case I am yet to be convinced. Hence I desire more

information on the issue.

Please see my post from E-drug, cross posted below.

-----------------------------------------------

E-DRUG: NGOs urge govt to boycott WHO meeting on definition of

counterfeit drugs (2)

------------------------------------------------

Hi,

I am interested in knowing more about this before taking an informed

decision on the issue. Will someone enlighten further?

Dr Vijay Thawani,India.

------------------------------------------------

In netrum , " Geer M. Ishaq " <ishaqgeer@...> wrote:

>

> MSF warns Indian govt of developed countries' attempt to trap

generics under counterfeit drugs

>

> Friday, November 21, 2008 08:00 IST

> Ramesh Shankar, Mumbai

>

> The far cry against the WHO's attempt to give a new definition to

counterfeit drugs is mounting day by day. Close on the heels of the

Indian industry expressing concern over the WHO proposal, an

international humanitarian medical aid organization Medecins Sans

Frontieres (MSF) has urged the Indian government to keep away from

the developed countries' deliberate attempt to confuse the two

totally different issues of substandard drugs and counterfeit drugs

which is designed to trap the legally manufactured generic drugs

from developing countries under the definition of counterfeiting.

>

> " By confusing the issues of counterfeit medicines and substandard

medicines, WHO and governments are attacking the wrong problem,

which does nothing to improve the quality of medicines, which is a

far greater public health concern. Counterfeit is a trademark and

IPR issue that should not be confused with quality issues, " MSF's

project manager for India Leena Menghaney said.

>

> In a letter to Union health minister Dr Anbumani Ramadoss, the MSF

urged the Indian government to project a true picture in this regard

at the forthcoming international meeting called by IMPACT of the WHO

on giving new definition to counterfeit drugs. India's role at these

negotiations will strengthen negotiations by developing countries to

prevent such trade barriers from being created.

>

> DCGI Dr Surinder Singh and joint secretary in the Union health

ministry Debashish Panda are scheduled to attend the meeting to be

held in Germany on November 24 and 25.

>

> The MSF is seriously concerned that legally manufactured generics

could fall under the definition of counterfeiting being proposed

under international resolutions, agreements or treaties. Indeed

the 'Anti Counterfeiting Trade Agreement (ACTA)' negotiations are

being conducted with little participation from developing countries.

>

> In addition, the anti-counterfeit issue also needs to be seen in

the context of moves by the European Union and other developed

countries to strengthen intellectual property enforcement. One such

mode of enforcement is to amend regulations that govern practices by

customs authorities towards counterfeit goods across the globe. In

conjunction, this could lead to customs authorities, seizing or

delaying the transit of legitimate generic medicines, on suspicion

of being 'counterfeit'.

>

> As a consequence, there is a risk that life-saving essential

medicines imported from India may be banned or held up, such as

those used by Médecins Sans Frontières in African countries to

treat people living with HIV/AIDS. The consequences on access to

life-saving medicines and on the sustainability of AIDS and other

treatment programmes that rely on generic production or importation

would be devastating, MSF warned the Indian government.

>

> MSF currently treats 1.4 lakh people living with HIV/AIDS in 27

countries including India. Most of the patients in MSF's treatment

programmes are receiving affordable generic medicines manufactured

in India that allow the MSF to treat the largest possible number of

people. Access to affordable medicines is therefore key in making

life-extending treatment available to more people who need it.

(Pharmabiz dt Nov. 21, 2008)

> Dr. Geer M. Ishaq

> Assistant Professor

> Dept. of Pharmaceutical Sciences

> University of Kashmir

> Srinagar-190006 (J & K)

> Ph: 9419970971, 9906673100

> Website: http://ishaqgeer.googlepages.com

>

>

> Connect with friends all over the world. Get India

Messenger at http://in.messenger./?wm=n/

>

[Guest guest]

Dear Members:

Here is some more information related to the topic copied from www.rediff.com

With regards

Dr. Geer M. Ishaq

Assistant Professor

Dept. of Pharmaceutical Sciences

University of Kashmir

Srinagar-190006 (J & K)

Ph: 9419970971, 9906673100

Website: http://ishaqgeer.googlepages.com

Counterfeit definition worrys pharmas

Joe C Mathew in New Delhi

The domestic drug industry is concerned over ongoing World Health Organisation negotiations that aim to bring non-health issues, having no direct implications on the safety of a drug, within the ambit of the definition of "counterfeit medicine".

The industry feels that a proposal by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the WHO to consider apparent 'trademark violations' as 'counterfeiting' cases would harm exports of generic drug makers.

If the changes do go through, they say, foreign drug firms could stall exports of low-cost versions of patent expired medicines to key markets. Today, Indian firms have several brands that sound similar to those of multinational brands, industry sources explained. For example, global drug major Pfizer has an erectile dysfunction medicine Viagra, while Indian companies make generic versions of Viagra with similar sounding names.

Currently, this would at the most be treated as a trademark violation. However, according to the definition proposed by IMPACT, the Indian product could be rejected as counterfeit, the sources explained. This attempt to widen the definition of counterfeit medicine is happening at a time when a deliberate attempt is being made to label India as a major source of counterfeit medicines. Indian companies, increasingly dependant on exports of cheap off-patented medicines to developed markets to drive business growth, will find this a major problem, the sources said. Sensing the potential harm, the Indian Pharmaceutical Alliance of top domestic pharma firms has appealed to the international generic industry, civil society and academia to oppose the creation of another non-tariff barrier in the name of counterfeit drugs. "The IMPACT definition refers to 'history', which is mischievous. This could lead to generics being treated as counterfeits," said D G

Shah, secretary general, IPA. He also pointed out that the proposed definition, if read with EC Regulation Article 2.1 © of the European Union, could amount to a serious threat to India's pharma exports. The EC Regulation allows seizure of counterfeit products even in transit.

Health ministry officials say that the IMPACT proposal is being studied and that this would likely figure on the agenda of the next World Health Assembly. 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".

IMPACT has representatives from 22 organisations including INTERPOL, Organisation for Economic Co-operation and Development, World Intellectual Property Organisation and World Trade Organisation.

From: Vijay <drvijaythawani@...>netrum Sent: Friday, 21 November, 2008 9:59:52 PMSubject: Re: WHO meeting on definition of counterfeit drugs

Hi,I personally know the young,hard hitting, firebrand, activist, advocate, MSF's project manager for India Leena Menghaney from New Delhi, who has been quoted in Geer's post. She usually takes informed stand on the issues. However in this case I am yet to be convinced. Hence I desire more information on the issue.Please see my post from E-drug, cross posted below.------------ --------- --------- --------- -------- E-DRUG: NGOs urge govt to boycott WHO meeting on definition of counterfeit drugs (2)------------ --------- --------- --------- ---------Hi,I am interested in knowing more about this before taking an informed decision on the issue. Will someone enlighten further? Dr Vijay Thawani,India.------------ --------- --------- --------- ---------In netrumgroups (DOT) com, "Geer M. Ishaq" <ishaqgeer@. ..> wrote:>> MSF warns Indian govt of developed countries' attempt to trap generics under counterfeit drugs> > Friday, November 21, 2008 08:00 IST > Ramesh Shankar, Mumbai> > The far cry against the WHO's attempt to give a new definition to counterfeit drugs is mounting day by day. Close on the heels of the Indian industry expressing concern over the WHO proposal, an international humanitarian medical aid organization Medecins Sans Frontieres (MSF) has urged the Indian government to keep away from the developed countries' deliberate attempt to confuse the two totally different issues of substandard drugs and counterfeit drugs which is designed to trap the legally manufactured generic drugs from developing countries under the definition of counterfeiting. >

> "By confusing the issues of counterfeit medicines and substandard medicines, WHO and governments are attacking the wrong problem, which does nothing to improve the quality of medicines, which is a far greater public health concern. Counterfeit is a trademark and IPR issue that should not be confused with quality issues," MSF's project manager for India Leena Menghaney said. > > In a letter to Union health minister Dr Anbumani Ramadoss, the MSF urged the Indian government to project a true picture in this regard at the forthcoming international meeting called by IMPACT of the WHO on giving new definition to counterfeit drugs. India's role at these negotiations will strengthen negotiations by developing countries to prevent such trade barriers from being created. > > DCGI Dr Surinder Singh and joint secretary in the Union health ministry Debashish Panda are scheduled to

attend the meeting to be held in Germany on November 24 and 25.> > The MSF is seriously concerned that legally manufactured generics could fall under the definition of counterfeiting being proposed under international resolutions, agreements or treaties. Indeed the 'Anti Counterfeiting Trade Agreement (ACTA)' negotiations are being conducted with little participation from developing countries. > > In addition, the anti-counterfeit issue also needs to be seen in the context of moves by the European Union and other developed countries to strengthen intellectual property enforcement. One such mode of enforcement is to amend regulations that govern practices by customs authorities towards counterfeit goods across the globe. In conjunction, this could lead to customs authorities, seizing or delaying the transit of legitimate generic medicines, on suspicion of being 'counterfeit' .

> > As a consequence, there is a risk that life-saving essential medicines imported from India may be banned or held up, such as those used by Médecins Sans Frontières in African countries to treat people living with HIV/AIDS. The consequences on access to life-saving medicines and on the sustainability of AIDS and other treatment programmes that rely on generic production or importation would be devastating, MSF warned the Indian government. > > MSF currently treats 1.4 lakh people living with HIV/AIDS in 27 countries including India. Most of the patients in MSF's treatment programmes are receiving affordable generic medicines manufactured in India that allow the MSF to treat the largest possible number of people. Access to affordable medicines is therefore key in making life-extending treatment available to more people who need it. (Pharmabiz dt Nov. 21, 2008)>

Dr. Geer M. Ishaq> Assistant Professor> Dept. of Pharmaceutical Sciences> University of Kashmir> Srinagar-190006 (J & K)> Ph: 9419970971, 9906673100> Website: http://ishaqgeer. googlepages. com> > > Connect with friends all over the world. Get India Messenger at http://in.messenger ./ ?wm=n/>

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[Guest guest]

Dear Habeeb,

Is this mail addressed to me?

I did not get it.

Please explain.

Vijay

>

> Dear Sir,

>

> I have not yet received your mail as I have opted for 'digest'

mode in E-drug. We have to wait till 25th Nov to get a clear picture

of this.

>

> Regards,

> Habeeb

>

>

>

>

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