Why WHO needs to change counterfeit definition?

[Guest guest]

Hi Anupama,Thanks for the links. The article "Counterfeit Drugs" by Dr K Balasubramaniam was informative. I quote some statements from his write up.

The editing and highlighting has been done by me.

1. A counterfeit drug is a legal and criminal issue which should not be mixed with quality and patient safety.

2. There is at present international debates regarding the negative impact of intellectual property rights (IPRs) on access to knowledge, public interest and development. 3. If in this scenario where access to drugs is threatened by patent protection, any attempt to enforce IP infringement will further deny people living in the developing countries access to drugs.

4. Why are the US, EU and the multinational drug companies (MNCs) negotiating an Anti-Counterfeit Trade Agreement (ACTA) behind closed doors? This is a classic example of strategic forum shifting from one forum to another in order to enforce strong patent protection. 5. The present focus on counterfeit drugs and the Anti-counterfeit Trade Agreement (ACTA) is the latest in the strategic forum shifting by the US, EU and the multinational drug industry to ensure strict enforcement of intellectual property rights (IPRs).

6. WHO has developed the following definition of counterfeits. "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 correct ingredients or with the wrong ingredients without ingredients, with insufficient active ingredients, or with fake packaging".

7. In the WHO definition, counterfeits clearly apply only to "mislabelling" of medicines and only to those situations in which the mislabelling is carried "deliberately" and "fraudulently". Thus it excludes those situations in which there are legitimate disputes about the trade mark status of a label and the burden of proof is with the accuser. On the other hand IMPACT (International Medical Products Anti-counterfeiting Task Force) a WHO initiative, gives "new definition" of counterfeit medical product. A medical product is counterfeit when there is a false representation in relation to identity, history or source. This applies to the product, its container or other packaging or labelling in formations. Counterfeits can apply to both branded and generic products. Counterfeit may include products with correct ingredients/components, with wrong ingredients components, without active ingredients with incorrect amount of active ingredients or with fake packaging", by avoiding the terms, "deliberately and fraudulently" relieving the investigators of the onus of proving voluntary possession of counterfeit medical products and transferring the burden of proving their good intentions on those found in possession of counterfeits. This is a traversity of the normal forms of justice where the guilty person has to prove he is innocent and not guilty.

8. Member States should ask the WHO why IMPACT, changed its original definition. The new definition is designed to assist MNCs to get their IPRs strongly protected. On the other hand the developing countries will face more problems to get access to life saving drugs.

9. WHO appears to initiate IP enforcement through its initiative IMPACT which is supported by the International Federation of Pharmaceutical Association (IFPMA), representatives of WTO, WIPO, OECD and Interpol.

10. IMPACT tends to be industry oriented and to blurs the distinction between counterfeits on the one hand and generics, parallel trade and compulsory licensing which are legitimate business practices, on the other. 11. The strategy behind the whole issue seems to be to casually mix every thing together including piracy, compulsory licensing, parallel imports and generics under the single banner of the emotive term "counterfeit" use it to frighten consumers, harness the power of public health safety concerns, link it with IP protection and enlist public sector support in enforcing private rights meaning that taxpayers dollars would be used to protect private rights

12. The presentation Dr V Reggie of WHO Geneva gave to WHO/SEARO, New Delhi on 7th August. The presentation was entitled "Counterfeits Kill!" The graphic shows a venomous hooded cobra ready to strike! This will certainly frighten consumers. However, it is not factually correct. The two definition of "Counterfeit" given in the presentation includes medicines with the correct ingredients. These counterfeits will certainly not kill. Therefore a sweeping title is misleading; another statement refers to "the 'perfect copy' myth without defining what a perfect copy is. This is blatant thinly veiled attempt to equate generics with "perfect copy" and thereby call quality and safety of generics into question. Another department in the WHO actively promoted the use of generics. When experts within WHO disagree where do the general public go?

13. The presentation quite correctly, states that not all substandard drugs are counterfeit. Therefore a system to monitor infringement of IPRs and to strictly enforce patent protection to keep counterfeits out of the market can never weed out all substandard drugs from this market. It is also accepted that strict enforcement of IPRs will reduce access to life saving drugs.

14. To remove counterfeits, the best solution is to remove the cause. In developing countries, counterfeits enter the market because of the lack of required drugs. The solution to counterfeit is, therefore, for the government to ensure the availability of the required supply of needed drugs at affordable price by implementing the new WHO Global Strategy and Plan of Action on Public Health Innovation and Intellectual Property approved at the WHA in May 2008. This should be the priority for the WHO not to redefine counterfeit and call counterfeit a killer.

Well, well the issue seems to be getting clearer now.Let us have the debate on this till Ram picks up the moderation of his topic.

Dr Vijay Thawani

[Guest guest]

Hi,

I agree with Geer that " WHO needs to be specific and unambiguous

while defining its contours lest it may be misused as a tool to

create barriers for the generic industry " .

Changing definition for betterment of humanity is welcome but

definitely not for obstructing the generic flow of medicines which

improves the access to affordable medicines. WHO aspires to

get " Health for all " , so its actions should be louder than words.

It is indeed painful that the powerful pharmaceutical industry

leaves nothing to suffocate humanity with its dirty designs. And

those who are party to such games are doing dis-service to humanity.

History is replete with examples that when the atrocities of tyrants

becomes unbearable,it ushers revolution. The pharmaceutical giants

need to understand the public suffering and resist from further arm

twisting of marginalised populations. Exploitation of the sick in

the name of medicines must stop.

Vijay Thawani

>

> Dear Sir: A FEW IMPORTANT CONCERNS EXPRESSED BY INDIAN DRUG MAKERS

ARE:

>

> Though it is true that developing countries need to do a lot to

improve their drug manufacturing practices, as well as other aspects

of regulation such as clinical trials and post-marketing

surveillance of drugs. The Western governments have a legitimate

right to put pressure on the developing-country governments to take

earnest steps to enhance regulatory standards. They would, however

may do this in a straightforward manner, rather than acting tricky.

>  

> WHO IMPACT defines a medical product as counterfeit when there is

a false representation in relation to its identity, history or

source. This Impact definition of counterfeiting not only

clubs " substandard " with " counterfeit " , but also adds a new

dimension to the definition by inserting the word " history " without

being specific. This definition, as many quarters apprehend, could

be interpreted in a manner that would create barrier to generics.

Instead of being ambiguous in relation to the term, " history " in the

new definition, WHO need to be specific and unambiguous while

defining its contours lest it may be misused as a tool to create

barriers for the generic industry. Though the fact that counterfeit

should relate to the violation of trademark remains largely

unobjectionable, attemps (particularly of EU) to relate it to

patent infringement too have been opposed by many.

>  

> Indian Pharmaceutical Alliance has viewed that the use

of " intellectual property " instead of " trademark " or " copyright " is

a matter of concern as it suggests enlarging the scope of anti-

counterfeiting activity. The Indian drug industry fears a two

pronged strategy by the Western authorities, acting at the behest of

the large global pharma corporations to curb the growth of generic

industries from countries like India. One prong is in respect of

quality regulation, and the other, concerns IPR. This contrasts

with the Western government's anxiety to promote generic drugs to

contain surging government expenditure on health. The multilateral

framework (under TRIPS and the Doha declaration on public health)

has already given a lot of leeway for the generic drug industry to

thrive.

>  

> Trade flexibilities obtained by developing countries like

compulsory licensing provision, parallel importation of original

goods from a third country where they have been sold by the

appropriate right-holder, mechanism that allows strong-generic-

industry countries to export to countries without sufficient

manufacturing capacities in certain defined situations, the freedom

for national governments to define " patentable subject matter "

taking into account domestic concerns even while being TRIPS-

compliant have been obtained by the developing world after hard

bargaining in the multilateral forums. The fear now is that the two-

pronged strategy of the West is to subvert these flexibilities.

>

>

> 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: Vijay <drvijaythawani@...>

> netrum

> Sent: Saturday, 22 November, 2008 7:35:19 AM

> Subject: Why WHO needs to change counterfeit definition?

>

>

> Hi Anupama,

> Thanks for the links. The article " Counterfeit Drugs " by Dr K

Balasubramaniam was informative. I quote some statements from his

write up.

> The editing and  highlighting has been done by me.

> 1. A counterfeit drug is a legal and criminal issue which should

not be mixed with quality and patient safety.  

> 2. There is at present international debates regarding the

negative impact of intellectual property rights (IPRs) on access to

knowledge, public interest and development. 

>  

> 3. If in this scenario where access to drugs is threatened by

patent protection, any attempt to enforce IP infringement will

further deny people living in the developing countries access to

drugs.

> 4. Why are the US, EU and the multinational drug companies (MNCs)

negotiating an Anti-Counterfeit Trade Agreement (ACTA) behind closed

doors?  This is a classic example of strategic forum shifting from

one forum to another in order to enforce strong patent protection. 

>  

> 5. The present focus on counterfeit drugs and the Anti-counterfeit

Trade Agreement (ACTA) is the latest in the strategic forum shifting

by the US, EU and themultinational drug industry to ensure strict

enforcement of intellectual property rights (IPRs).

> 6.  WHO has developed the following definition of

counterfeits.  " 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 correct ingredients or with the

wrong ingredients without ingredients, with insufficient active

ingredients, or with fake packaging " .

> 7. In the WHO definition, counterfeits clearly apply only

to " mislabelling " of medicines and only to those situations in which

the mislabelling is carried " deliberately " and " fraudulently " . 

Thus it excludes those situations in which there are legitimate

disputes about the trade mark status of a label and the burden of

proof is with the accuser.  On the other hand IMPACT (International

Medical Products Anti-counterfeiting Task Force) a WHO initiative,

gives " new definition " of counterfeit medical product.  A medical

product is counterfeit when there is a false representation in

relation to identity, history or source.  This applies to the

product, its container or other packaging or labelling in

formations.  Counterfeits can apply to both branded and generic

products.  Counterfeit may include products with correct

ingredients/ components, with wrong ingredients components, without

active ingredients with incorrect amount of active ingredients or

> with fake packaging " , by avoiding the terms, " deliberately and

fraudulently " relieving the investigators of the onus of proving

voluntary possession of counterfeit medical products and

transferring the burden of proving their good intentions on those

found in possession of counterfeits.  This is a traversity of the

normal forms of justice where the guilty person has to prove he is

innocent and not guilty. 

> 8. Member States should ask the WHO why IMPACT, changed its

original definition.  The new definition is designed to assist MNCs

to get their IPRs strongly protected.  On the other hand the

developing countries will face more problems to get access to life

saving drugs.

> 9. WHO appears to initiate IP enforcement through its initiative

IMPACT which is supported by the International Federation of

Pharmaceutical Association (IFPMA), representatives of WTO, WIPO,

OECD and Interpol. 

> 10. IMPACT tends to be industry oriented and to blurs the

distinction between counterfeits on the one hand and generics,

parallel trade and compulsory licensing which are legitimate

business practices, on the other. 

>  

> 11. The strategy behind the whole issue seems to be to casually

mix every thing together including piracy, compulsory licensing,

parallel imports and generics under the single banner of the emotive

term " counterfeit " use it to frighten consumers, harness the power

of public health safety concerns, link it with IP protection and

enlist public sector support in enforcing private rights meaning

that taxpayers dollars would be used to protect private rights

> 12. The presentation Dr V Reggie of WHO Geneva gave to WHO/SEARO,

New Delhi on 7th August.  The presentation was

entitled " Counterfeits Kill! "   The graphic shows a venomous hooded

cobra ready to strike!  This will certainly frighten consumers. 

However, it is not factually correct.  The two definition

of " Counterfeit " given in the presentation includes medicines with

the correct ingredients.  These counterfeits will certainly not

kill.  Therefore a sweeping title is misleading; another statement

refers to " the 'perfect copy' myth without defining what a perfect

copy is.  This is blatant thinly veiled attempt to equate generics

with " perfect copy " and thereby call quality and safety of generics

into question.  Another department in the WHO actively promoted the

use of generics.  When experts within WHO disagree where do the

general public go?

> 13. The presentation quite correctly, states that not all

substandard drugs are counterfeit.  Therefore a system to monitor

infringement of IPRs and to strictly enforce patent protection to

keep counterfeits out of the market can never weed out all

substandard drugs from this market.  It is also accepted that

strict enforcement of IPRs will reduce access to life saving

drugs.  

> 14. To remove counterfeits, the best solution is to remove the

cause.  In developing countries, counterfeits enter the market

because of the lack of required drugs.  The solution to counterfeit

is, therefore, for the government to ensure the availability of the

required supply of needed drugs at affordable price by implementing

the new WHO Global Strategy and Plan of Action on Public Health

Innovation and Intellectual Property approved at the WHA in May

2008.  This should be the priority for the WHO not to redefine

counterfeit and call counterfeit a killer.

> Well, well the issue seems to be getting clearer now.

> Let us have the debate on this till Ram picks up the moderation of

his topic.

>

> Dr Vijay Thawani

>

>

>

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