TWN Info Service on Health Issues (Sept09/01)
28 September 2009
Third World Network

South-East Asian Member States reject IP enforcement agenda
Published in SUNS #6776 dated 22 September 2009
 
New Delhi, 18 Sep (K. M. Gopakumar) -- Moves to inject intellectual property rights enforcement into the World Health Organisation (WHO) have been rejected by eleven Asian countries in the preparations for the 2010 annual meeting of the World Health Assembly.
 
The Sixty-Second meeting of the South-East Asia Regional Committee of WHO that met from 8 to 10 September in Kathmandu adopted a resolution that clearly rejected the intellectual property enforcement agenda of pharmaceutical multinational corporations from industrialised countries.

Bangladesh, Bhutan, DPR Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste make up the WHO South-East Asia regional membership.
 
The resolution requests the Director of the WHO South-East Asia Regional Office (SEARO) to advocate that WHO as a whole does not support intellectual property policies that could potentially undermine the availability of safe, efficacious, quality and affordable medical products.

The regional committee meets annually to review the outcomes of the last World Health Assembly (WHA), discuss regional work programmes and prepare for the next Assembly meeting.
 
Since 2008, developing countries have been questioning the involvement of WHO in the International Medical Products Anti-Counterfeits Task force (IMPACT). During the January Executive Board Meeting, developing countries raised specific objections on the composition and the conflict of interest issues related to IMPACT (see SUNS #6623).
 
Again in the annual WHA in May this year, developing countries raised concerns over the use of the term "counterfeit" in WHO's Mid-Term Strategy Plan 2008-13. Responding to the concerns of developing countries, WHO Director-General Dr. Margaret Chan offered to drop the contentious term in favour of other terms such as "substandard".
 
Developing countries question WHO's emphasis on counterfeit medical products, saying that this undermines legitimate public health concerns such as falsely labeled, substandard and spurious products. According to developing countries, the use of the term "counterfeit" to address the safety, efficacy and quality of medical products would result in the enhancement of intellectual property enforcement standards rather than addressing the public health problems.

The South-East Asian regional committee resolution notes that the term and definition of "counterfeit" relate to infringement of intellectual property rights and should not be equated with substandard medical products. It then recognises the need to separate the issues of protection and enforcement of intellectual property rights from the availability, safety, efficacy and quality of medical products.

It expresses serious concern about the numerous incidents of intellectual property enforcement measures that have resulted in unwarranted seizures of generic medicines affecting the access to affordable medical products, and generic production in developing countries.
 
It takes note of the definition of "counterfeit trademark goods" in the WTO Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS): "any goods, including packaging, bearing without authorisation a trademark which is identical to the trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark, and which thereby infringes the rights of the owner of the trademark in question under the law of the country of importation."
 
Further, it also recalls the Doha Declaration on Public Health and the TRIPS Agreement that "the TRIPS Agreement does not and should not prevent Members from taking measurers to protect public health" and that "the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all".

The resolution urges Member States to refrain from applying measures to enforce IPRs, such as the seizure of medical products in transit, that result in creating barriers to legitimate trade and obstructing access to medical products, particularly in developing countries.
 
[Seizures by some European authorities of generic medicines from India en route via Europe to other developing countries in recent months have triggered diplomatic complaints and the ire of generic producers.]

It also urges Member states to implement trade and intellectual property policies without constraining policy space on health, including access to safe, efficacious, quality and affordable medical products.

Further, it urges the incorporation of public health safeguards, including as mandated by the Doha Declaration, in domestic intellectual property legislation.

The resolution also urges Member states to take measures to address barriers related to access to safe, efficacious, quality and affordable medical products and strengthen the national regulatory authorities by enhancing their capacity to ensure for all access to safe efficacious, quality and affordable medicines.

It also requests the WHO SEARO Regional Director to support the development of new techniques and test methods for the use of national drug regulatory authorities to ensure the quality of medical products.

The resolution emphasises the importance of ensuring access to affordable medicines, technologies and other health products among people in need while ensuring safety, efficacy and quality of medical products.

It expresses concerns about the reports of compromised safety, efficacy and quality of medicines and stresses the need to effectively address the availability of safe, quality and affordable medical products. It recognises the serious consequences of falsely labeled or substandard medical products on the health of the population. +

Published in SUNS #6776 dated 22 September 2009

 
New Delhi, 18 Sep (K. M. Gopakumar) -- Moves to inject intellectual property rights enforcement into the World Health Organisation (WHO) have been rejected by eleven Asian countries in the preparations for the 2010 annual meeting of the World Health Assembly.
 
The Sixty-Second meeting of the South-East Asia Regional Committee of WHO that met from 8 to 10 September in Kathmandu adopted a resolution that clearly rejected the intellectual property enforcement agenda of pharmaceutical multinational corporations from industrialised countries.

Bangladesh, Bhutan, DPR Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste make up the WHO South-East Asia regional membership.
 
The resolution requests the Director of the WHO South-East Asia Regional Office (SEARO) to advocate that WHO as a whole does not support intellectual property policies that could potentially undermine the availability of safe, efficacious, quality and affordable medical products.

The regional committee meets annually to review the outcomes of the last World Health Assembly (WHA), discuss regional work programmes and prepare for the next Assembly meeting.
 
Since 2008, developing countries have been questioning the involvement of WHO in the International Medical Products Anti-Counterfeits Task force (IMPACT). During the January Executive Board Meeting, developing countries raised specific objections on the composition and the conflict of interest issues related to IMPACT (see SUNS #6623).
 
Again in the annual WHA in May this year, developing countries raised concerns over the use of the term "counterfeit" in WHO's Mid-Term Strategy Plan 2008-13. Responding to the concerns of developing countries, WHO Director-General Dr. Margaret Chan offered to drop the contentious term in favour of other terms such as "substandard".
 
Developing countries question WHO's emphasis on counterfeit medical products, saying that this undermines legitimate public health concerns such as falsely labeled, substandard and spurious products. According to developing countries, the use of the term "counterfeit" to address the safety, efficacy and quality of medical products would result in the enhancement of intellectual property enforcement standards rather than addressing the public health problems.

The South-East Asian regional committee resolution notes that the term and definition of "counterfeit" relate to infringement of intellectual property rights and should not be equated with substandard medical products. It then recognises the need to separate the issues of protection and enforcement of intellectual property rights from the availability, safety, efficacy and quality of medical products.

It expresses serious concern about the numerous incidents of intellectual property enforcement measures that have resulted in unwarranted seizures of generic medicines affecting the access to affordable medical products, and generic production in developing countries.
 
It takes note of the definition of "counterfeit trademark goods" in the WTO Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS): "any goods, including packaging, bearing without authorisation a trademark which is identical to the trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark, and which thereby infringes the rights of the owner of the trademark in question under the law of the country of importation."
 
Further, it also recalls the Doha Declaration on Public Health and the TRIPS Agreement that "the TRIPS Agreement does not and should not prevent Members from taking measurers to protect public health" and that "the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all".

The resolution urges Member States to refrain from applying measures to enforce IPRs, such as the seizure of medical products in transit, that result in creating barriers to legitimate trade and obstructing access to medical products, particularly in developing countries.
 
[Seizures by some European authorities of generic medicines from India en route via Europe to other developing countries in recent months have triggered diplomatic complaints and the ire of generic producers.]

It also urges Member states to implement trade and intellectual property policies without constraining policy space on health, including access to safe, efficacious, quality and affordable medical products.

Further, it urges the incorporation of public health safeguards, including as mandated by the Doha Declaration, in domestic intellectual property legislation.

The resolution also urges Member states to take measures to address barriers related to access to safe, efficacious, quality and affordable medical products and strengthen the national regulatory authorities by enhancing their capacity to ensure for all access to safe efficacious, quality and affordable medicines.

It also requests the WHO SEARO Regional Director to support the development of new techniques and test methods for the use of national drug regulatory authorities to ensure the quality of medical products.

The resolution emphasises the importance of ensuring access to affordable medicines, technologies and other health products among people in need while ensuring safety, efficacy and quality of medical products.

It expresses concerns about the reports of compromised safety, efficacy and quality of medicines and stresses the need to effectively address the availability of safe, quality and affordable medical products. It recognises the serious consequences of falsely labeled or substandard medical products on the health of the population. +