IP Rights Must Remain Distinct From Fake Medicines Policy At WHO, Members Warn

Intellectual property issues emerged at the World Health Organization Executive Board today as members discussed fake and substandard medicines, with some countries saying that the fight against such medicines should not serve as a pretext to enforce intellectual property rights and prevent access to safe generic medicines.

The WHO Executive Board (EB) is meeting from 26 January to 3 February. It is composed of 34 members.

EB members today were expected to note the report [pdf] of the third meeting of the member state mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products (SSFFC), which met in Geneva from 29-31 October 2014.

According to the report, the member state mechanism requested that the annual World Health Assembly (held in May) postpone the review of the mechanism by one year. This was also requested by several WHO members today. The EB took note of the report and agreed that the examination of the mechanism by the WHA would be postponed by one year.

The member state mechanism (MSM), according to the WHO report, reviewed the outcome of the technical meeting on recommendations for health authorities to detect and deal with actions, activities and behaviours that result in SSFFC medical products. Annex 2 details those activities, in particular quality monitoring and control in the supply chain, and alerts from track and trace systems.

Annex 2 of the document is a proposal by India and deals with activities and behaviours that fall outside the mandate of the mechanism, which were also reviewed by the mechanism.

Such activities include: activities in violation of laws other than medical product regulations, like actions in conflict with taxation, duties, and custom laws; activities related to the protection or infringement and enforcement of intellectual property rights, including data exclusivity. Activities also include the case of medical products in transit that are in compliance with the regulatory requirements of the country of export and the country of final destination, which may not be in compliance with the regulatory requirements of the country in transit. The paragraph describing this activity is heavily bracketed.

Nations: SSFFC Fight Not About IP Enforcement

The activities described in Annex 2, on which consensus could not be reached during the last meeting of the mechanism, prompted statements today from countries wanting to draw a firm line between public health requirements and what they perceived as being attempts at enforcing IP rights to the disfavour of the public interest.

Brazil said in its statement that “the point that refers to in-transit medical products and which did not achieve consensus during MSM’s [member state mechanism] last meeting should be better analysed and discussed by countries, given the importance of the initiative, since the seizure of generic drugs in-transit led to the establishment of the MSM itself.”

“It is important to stress the concern about the handling of issues related to SSFFC in areas outside WHO, given the need to protect the public health perspective to the detriment of other interests,” the Brazilian delegate said. “Brazil underscores the need to focus the debate on the concern about health aspects of medical products and not the protection of intellectual property or criminalization, when the matter at hand is the public health perspective.”

Uruguay for the Union of South American Nations (UNASUR), said the UNASUR nations have set up mechanisms to deal with the problem of fake and substandard medicines from a public health perspective excluding consideration linked to trade and intellectual property. The prevention and fight against SSFFC should not reduce access to safe and effective generic drugs, the Uruguayan delegate said. Medical products meeting the health standard of exporting and importing countries must not be submitted to any question by third parties when in transit, he said.

India in its prepared statement, said, “The mandate of the MSM (as defined in WHA resolution 65.19) clearly excludes any IP or trademark considerations.”

“However,” said the delegate, “in the absence of a common understanding of the term SSFFC, there is a real and persistent danger of alleged IP infringements to be equated with substandard/spurious medicines. This can undermine the very basic objective of the Mechanism, which is to ensure access to safe, affordable and quality medical products while preventing the menace of substandard and spurious drugs.”

Commenting on the inability to agree on its proposal, India said it is concerned “with the positions of some countries that are determined to justify their assumed rights to intercept access to genuine affordable medicines using the pretext of SSFFC medical products,” and added that “certain member states” were pushing “their agenda in other UN fora, which can undermine the progress achieved within WHO’s MSM.”

A number of countries underlined the need to strengthen health care and regulatory systems to address the problem of fake and substandard medicines. Several developing countries stressed the need for capacity building at national level, and for surveillance and monitoring systems.

Some developing countries also said that the high price of medicines is hampering the fight against SSFFC.