Don’t mix IP issues with fake drugs, WHO asks MNC drug makers

WHO South Asia region rejects agenda to stop generics exported from India branding them as fake and counterfeits

Fake, substandard and counterfeit drugs issue needs to be separated intellectual property (IP) enforcement, the World Health Organisation (WHO) said, rejecting the counterfeit drugs agenda giving a major blow to the developed countries and pharma MNCs.

Counterfeit is an intellectual property right (IPR) issue and should not be linked to quality and efficacy of medicines, WHO said in a resolution passed in its annual forum, the south-east Asia region  on September 10.

WHO has made it clear that it does not support IP policies that could potentially undermine availability of safe and affordable medicines to the people in developing countries like India.

Developed countries and MNCs are attempting to confuse intellectual property (IP) enforcement issues with trade and substandard drugs, so there is a need to separate IP issues from availability of safe, efficacious and quality drugs.

Pharma MNCs has been threatening the entry of legitimate generics exported from India under the garb of fake and counterfeits.

Recently, several drug shipments meant for some developing countries from have been confiscated in European ports saying that they violated the IP rights of the countries through which the cargo passes.

Indian government has taken up the matter to the European countries involved in confiscation as well as to World Trade Organization (WHO).

This has huge ramifications particularly for India as consignments of generics have been seized while in transit in Netherlands and other European countries, on allegations of IP infringement.

WHO has created a global coalition of stakeholders called IMPACT (International Medical Products Anti-Counterfeiting Taskforce) to tackle the challenge of fake and counterfeit drugs.

IMPACT  taskforce, created in 2006, has been active in forging international collaboration to seek global solutions to this global challenge and in raising awareness of the dangers of counterfeit medical products.

IMPACT aims to coordinate across and between countries in order to halt the production, trading and selling of fake medicines around the globe. IMPACT is a partnership comprised of all the major anti-counterfeiting players, including: international organizations, non-governmental organizations,
enforcement agencies, pharmaceutical manufacturers associations and drug and regulatory authorities.

South-east Asia countries like India and Thailand had opposed the IMPACT Agenda in the World Health Assembly last year, as well as in the WHOs executive board meeting earlier in January this year.

India and other developing countries have been concerned that IMPACTs focus on policy and legislation on counterfeit drugs will be counter productive and will create barriers to trade in and access to legitimate medicines.

On the issue of counterfeits, WHO has urged member states to strengthen their national regulatory framework to ensure access of safe, quality and affordable medicines to all, particularly vulnerable groups.

WHO also asked for incorporating of public health safeguards, as mandated by the Doha Declaration on the TRIPS agreement and public health, in the states domestic intellectual property legislation.

WHO’s member atates should implement trade and intellectual property policies without constraining policy space on health, including access to safe, efficacious and quality and affordable medical products.

The counterfeiting of medicines has been a problem for at least two decades in many countries around the world. As international markets expand and become globalized the problem has extended to all countries and regions; even though it remains more prevalent in developing countries. The increase in the commercial use of the Internet has also contributed to a growth of the problem as many fake products are sold illegally on unauthorized web sites, WHO says.