Friday, February 07, 2014

Big pharma in the dock over patent law plot in South Africa


Attempts to reform South Africa's patents laws have been marred with controversy over an alleged campaign by big pharma to derail the process. Adele Baleta reports from Cape Town.

A heated row between the South African Government and the country's umbrella organisation for drug companies over a proposed publicity campaign to fight draft patent reforms has gained momentum with Danish company Novo Nordisk quitting the group in protest.

The company is one of 26 research-based pharmaceutical companies who are members of the Innovative Pharmaceutical Association of South Africa (IPASA), which recently sent an email to members seeking support for a US$541 000 campaign aimed at challenging efforts to overturn current intellectual property (IP) legislation.

Among other issues, South Africa's draft IP law seeks to address patent ever-greening, a contentious strategy in which drug firms tweak formulations to extend the 20-year life of a patent.

Novo Nordisk resigned from IPASA with company spokeswoman Shelley Harris writing in an email that the decision to leave followed “a disagreement on a public relations campaign proposed by IPASA, which we felt did not serve our or the industry's interests”.

Non-governmental organisations (NGOs) Treatment Action Campaign (TAC) and Médecins Sans Frontières have slammed the “covert” campaign and they will continue with their Fix The Patent Laws initiative, which is rallying to amend South Africa's Patents Act 57 of 1978 to reduce the cost of medicines in the country. As well as antiretroviral treatment for HIV/AIDS, the NGO campaign targets expensive therapies for cancer and multidrug-resistant tuberculosis for which there are no current alternatives in the country.

The IPASA email came to light after a nine-page document was leaked to the media detailing a plan prepared for IPASA by Washington-based firm Public Affairs Engagement (PAE), urging pharmaceutical companies to campaign against the Proposed Draft National Intellectual Property Policy in South Africa.

The document suggests that PAE intends to run a persuasive campaign in Africa and in Europe, which includes setting up a South African organisation to lobby against the policy that would seem to be a local movement but would be operated from the USA.

Health Minister Aaron Motsoaledi has been quoted as saying attempts to strengthen intellectual property rights in South Africa and to stall the new law could “sentence many South Africans to death”. He likened the PAE plan to a conspiracy of “satanic magnitude” that was tantamount to “genocide”. He told the country'sMail & Guardian newspaper that PAE was using South Africa as its starting point but ultimately it was also an attack on Brazil, India, China, Russia, and the developing world.

The email sent on Jan 10 by head of IPASA's IP committee Michael Azrak, who is also Merck's managing director for southern and east Africa, to members was also leaked to the media. Azrak said that the overall campaign was aimed at delaying the finalisation of the IP bill until after the 2014 South African general election as this would allow time to develop a third stage of the campaign: establishing a strong, comprehensive IP policy. Referring to PAE, he says in the email: “As we agreed at our last board meeting, we have moved ahead in identifying a high calibre consultancy group to work with us.”

A key aim, he wrote, was to: “Mobilize voices inside and outside South Africa to send the message that the proposed IP policy threatens continued investment and social well-being.”

IPASA subsequently denied that the plan had been adopted, but TAC's spokesman Marcus Louw told The Lancet Azrak “clearly expected it to go ahead and so did the IP committee of IPASA”.

In his email, Azrak calls for members to agree to the plan by Jan 15, but added if a response was not received by then, it would be assumed that members supported the plan. Comment from Merck in South Africa was unavailable at the time of going to press.

IPASA chief operating officer Val Beaumont told The Lancet that as far as she was aware none of the other members had signalled their intention to resign from the association. She said she would meet Novo Nordisk's CEO in the last week of January. “We hope not to lose a valued and respected member.” She indicated that IPASA had not engaged the consultancy PAE to lobby against the draft IP laws. She has consistently denied that IPASA was behind the plan but rather that PAE submitted the proposal, which was reviewed and subsequently rejected by IPASA members.

The PAE proposal comes 16 years after Merck and other companies failed in a court bid against Nelson Mandela and the South African Government on Feb 18, 1998, to override legislative reform to enable South Africa to get access to affordable life-saving drugs.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60160-4/fulltext?rss=yes

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