E-DRUG: BMJ - Patent wars: affordable medicines versus intellectual property rights (3)
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[there was an earlier, even more informative article of Financial Times reporter Andrew Jack in the BMJ that also provides references to the original documents. Copied as fair use. WB]
http://www.bmj.com/content/348/bmj.g1377
Feature
Pharmaceuticals
Drug patents cause fresh spat between South Africa and industry
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g1377 (Published 7 February 2014)
Andrew Jack, deputy editor, analysis
Financial Times, London, UK
andrew.jack@ft.com
An embarrassing leak of the drug industry's lobbying plans against patent reforms has led to cries of 'genocide' from South Africa's health minister. Andrew Jack reports from Cape Town
Nearly 15 years after the pharmaceutical industry was accused of unwisely picking a fight with Nelson Mandela over affordable access to medicines, it is at the centre of a fresh spat concerning patents in South Africa.
Last month, Aaron Motsoaledi, the health minister, accused drug companies of 'genocide' after seeing their plans to campaign against draft government proposals on intellectual property reforms. â'This document can sentence many South Africans to death' he told the Mail & Guardian.1
The inflammatory rhetoric has made industry executives and even some activists squirm, yet it comes against the backdrop of spring elections in which the ruling African National Congress is fighting to retain its political dominance.
It also reflects a broader international battle over intellectual property rights, pitching industry claims that tougher patent rules will encourage investment and innovation against patient organisations, which argue that they restrict competition and keep prices unaffordably high.
The latest feud has already had repercussions for industry, with Novo Nordisk, the Danish diabetes focused drug company, and Roche of Switzerland both resigning their membership of the Innovative Pharmaceutical Association of South Africa (Ipasa), the industry trade body.
The reason for Motsoaledi's comments was a leak in the local media of plans for a $600â 000 (£370â000; â¬440â000) lobbying campaign to prevent damage to innovation during 2014 on behalf of Ipasa and PhRMA, the US drug company association.2
Motsoaledi's reaction recalled the conflict at the turn of the century, when similar battles over patents in the South African courts spilled into a vocal debate over affordable access to antiretroviral medicines for HIV, in a country with one of the highest prevalences and 'at the time-lowest treatment rates.
Public Affairs Engagement (PAE), a US lobbying firm, argued in its document submitted to Ipasa that: 'South Africa is now ground zero for the debate on the value of strong IP [intellectual property] protection.â It claimed that recent government proposals would undermine investment and fail to tackle the reasons it saw as explaining the poor health system: âsubstandard public health policy, an inadequate delivery system and poverty.'
Its pitch followed publication by the country's Department of Trade and Industry last September of a long awaited set of proposals that includes compulsory licensing to overturn patents, parallel imports (the import of medicines from other countries where they are sold more cheaply, usually from pharmacies rather than manufacturers), more detailed scrutiny of patent applications, and a switch in responsibility to companies to defend any patent challenges.3
Industry executives expressed frustration that the government had refused to discuss the proposals. They also argued that the proposals sat awkwardly with a separate innovation policy document issued in January by the Department of Science and Technology.4
Some local non-governmental organisations, including Medecins sans Frontieres, the Treatment Action Campaign, and Section 27, point out that some of the new proposals merely reiterate the current legal position (including the legality of compulsory licences under World Trade Organisation rules) or bring South Africa into line with other countries (such as the higher level preapproval scrutiny of patents in Europe and the US).
They point out that the current intellectual property rules - which industry believes would be weakened by the current proposals - have not led to significant increases in investment in local research or manufacture.
Industry tactics
There was nothing illegal in the PAE lobbying pitch, but it provided an unusual insight into lobbying tactics. The consultancy planned to create a new alliance called Forward South Africa to be led by âa respected former government official, business leader, or academic.â
The alliance would in turn fund an academic paper - commissioned by independent institutions - to make the case for the importance of strong intellectual property rights in 'encouraging wealth'. There would be opinion articles in the media and efforts to 'amplify the voices of development experts.'
An accompanying leaked email from the head of the South African subsidiary of Merck in the US to his local counterparts, said that PAE had been selected to run the campaign, with the aim of rapid implementation to delay the government's proposals until after the elections.
Drug company executives in Europe and the US have since tried to distance themselves from the PAE campaign, arguing that they had not approved it and would not do so.
They have been embarrassed by the leaks, particularly since some companies have separately been examining a broader series of potential reforms designed to improve affordability and access to medicines in lower income countries, with plans to arrange pilot programmes to test different models.
The tensions are acute at a time when industry is keen to expand into emerging markets, notably countries like South Africa where there is growing demand for medicines from middle class consumers. Yet growing pressure for a more widespread, equitable health system is fuelling continued concerns over affordability.
Elsewhere, India has recently rejected patents on Novartis's cancer drug imatinib and issued a compulsory licence for Bayer's cancer treatment sorafenib. Patient advocates have also recently filed a lawsuit seeking to block the granting of patents for sofosbuvir, Gilead's new treatment for hepatitis C.
Whether or not a lobbying campaign proceeds in South Africa, industry executives locally will be hoping that the government delays any final decision on patent revisions until after the volatile election period. But the debate of ideas has already been escalated far beyond the control of the local subsidiaries. It resonates around the world.
Notes
Cite this as: BMJ 2014;348:g1377
Footnotes
Competing interests: I have read and understood the BMJ policy on declaration of interests and have no relevant interests to declare.
Provenance and peer review: Commissioned; not externally peer reviewed.
References
01. De Wit P. Motsoaledi: big pharmaâs âsatanicâ plot is genocide. Mail and Guardian2014 Jan 17. http://mg.co.za/article/2014-01-16-motsoaledi-big-pharmas-satanic-plot-is-genocide.
02.Public Affairs Engagement. Campaign to prevent damage to innovation from the proposed draft national IP policy in South Africa. 2014. http://cdn.mg.co.za/content/documents/2014/01/16/skmbt36314011511040.pdf.
03.South African Department of Trade and Industry. Draft national policy on intellectual property. 2013. http://ip-unit.org/wp-content/uploads/2013/09/DRAFT-IP-POLICY.pdf.
04.South African Department of Science and Technology. The bioeconomy strategy. 2013. www.gov.za/documents/download.php?f=207579.