Critics of 'me-too' innovation often argue that follow-on drugs offer little incremental clinical value over existing pioneer products, while at the same time increasing health care costs. This study examines whether consumers view follow-on and pioneer drugs as close substitutes or distinct clinical therapies. For five major classes of drugs, it found that large reductions in the price of pioneer molecules after patent expiration – which would typically lead to decreased consumption of strong substitutes – have no effect on the trend in demand for follow-on drugs. The findings are likely unaffected by health insurance, competitive pricing of me-toos, marketing, and switching costs.
Health equity in economic and trade policies
‘Me-too' innovation in pharmaceutical markets
Jena AB, Calfee JE, Mansley EC and Philipson TJ: Forum for Health Economics & Policy 12(1): Article 5, 2009
Access to safe medicine a public health issue, not IP, says panel
Saez C: Intellectual Property Watch, 4 October 2009
Anti-counterfeiting initiatives might have a negative impact on access to medicines while not addressing the problem of fake medicines, particularly in developing countries, says a panel, which met on 25 September at the World Intellectual Property Organization General Assemblies. Confusion between legitimate generic medicines, poor quality medicines and those illegally copying the trademark of a brand-name product could have a devastating impact, and a precise definition and scope of counterfeiting is needed, they said. IP enforcement measures should only be used against drugs with trademark violations. Counterfeit medicines are products that are packaged to intentionally look like a legitimate product but are not. This is a trademark infringement. On the other hand, substandard medicine is a legitimately produced medicine that does not meet the standards set by the relevant drug regulatory authority. This is an issue of quality control. ‘When we speak about anti-counterfeiting initiatives, we are basically referring to the global IP enforcement agenda,’ Sangeeta Shashikant, senior legal advisor at the Third World Network, said at the meeting.
Assessing regional integration in Africa 3: Towards monetary and financial integration in Africa
Economic Commission for Africa: 2008
From the 1960s to the present, many African integration groupings have emerged and faded away. Within the various integration groupings, the development of trade has been a major objective pursued through programmes aimed at achieving a free trade area, a customs union and a common market. But outcomes of decades of experimentation with integration in Africa have on balance remained modest. For instance, African trade statistics continue to paint a generally modest picture of trade between regional economic communities (RECs), as well as intra- African trade. The countries generally lack a strong industrial capacity to produce diversified manufactured goods for trade within regional markets. Many of the multiple national currencies in Africa lack convertibility and efforts towards monetary, financial and physical integration have not been very promising. The cost of doing business in the continent is generally high, due in part to infrastructure gaps, duplicative border procedures and cumbersome paper requirements. Paperless trade still remains a distant objective. The free movement of people and the right of establishment have progressed in some RECs, but remain a paper objective in many other African subregions.
Can WIPO ‘move forward with the tide of history’?
Mara K: Intellectual Property Watch: 30 September 2009
At the end of the World Intellectual Property Organization (WIPO) General Assemblies, held from 25–30 September 2009, frustration at the lack of consensus was palpable, especially among developing countries calling for a legally-binding international instrument. ‘We believe our countries are being treated unfairly,’ said a delegate from Burundi during the plenary session, in reference to the fact that there is as yet no international instrument to protect traditional knowledge and genetic resources. ‘The [WIPO] Secretariat is an arbiter and should intervene,’ he added. But others questioned the legally binding instrument as an outcome. Korea suggested in plenary that ‘perhaps we can prevent misappropriation without proprietisation,” and suggested looking at options to protect traditional knowledge and genetic resources within the existing system, and several developed countries said a renewed mandate should not commit to a specific outcome. Botswana and Zimbabwe mentioned efforts through the African Regional Intellectual Property Office (ARIPO) to create a regional instrument, while Ecuador spoke of creating a national biodiversity and traditional knowledge database that would include sui generis protection measures.
Cholera forcing: The myth of the good epidemic and the coming of good water
Hamlin C: American Journal of Public Health 99(11): 1946–1954, November 2009
It has been frequently claimed that cholera epidemics, both in the 19th century and today, were and can be the key stimulus for procurement of safe water and sanitation, an idea that the author calls ‘cholera forcing’. ‘Technology forcing’ refers to imposition of exogenous factors that suddenly make possible achievements that had not seemed so; cholera has been seen in this light. He argues that this view oversimplifies and under-represents the importance of industrialisation in securing water supplies. Careful study of the financial, political, and administrative foundations of such changes will be more fruitful.
Counterfeit, substandard and generic drugs: Distinct definitions for distinctly different problems
Medicin Sans Frontiers: April 2009
Today there is a real attempt by certain actors to confuse the debate about substandard, counterfeit and generic drugs. Articles in the media often discuss counterfeit, substandard and generic medicines as if they are all one problem and the same solution can be used for all of them. This confusion can have a negative impact – because if the public believes that generic medicines are the same as counterfeit medicines, they will lose confidence in generic medicine. Another negative consequence of confusing counterfeit and generic drugs, is that this often leads to calls for stronger intellectual property enforcemement, which then creates access to medicines problems. Even at the level of policy makers, these confused messages can have a very negative effect. The World Health Organization (WHO) has a role to play in supporting national regulators to take measures against both counterfeit and substandard medicines. But, perhaps most importantly, WHO should shift its attention to substandard medicines, a much bigger problem.
Draft decision emerges from World Intellectual Property Organization General Assemblies
World Intellectual Property Organization General Assemblies: 1 October 2009
After a year of stalled deliberations on the issue of protecting traditional knowledge, genetic resources and traditional cultural expressions, delegates at the World Intellectual Property Organization General Assemblies on 1 October found a compromise text that gives the committee its strongest mandate yet. The new Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) agreement is to undertake text-based negotiations that will eventually become an ‘international legal instrument (or instruments)’ to ‘ensure the effective protection of’ traditional knowledge, genetic resources and traditional cultural expressions (folklore). It also lists three texts – containing language in the format of a possible draft instrument – that will form the basis of those negotiations, though it does not limit negotiations to just those texts. It also says there will be three inter-sessional working groups during the next biennium to accelerate the work.
G20: One voice for all?
Collodi J: 30 September 2009
It caught observers and analysts by surprise. The Pittsburgh G20 summit witnessed the death-knell of the G8 as the sole arbiter of global economic policy and the transference of power to the G20 grouping. Officially this will take place at the G20 summit at the end of 2010 in South Korea, as Canada – in perhaps an unwelcome reminder of parochial G8 decision-making –is keen to keep ‘its’ G8 event as relevant as possible. The author argues that the G8, after much debate over its futility as a global decision-making body, is consigned as a forum to consider security matters. But the G20 counts just one African nation as a member. Although developing countries such as India, Brazil and South Africa have more authority to speak on behalf of poorer nations, the voices of low-income countries themselves were not included or seemingly solicited. ‘One of the most important successes of Pittsburgh is that that the G20 is the most qualified forum to deal with global issues,’ African Development Bank president Donald Kaberuka said, speaking on the periphery of a conference. ‘(However) (t)he way it is now structured...the low-income countries' priorities are still an appendix, a footnote.’
Kenyan court case holds up national ARV supply
Plus News: 12 October 2009
Kenya is facing a nationwide shortage of anti-retroviral (ARV) drugs after a court case held up the purchase of the life-prolonging medication. The High Court in the capital, Nairobi, barred the Ministry of Health from procuring ARVs after a consortium of drug suppliers challenged the tender process earlier this month. According to James Ole Kiyapi, permanent secretary in the Ministry of Public Health, unless the court allows the government to purchase ARVs, there is a real risk that people who depend on government hospitals for their medication could go without. ‘We have very little medicine left and there is nothing we can do to get the drugs because we have to abide by the court order; we can do very little at the moment unless the court reverses the order,’ he said. Earlier this year, the Public Procurement Review Board (PPRB) – responsible for monitoring the government's purchases – issued an order forcing the Kenya Medical Supply Agency (KEMSA) to accept tender documents by an Indian company, Hetero Drugs Limited, and start the tender process afresh. KEMSA had rejected the company's tender documents because they allegedly did not comply with procurement rules. The consortium that originally won the controversial tenders has now gone to court to reverse the order of the PPRB.
The global politics of pharmaceutical monopoly power
Hoen EFM, Medecins Sans Frontieres : 2009
Many countries have been able to use the TRIPS flexibilities to access lower-priced generic drugs. However, as pharmaceutical product patents start to be granted in producing countries, this situation will change. To resolve the problem of high drug prices caused by patent monopolies, this book recommends that developing countries should make full use of the provisions in the Doha Declaration. It introduces a re-conceptualised definition of innovation as encompassing discovery, development and delivery, thereby including access as an integral part of innovation. Equally important, the international community should consider supporting patent pools as a tool for improving the management of intellectual property for access and innovation. In this sense, the book suggests a new agreement on sharing the costs and benefits of medical research and development (R&D) for the sake of humankind. In like manner, the book underlines a proposition to change the way R&D is financed. At the core of this proposal is the elimination of the linkage between drug prices and drug discovery. It also highlights the importance of establishing a trade framework for R&D that focuses on equitable contribution to the cost of R&D through multiple means – not exclusively through the granting of patent monopoly rights.