Three new draft documents from the World Health Organization programme on intellectual property and innovation obtained by Intellectual Property Watch provide new evidence on how technology transfer is working, analyse research prioritisation at the WHO, and indicate progress on a monitoring and evaluation strategy for the programme’s continued implementation, according to a preliminary reading.

These documents are expected to be discussed at the upcoming World Health Assembly 17-21 May. [Update: WHO has now made these documents public. The documents are available at the site of the new Global Strategy and Plan of Action Monitoring and Evaluation Platform here, and are also linked directly below.]

Technology Transfer

Patents have a “variable impact on local production,” depending on country, area of medicine, and current capacity, says a document entitled “Improving Access to Medicines in Developing Countries through Pharmaceutical Related Technology Transfer: Preliminary Findings on Capacities, Trends, Challenges and Opportunities.”

It is available here [doc].

The document is a synthesis of three studies – two by Frederick Abbott, Florida State University law professor, and one by Suerie Moon, a research fellow at the Harvard University Kennedy School of Government. The studies were conducted in late 2009 under the European Commission project on Improving Access to Medicines in Developing Countries through Pharmaceutical Related Technology Transfer.

The three documents are expected to be publicly released shortly by WHO. There also is expected to be another one on intellectual property.

Capacity for pharmaceutical production in the developing world is currently limited to a small number of countries, but there is a diverse array of initiatives underway to increase both capacity and technology availability for the end goal of building local pharmaceutical manufacturing sectors, said the paper.

And the production of active pharmaceutical ingredients in the developing world is overwhelmingly concentrated in India and China, with other developing country producers of medicines often dependent on these countries to supply their own drug manufacturing processes, it said.

On intellectual property, there is plenty of literature analysing the impact of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights on production in India, where “it is apparent” that the ability to produce newer, patented drugs “is rapidly narrowing, with serious consequences for public health in India and the many developing countries to which Indian firms export generic drugs.”

However, remaining flexibilities with regards to international intellectual property rules in least developed countries (LDCs) have suddenly made them interesting candidates for pharmaceutical production, creating interest in an opportunity for technology transfer, the paper says. LDCs are exempt from implementing TRIPS until 2016. Interest in these areas is focussing on places such as Bangladesh, Uganda and Ethiopia, it says.

But many LDCs have not yet taken advantage of this space, and given the limited time before the 2016 implementation deadline, there may not enough room for the real development of pharmaceutical industries in these countries.

And there is “no clear consensus on if, how or under what conditions local production and technology transfer may improve access to drugs and vaccines” it says, and “in the absence of clearly-articulated international goals with respect to local production” there is no way to measure if these initiatives are enough.

An up-to-date database of relevant projects is “currently lacking but sorely needed” the paper says, to aid needed research into what kinds of policies are likely to spur technology transfer for drug access.

What transfer has been done so far has often been disease-specific – focusing on key areas such as influenza, HIV/AIDS, tuberculosis or malaria, the study says, adding that there is “ample opportunity and, arguably, a need to explore” technology transfer for a “broader spectrum of products,” including chronic diseases.

Whether transfer is useful depends on what is being offered and what the recipient can absorb, the paper adds. If those holding technology and those wanting access to it could be future competitors, it may be difficult to incentivise useful transfer in the private sector, it says. So public interest actors may “need to play a stronger role in providing incentives for sharing.”

Implementing the GSPOA

Meanwhile, a comprehensive revamping of the WHO’s work on Public Health, Innovation and Intellectual Property is happening under the auspices of a global strategy approved at the World Health Assembly in May 2008.

To coordinate this strategy, which involves a variety of stakeholders both internal and external to the WHO, a way to monitor and evaluate work being done was necessary. To this end, the WHO Department of Public Health, Innovation and Intellectual Property (PHI), which is overseeing the implementation of the strategy, initiated three parallel processes.

These processes are: mainstreaming implementation activities inside WHO (including identifying different departments to implement different elements of the strategy); facilitating national and regional implementation plans and monitoring systems; and building a reporting system to receive feedback coming from different sources, according to a document on monitoring and evaluation under the global strategy.

The document is available here [doc].

Possible challenges to the strategy implementation in the future include: that tracking information is a major effort that might be constrained by capacity in different countries, and that data currently available is limited; that many of the global strategy’s action points are vague, including objectives, and missing a structure; and financial constraints, the document says.

Health Research Prioritisation

The final document, “Health research prioritization at WHO – an overview of methodology and high level analysis of WHO led health research priority setting exercises,” is a review required by the global strategy on the WHO’s work around research and health. It aimed to provide a description of the different methods used to set research priorities within the organisation and to try and find common areas that lead to effective prioritisation. It evaluated 230 projects.

Among the paper’s conclusions was that the WHO has a “wide variety” of exercises related to research priorities, primarily in the areas of infectious and communicable diseases, with no clear standard for best practices. As an attempt to provide guidance on good practices, the WHO developed a “checklist for health research priority setting,” which was presented at a seminar 30 March, and then again at a May meeting of the Advisory Committee for Health Research, the document says.

Further details and options for next steps can be read in the full document. [Update: a newer draft of the document is available as of August 2010, and is available here [pdf].