WHO Restructures Medicines Department, Including Innovation, Policy

This summer through September, a restructuring is taking place under the World Health Organization Health Systems and Innovation cluster that has relevance for intellectual property and innovation issues.

The restructuring was explained in a recent Intellectual Property Watch interview with WHO Assistant Director General Marie-Paule Kieny.

As planned, the Medicines Department will be restructured into three “pillars”: innovation, policy, and regulation of medical products. The goal is to streamline efforts to achieve greater continuity, in order to fit in with the push for universal health coverage (UHC), because of the crucial role medicines play in achieving such coverage.

In the interview, Kieny said the objective is to account for all of the components along the continuum of medicine discovery and development, in order to bring together production, delivery, and control policies whilst simultaneously increasing access to current and new medicines.

Being able to control the cost of this part of the medicines “package” would also be a hugely important component of UHC. According to Kieny, the main objective of the Health Systems and Innovation (HSI) cluster is to facilitate the implementation of universal health coverage, and the fact that medicines are an important part of the cost of UHC necessitates WHO to have a continuum between innovation, policy, and regulation.

Currently, the HSI cluster is broken down into multiple departments, including Public Health, Innovation, and Intellectual Property (PHI); and Essential Medicines and Health Products (EMP).

Within EMP right now, there are two teams working on medicine policies (e.g., medicine access, governance, rational use, pharmaceutical country profiles), and a number of teams involved in medicines regulation. The restructuring will break the EMP department into two separate streams for policy and regulation.

Policy

With the restructuring, there will be a greater focus on strengthening medicines policy. Compared to a currently very strong Regulation department (largely due to the prequalification programme (PQP)), the policy area needs to be built up significantly, Kieny said.

The policy area will look at rational use of medicines and health technology assessment to make sure country-specific and country-appropriate packages are developed, and the focus is not just on finding a minimum standard. To do so, there must be rational decision-making instead of relying on chance or lobbying.

Regulation

The Regulation department will continue its work on PQP, and will also look to scale up programmes at country level by strengthening national regulatory authorities to look at the quality of products on the market. With the restructuring, the activities under the Regulation pillar will take best practices from programmes that were developed separately for medicines and diagnostics in the past, and move toward a single approach at WHO for regulation of medical products and prequalification, Kieny said.

Innovation

The third stream will be innovation, which will include what is currently the PHI department (coordinated by Zafar Mirza), as well as technology transfer and local production teams. This area will focus on ensuring new products come to market, especially in areas where there are market failures and lack of innovation.

This section of the WHO medicines area will look at conditions that might allow for successful translation of domestic local production into increased access. Kieny said that local production does not always favour access, and while there are many reasons to promote local production, the goal is to make sure it benefits the people in these countries.

“There has been discussion of local production overlapping between different departments,” Kieny said, and thus there is a need to “move towards advising on the same policy, the same approach.”

“It is not helpful when different pieces of WHO here and there are working with different people on different streams, and not using the same approaches,” she added.

The innovation pillar will analyse what are the factors of success in terms of increased access to medicines, which includes aspects of intellectual property, the trilateral study done by WHO, WTO, and WIPO; and the WHO Global Strategy and Plan of Action (GSPOA) previously agreed by member states to find a solution to the lack of R&D for diseases disproportionately affecting poor populations.

Under the innovation pillar there also will be a small unit to conduct hands-on support and technology transfer, working with developing countries to bring innovators together.

With the restructuring, Kieny says the Medicines department “will be a bigger department,” but the only positions that will be open for internal recruitment will be the management leadership positions. She said that “sometimes it’s good to reorganise the way we do business … [but] this reorganisation is not meant, at all, to do downsizing.”

Kieny is hopeful that the WHO financing dialogue that was approved at the last World Health Assembly will help with the restructuring, by making clear what type of financing model the Medicines department will be working with.

“Being able to present transparently to the member states the funding situation of all these components,” she said, “we hope there will be an interest in this area of medicines, so that [member states] would take interest in making sure that the level of financing that we have on this is sufficient.”

An organigram of the current structure of WHO is available here.

A diagram of the WHO restructuring, created by IP-Watch intern Brittany Ngo, is shown below:

Brittany Ngo is currently completing her Master’s in Health Policy and Global Health at the Yale School of Public Health and previously obtained a Bachelor’s of Arts in Economics from Georgetown University. Through her studies she has developed an interest in health-related intellectual property issues. She is a summer intern at Intellectual Property Watch.