WHO, WTO, WIPO Combine Forces To Improve Patent Information For Public Health

Patents and public health are sometimes seen as a mismatch, but three prominent international organisations today stepped up their collaboration on ways to facilitate access to medicines by making a better use of the patent system. Effective, reliable and transparent information on patents is necessary to help decision-makers take the best public health approaches for global health coverage, panellists said.

“Public health now finds itself caught in a cross-current of rising expectations and ambitions, set against rising demands and costs, at a time when funds are stagnant or shrinking,” said World Health Organization Director Margaret Chan. “In such as situation, introducing greater efficiency is a far better option than cutting budgets and services.”

The technical symposium on “Access to Medicines, Patent Information and Freedom to Operate,” was hosted by the WHO and co-organised by the World Intellectual Property Organization, and the World Trade Organization.

Chan said that public health needs innovation and access to good quality medical products, but current economic circumstances have led governments to “look at the efficiency and the fairness of their health services,” including the question of affordable medicines, like generic medical products.

Hard-won progress in public health over the last century is in danger of stalling, she said. Chronic noncommunicable diseases are shifting towards developing country populations with 80 percent of diseases like cardiovascular diseases, hypertension, diabetes, and cancer now found in low and middle-income countries. Chronic treatments must be made more affordable, Chan said.

According to last year’s World Health Report, “countries could save about 60 percent of their pharmaceutical expenditures by shifting from originator medicines to generic medicines,” she said, but a lack of essential procurement and regulatory capacities are preventing this shift in many developing countries.

The globalisation of patent protection and the protection of intellectual property on medicine through the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), are putting an extra burden on health officials seeking to trim their budgets through lower-cost generic products because they now have to consider patents’ status, Chan said.

More transparent and accessible data on patents is necessary to help with decisions on the “freedom to operate”, she said, such as a user-friendly database which contains public information on the administrative status of health-related patents.

According to Francis Gurry, WIPO director general, one of the justifications of patents is the disclosure of technology, as it is the most systematic system of disclosure of the world knowledge. The disclosure function “did not really operate in the paper age,” he said, but digital technology and the internet has changed that, even in developing countries.

Pascal Lamy, WTO director general said the main target of the symposia was not to enter policy discussions or legal debates but rather to evaluate the area where the three agencies could collaborate to provide an information base for policy debates, he said.

WTO recognises that health innovation and access to medicine are at the top of the IP policy agenda, Lamy said, but it proves difficult for the organisation to solely refer to the TRIPS agreement and it needs information and guidance “by all”, as well as information based on empirical data. The first symposium, hosted by the WTO in July 2010, showed the vast potential for this empirical data to inform policy debates on health and access to medicine, he said (IPW, WTO, 19 July 2010).

In the context of the symposium, access to medicine refers to access to all health technologies, said Zafar Mirza of the WHO Department of Public Health, Innovation and IP. The determinants of access to health technologies are many and include rational selection, affordable prices, sustainable financing, and a reliable supply system, he said.

Access to patented essential technology is an issue, he said, as many medicines for communicable and noncommunicable diseases remain inaccessible to people in developing countries. New health technologies are under “relatively strong and prolonged patent regimes” introduced by TRIPS and further reinforced by free trade agreements, he said.

To make appropriate procurement decisions, to encourage local production of generic medicines and vaccines, to facilitate technology transfer, to undertake research and development and use TRIPS flexibilities, it is important to know about the patent status of technologies, Mirza said.

The aim of the symposium was to reflect on the area between access to patent-free essential health technology, which he called an important and unattended area, and access to patented essential health technology, he said.

A key point in the TRIPS agreement is the notion of the mutual advantage of producers and users of knowledge as stated in Article 7, said Antony Taubman, director of WTO Intellectual Property Division.

The requirement of the patent system is to be transparent and it should work as a source of technological information, he said. Common needs include moving from raw data to accessible trusted neutral and relevant information that helps policymaking processes, practical innovation, and procurement strategies.

Patent information includes the identification of patent holders, where the technology is patented or not, and this information has implications on research and development, procurement initiatives, and impacts future developments, Taubman said. It also helps policymakers explore issues, make assessments and set priorities, as well as make policy on health policy issues guided by a “richer information base,” he said.

An important issue is the territoriality and data asymmetries, he said, with countries for which data is critically needed being different from which countries where data is available.

Anatole Krattiger, director of Global Challenges Division at WIPO, said the organisation’s role is to encourage innovation capabilities of industry and public sector universities. IP is the principal driver of innovation, he said, characterising the freedom to operate as the capability to assemble all the IP rights attached to technologies.

Whether a patent is issued in a certain country is not a barrier per se to freedom to operate, according to Krattiger, adding that the most common way to obtain freedom to operate was through licensing, but in practice, a combination of several strategies implemented concurrently was best.

From the audience, Bill Haddad, chairman and CEO of Biogenerics, a generic pharmaceutical company, called for the greater involvement of the generic industry to provide affordably priced medicines, and said after Krattiger’s speech: “WIPO will never be our friend.”