The World Health Organization has released a report on the role of intellectual property in local production of medicines in developing countries. According to the report, the way countries design their intellectual property system is key in the development of local innovation and production. However, health outcomes will depend on the accessibility and affordability of good-quality essential medicines.
The report released yesterday (March 24) seeks to map strategies and options available to developing countries to facilitate local production. In particular, the report describes options for the design of countries’ intellectual property system so that it supports local manufacture of generic medicines.
According to the report, “the existence of a patent does not mean local production is not possible.” Multiple ways allow local production through cooperation and the use of flexibilities in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Licensing and cooperation by patent holders have been increasing, it said.
Intellectual property “plays an important role both for the researching pharmaceutical industry, which relies heavily on intellectual property to protect its products, and for generic companies, which produce copies of existing medicines once patent protection expires,” the report states.
Trademarks. trade secrets, and protection of clinical test data are also used as means of IP protection, it noted.
Several examples of strategies and options to encourage local production are presented in the report, which also provides “patent information on a number of medicines to show that it is a simplification to describe a medicine as ‘under patent’.”
The IP environment is only one of the conditions which impact the local production of medicines, the report said, and in itself will not be decisive.
“The mere absence of a patent in a country will not lead to local production of a medicine or ensure access to that medicine.” However, the IP system can be designed to favour local production and innovation, it said.
The report also notes that local production does not necessarily lead to improved access and health outcomes, which is conditioned by the availability of good-quality essential medicines and their affordability.
The IP system in a country depends on which World Intellectual Property Organization treaties the country adheres to, whether that country is a member of the WTO, and which trade-agreement obligations it is under, according to the report.
The report focuses on WTO members that have a local generic industry with some capacity for innovation. In particular, its aim is to provide guidance to policymakers on designing an IP system conducive to local production and public health, “to show how and where local production can take place despite existing intellectual property regimes,” and that even if a medicine is patented in some countries, “the complete landscape of the patents could reveal that local production of the same medicine is possible in countries where the patents were not filed or granted.”
Use of TRIPS Flexibilities
Flexibilities available under the TRIPS Agreement can be separated into pre-grant and post-grant flexibilities, said the report. Pre-grant flexibilities concern the granting process, and can prevent the issuing of patents. Post-grant flexibilities include oppositions or revocation mechanisms.
Some countries, such as India, have introduced more stringent patentability standards and have influenced other countries with local production capacity – such as Argentina, Brazil, the Philippines, and South Africa – to revise their patentability requirements with respect to pharmaceuticals.
Other options can be used, the report said, as in Brazil and Egypt, where the ministries of health play an active role in the patent examination process for pharmaceutical patents. Some developed countries also have applied stricter interpretation of patentability criteria, such as Switzerland, which in 2007 revised its patent law to introduce stricter standards towards the patentability of genes, according to the report.
The report also underlined the importance of access to patent information and how this can support the use of certain pre-grant flexibilities to “increase the space for local generic companies and facilitate local production.”
The decisive question when a medicine is patented is how the patent will be managed by the patent holder, said the report, which said “collaboration has increased over the past years, sometimes blurring the line of distinction between originator and generic companies.”
The report is the second phase of a project undertaken by the WHO and supported by the European Commission on improving access to medical products in developing countries, through the building of capacity for local production and related technology transfer. The first phase of the project reviewed trends and barriers to local production of pharmaceuticals, vaccines and diagnostics.