The flexibilities afforded by TRIPS can only be utilized if they are incorporated into a country's domestic legislation. This is a first and necessary step in any attempt to use the flexibilities for public health purposes. It is therefore important that countries enact legislations that allow them full flexibility. However, many developing countries have not incorporated the TRIPS flexibilities into their laws for various reasons. What the TRIPS Agreement permits and what countries actually do are two different things. In the end, it is national law and practice that will be decisive, both in terms of providing access to medicines, and in establishing a domestic framework in which TRIPS rules will be interpreted. One major reason many developing countries have not incorporated TRIPS flexibilities into their national laws is lack of technical expertise.
Virtually all national patent systems of developing countries are modelled on European and United States patent laws. These are often based either upon colonial statutes or on laws crafted with the help of technical assistance from WIPO and the patent offices of developed countries.38 Most of the technical assistance that has gone to these countries, however, is more concerned with compliance with the provisions relating to the rights of the patent holders rather than the application of flexibilities within the multilateral framework to promote and protect public health.39
38 Love (2001).
39 Balasubramaniam (2002).
Another problem that exacerbates the lack of technical expertise to implement TRIPS flexibilities in national laws is the inability to access information on best practices. Developing countries are generally not aware of the measures undertaken by their counterparts around the world. As a result, even countries within a region with similar or the same access problems adopt different strategies, with varying degrees of success. More importantly, while most developed countries are quick to provide assistance and to give examples of best practices on how to protect patent rights, there is never a best practice guide or technical assistance, for example, on the extensive use by the United States of compulsory licensing or antitrust legislation to curb abuse of patent rights and serve other public interest purposes.40
40 For further discussion on the use of compulsory licensing in the United States see Reichman and Hasenzahl (2003).
The lack of expertise has also increased the likelihood that frivolous patents or even patents on excluded subject matter will be issued. Under the TRIPS Agreement, states may, for example, exclude from patentability diagnostic, therapeutic and surgical methods for the treatment of humans or animals as well as plants and animals other than micro-organisms and new uses of known products. These exceptions are rendered nugatory in the absence of expertise. In the Philippines, for example, patent examiners routinely rely on the issuance of United States or European patents as a precondition to the grant of a Philippine patent, notwithstanding the fact that Philippine patent law excludes certain subject matter that may be allowed under the United States and European patent laws such as business methods and computer programmes.