It is important to note that the EU proposals on IP are TRIPS-plus in multiple regards and would surely reduce policy space in Indonesia and negatively impact access to affordable medicines. Even a preliminary review of the proposal reveals:
- A requirement to make all reasonable efforts to abide with the WIPO Patent Law Treaty, which risks enshrining lower standards of patentability.
- Mandatory patent term extensions to compensate for regulatory delay in granting marketing approval of medicines with a proposed minimum 15 year term of effective patent coverage.
- An additional mandatory patent term extension in the case of pediatric studies.
- Enhanced enforcement measures in terms of: intermediary liability, mandatory provisional measures, border measures involving suspected patent violations, and lost-profit damages.
- National and regional exhaustion of rights only, limiting right of parallel importation.
Although lip service is paid to preserving TRIPS-flexibilities and self-congratulations about preserving compulsory licensing rights enshrined in the Doha Declaration, the EU proposals are profoundly TRIPS-plus. The impacts of patent term extensions and data/marketing exclusivities based on registration-related data/decisions on access to more affordable generic medicines will be profound. The number of years of TRIPS-plus protections has not yet been finally determined, but the pretense of protecting access-to-medicines must be condemned.
Brief Analysis by Professor Brook K. Baker, Health GAP (Global Access Project) & Northeastern U. School of Law, Program on Human Rights and the Global Economy Honorary Research Fellow, Faculty of Law, Univ. of KwaZulu Natal