Intellectual Property Protection and Access to Medicines Daw Phyu Phyu Thinn

Contents Introduction Right to IP Protection Right to Affordable Medicines Key provisions of TRIPS Role of Doha Declaration Compulsory Licensing Parallel Importing Conclusion

Introduction TRIPS provides for Patent protection both product & process for pharmaceutical products. Product patent for absolute production of the product & Process patent in respect of the technology and the method/ process of manufacturer. LDCs unable to access essential medicines as a result of increasing patented drug costs.

Right to IP Protection Patent protection are rooted in the financial commercialization rewards . Incentive for research and development (R&D) and innovations. Without protection, pharmaceutical industries will invest less in research and be less likely to discover drugs for widespread diseases; e.g, Malaria, HIV/ AIDS.

Right to Affordable Medicines Right to Health firmly embedded in numerous international, regional & national declaraions. e.g, Ar. 25 of UDHR, Sec 367 of 2008 Myan Constitution. Access to essential medicines is critical to the fulfillment of the right to health .

Key Provisions of TRIPS TRIPS Agreement introduced global minimum standards for protection and enforcing all forms of IPR, including Patents. Patent protection for 20 years. Prior TRIPS Agreement, protection range from countries to countries; e.g, India (5-7 years)

Cont’d Protection of data submitted for the registration of pharmaceuticals (Data Exclusivity Approach) Before sale or marketing of pharmaceutical product, pharmaceutical companies have to submit data (safety, quality & efficacy of particular drug) to the drug regulatory authority . TRIPS protect ‘undisclosed test data’ against unfair commercial use.

Cont’d Transition Periods TRIPS Agreement provides transition period for LDCs 1. 1995-2000 transition period, 2. 2000- 2005 transition period, & 3. LDCs until 2006, further extended to 2016. Under transition period, pharmaceutical product will not be receive patent production and so generic production is possible/practicable.

Role of Doha Declaration Doha Declaration on TRIPS and Public Health (2001) Striking balance between the right to IP protection and the developing world’s right to health via affordable drugs in the face of extreme disease and poverty. a political statement and ministerial decision that carries legal bearing on WTO members and bodies. a clear platform from which developing countries can raise concerns and structure domestic public health policies.

Compulsory Licensing (CL) TRIPS allows the use of compulsory licenses. CL enables a Government authority to license the use of a patented invention to a third party or Govt. Agency without the consent of the patent owner. CL allows to manufacture and distribute generic drugs. Possible grounds for granting CL National emergencies, Anti-competitive practices by Drugs companies, High prices control.

Cont’d At first time, Patented protected antiretroviral treatment for HIV was cost $ 10,000 per patient per year where over 3 billions people live $ 2 per day. Later, caused by generic production and heavy discount, $ 350 per patient per year. Low-cost generic antiretroviral therapy for patients in developing countries.

Parallel Importing (PI) imports of a patented or trademarked product from a country where it is already marketed. known as comparison-shopping. Principle of PI - the patent holder has been remunerated on the first sale of the drug and further compensation on subsequent sale would exhaust their rights. State - not recognize this - only the patent holder who has been registered has the right to import the protected product.

Cont’d PI often takes place when there is differential pricing of the same product - either brand-name or generic drugs - in different markets. PI can reduce the price of health products and pharmaceuticals by introducing competition.

Conclusion The adoption of intellectual property regimes as required under the TRIPS Agreement can be balanced with efforts to maintain public health treatment programmes while boosting multiple sources of pharma- ceuticals and controlling cost.