Resolution And Conflict Between Access To Pharmaceuticals And Patent Protection In International Public Health Events

"The history of mankind is the history of its diseases." From AIDS and malaria to outbreaks of COVID-19 pandemic,international public health events of high risk,transnational and urgency have plagued the whole world,especially developing and least developed countries,posing a threat to the right to health.Pharmaceuticals are the guarantee to fight disease and maintain healthy,the right to access to affordable pharmaceuticals is a part of human rights.Compared to other products,pharmaceutical research and development is characterized by high investment,low success rates and long lead time,therefore highly dependent on the innovative incentive function of patent,which bring benefits that promote the development of the industry and the generation and upgrading of pharmaceuticals.However,monopoly and exclusivity protection also hinder the production of generic medicines,raise the price of pharmaceuticals,impose heavy economic burden on the countries,thus hinder the realization of social welfare.How to solve the conflict between pharmaceuticals accessibility and patent protection is a problem that cannot be avoided for the development of patent system.The TRIPS Agreement includes pharmaceuticals in the scope of patent protection,in order to alleviate the impact on public health,the Agreement also includes compulsory licensing and develops a "Paragraph 6 System" by amendments.In national practice,developed countries tend to restrain the implementation of compulsory licensing,while developing countries tend to make full use of the system,but such tendency is not absolute,in a global crisis such as COVID-19 pandemic,countries have made use of compulsory licensing according to the actual situation,whether reviewing past practice or looking ahead to future need,compulsory licensing system has certain necessity.Unfortunately,due to various deficiencies of the system,developing countries are unable to fully utilize compulsory licensing to alleviate their pharmaceuticals accessibility problems,thus need to improve the system.It is for this reason that South Africa and India have submitted proposals for waiver specific obligations under the TRIPS Agreement in 2020,but this mechanism which negates the value of patent protection,is not conducive to development and innovation in the long run,but rather leaves developing countries in the dilemma of having no available pharmaceuticals.Nonetheless,the positive actions of developing countries have led to the adoption of the Ministerial Decision at the WTO Ministerial Conference,which provides greater flexibility for developing countries in applying the compulsory licensing and opens a breakthrough for further improvement of compulsory licensing.Beyond the compulsory licensing system,the long-term plight of developing countries and the lessons of the COVID-19 pandemic made the international community realize that voluntary sharing of technologies and products is more conducive to the realization of common interests than monopoly,mechanism such as the Global Distribution Mechanism for Medicines and the Medicines Patent Pool thus emerged.Although these systems still have the problems including insufficient incentives,lack of legally binding force,and difficulties in promoting multilateral coordination,the mechanism can reduce the restrictions on patent rights,realize the participation of multiple parties in health governance,is in line with the concept of “a Community with a Shared Future for Mankind”,and more conducive to helping developing countries improve their own technology through technology transfer at the same time.Therefore,in order to resolve the conflict between access to pharmaceuticals and patent protection,it is necessary to incorporate some provisions of the Ministerial Decision on remuneration standards and export of pharmaceuticals into the existing compulsory licensing system,while amending Article 31 of the TRIPS Agreement to simplify the procedures of pre-consultation and independent review.Developing countries should learn from the lessons from the Doha Declaration and IP waiver negotiations,promote the improvement of the compulsory licensing system by means of transparent negotiation and giving full play to the role of NGOs.In addition,the international community should complement the "pre-negotiated" function of the sharing mechanism,provide multiple incentives,and promote the negotiation of the pandemic convention to strengthen the binding force,so as to build an effective pharmaceutical patent sharing mechanism.The structure of compulsory licensing as basis of the sharing mechanism can not only exert the function of legal leverage of compulsory licensing system,but also avoid the possible adverse effects the implementing countries may face,so as to resolve the conflict between pharmaceuticals accessibility and patent protection.