| Since the outbreak of global COVID-19 pandemic in 2020,global public health has faced an extremely serious challenge.As of March 2023,more than 700 million cases of COVID-19 had been confirmed worldwide,including nearly 7 million deaths.In this unprecedented public health crisis,the contradiction between intellectual property exclusivity and the need to protect life and health is increasingly prominent.As an effective tool for epidemic prevention and control,COVID-19 vaccine has been widely recognized as "global public goods".The international community has made some efforts to remove the obstacles caused by intellectual property exclusivity to the realization of the goal of equal access to global vaccines.The MC 12 adopted a decision on the COVID-19 vaccine patent waiver.However,can the goal of vaccine accessibility be achieved by only emphasizing the patent waiver? While the importance of patent in vaccine production is self-evident,the importance of trade secrets should not be ignored.Under the circumstances that the current system obviously lacks the provisions on the involuntary licensing of vaccine trade secrets,we should break the shackles of traditional thinking and consider the feasibility of constructing the compulsory licensing system of vaccine trade secrets from the perspective of realizing the accessibility of vaccines.The conception of this system cannot be separated from four aspects: necessity,justification,legitimacy and specific legal system arrangement.On the issue of "whether it is necessary to construct compulsory licensing system of vaccine trade secrets",this paper considers the special significance of trade secrets in vaccine production and the effective assistance offered by compulsory licensing of vaccine trade secrets to achieve vaccine accessibility.Trade secrets are the key IP in vaccine production and are the core factor in deconstructing the production process.In order to protect the monopoly position in the vaccine market,pharmaceutical companies generally choose the mode of "patent + trade secret" protection,which makes vaccine production strictly controlled in the hands of a few pharmaceutical companies,thus affecting the vaccine supply.The implementation of compulsory licensing of vaccine trade secrets is not only a reinforcement of the current channels to achieve vaccine accessibility,but also an important means to attract new vaccine producers,especially those with production capacity in low-and middle-income countries,to expand vaccine production and promote vaccine supply.Meanwhile,the natural deterrent of compulsory licensing makes it an important tool of support for lowand middle-income countries in vaccine price negotiations.On the issue of "whether it is legal to construct compulsory licensing system of vaccine trade secrets",this paper firstly points out that the compulsory licensing system of vaccine trade secrets is no different from the traditional compulsory licensing system of intellectual property rights in basic nature.For example,both of them are tools to balance public and private interests,and both of them are non-voluntary,non-exclusive and non-transferable,and break the territorial principle.Meanwhile,the compulsory licensing system of vaccine trade secrets also has its new features,such as stricter licensing requirements and supervision requirements,and strengthened responsibility requirements.This paper then explains that ensuring vaccine accessibility takes precedence over protecting vaccine trade secrets and that compulsory licensing of vaccine trade secrets will not detract from drug innovation incentives,justifying the establishment of this system from the legal-rational perspective.This paper also analyzes the issue from the bases of the international law,the domestic legislation and judicial practice of extraterritorial countries.This paper illustrates from the perspective of international law that the establishment of compulsory licensing system of vaccine trade secrets does not violate the provisions of international treaties and conforms to the purpose of treaties by interpreting TRIPS Agreement,Doha Declaration and International Covenant on Economic,Social and Cultural Rights.In addition,relevant reports of the United Nations are quoted to point out the legitimacy of the system from the perspective of safeguarding public health requirements.From the perspective of extraterritorial legislations and judicial practices,this paper mainly takes legal provisions and judicial precedents similar to the compulsory licensing of trade secrets in the United States,the United Kingdom,the European Union and Brazil as examples.Through the interpretation,analysis and examples of international treaties and legal documents as well as domestic legislations and judicial practices,the legitimacy of the construction of compulsory licensing system of vaccine trade secrets is explained.After analyzing the necessity and legitimacy of the construction of compulsory licensing system of vaccine trade secrets,this paper puts forward the specific arrangement of the system.Considering the balance of public and private interests,which is the core of the system construction,the arrangement of the system is mainly considered from four aspects that are most likely to lead to the imbalance of interests.Firstly,it is proposed to limit the license prerequisite of this system to the occurrence of "public health crisis".Secondly,it is proposed to establish an independent third-party supervision mechanism to determine the scope of license.Thirdly,it is proposed to clarify the criteria of reasonable royalty,and finally it is proposed to strengthen the warranty obligation of the government and the confidentiality obligation through the whole process of compulsory licensing.Combined with the above issues,this paper finally put forward countermeasures and suggestions on the establishment of compulsory licensing system of vaccine trade secrets from the aspects of legislation and practice.At the legislative level,it is suggested that the compulsory licensing of vaccine trade secrets should be explicitly allowed in domestic legislations,and the specific system design is arranged.In practice,the system emphasizes the supervision of compulsory licensing of vaccine trade secrets,which mainly includes strengthening the government’s fulfillment of guaranteed obligations,setting up an independent third-party supervision mechanism and implementing confidentiality responsibility. |
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