Public health; TRIPS Agreement for Patent Protection; Legal interests take precedence; Balance of interests; Compulsory license; Parallel import; Differential pricing.
First, the global public health crisis.
According to reports, in 2002,150,000 people died of infectious diseases in the world, and tens of millions of people were on the verge of death after being infected with AIDS. [1] In Africa and Latin America, deadly infectious diseases such as malaria, tuberculosis and AIDS are spreading horribly, becoming catastrophic killers attacking the health and economic development of local people. There are many reasons for the public health crisis in these areas, and one of the key factors is that local people can't get effective and cheap treatment drugs. Millions of people die of infectious diseases every year. In most cases, these diseases can be prevented and treated. Especially in developing countries, the mortality rate of these infectious diseases is particularly high. Many people die from the high price barrier formed by drug patents, which prevents them from obtaining effective and cheap treatment drugs. Global public health crisis and intellectual property protection have therefore become hot issues in the world today. [2]
The global public health crisis is imminent.
Second, the WTO coordination document on patent protection and public health issues and its comments.
(1) Overview
In order to solve the growing public health crisis in developing countries, the Fourth Ministerial Conference of WTO held in Doha in 2006 issued the Doha Declaration on TRIPS and Public Health. According to the above declaration, the WTO began negotiations on public health issues, and it is planned to start in 2002. On August 30th, 2003, after 20 months of arduous negotiations, the General Council of WTO finally broke the deadlock, and the governments of all member countries unanimously adopted the Final Document on Implementing the Compulsory Licensing System for Patented Drugs, so that poorer countries with insufficient or no production capacity in the pharmaceutical field can more easily import cheaper unregistered drugs produced under the compulsory licensing system (internationally, the production without patent authorization is called "unregistered production"), and the price of their products is much lower than that produced under patent protection.
The Doha Declaration on Trade-related Intellectual Property Rights and Public Health confirmed the right of WTO members to use compulsory licensing and parallel import measures, and politically and legally enhanced the ability of developing countries to obtain medicines. With the support of the Declaration, it is necessary for developing countries to make full use of the flexibility of TRIPS Agreement to promote public health, including (1) the right of contracting parties to implement "compulsory license" and the right to decide the reasons for implementing "compulsory license"; (2) The contracting parties have the right to determine what constitutes a "state of emergency or other extreme emergencies", and the public health crisis caused by infectious diseases such as AIDS and malaria constitutes this "state of emergency"; (3) Each contracting party has the right to construct its own "exhaustion principle" system under the premise of observing the most-favored-nation treatment and national treatment clauses; (4) Developed countries should promote and encourage their enterprises to transfer technology to the least developed countries. The time for the least developed countries to provide pharmaceutical patent protection can be postponed to 20 16. The birth of Doha Declaration is an important event in the field of international intellectual property. [3]
(2) Declaration on the Agreement on Intellectual Property Rights and Public Health and its analysis.
With the efforts of developing countries, public health and intellectual property rights have become the topics of Doha Conference. At the Fourth Ministerial Conference of the World Trade Organization held in Doha, Qatar, in 20001,165438 10, with the efforts of the third world countries, the participants negotiated the TRIPS Agreement and public health for three days and adopted the Declaration on Intellectual Property Rights Agreement and Public Health. At the Doha Conference, developing countries represented by South Africa called for respecting people's right to life and health and safeguarding public interests, which was well received by developed countries in the field of intellectual property rights. The Doha Declaration recognizes the seriousness of public health problems that plague many developing countries and least developed countries. Emphasize the importance of intellectual property protection to the development of new drugs, and also acknowledge the state caused by the impact of this protection on prices; Agree that TRIPS should not be an obstacle for Parties to take actions to protect public health. Clarified the following issues related to TRIPS Agreement and public health:
1. It is recognized that it is an inalienable right for the state to take measures to protect public health. Article 4 of the Declaration states: "We agree that the TRIPS Agreement cannot and should not prevent members from taking measures to protect public health. Therefore, while reaffirming our commitment to the Agreement on Trade-related Aspects of Intellectual Property Rights, we confirm that the Agreement can and should support the right of WTO members to safeguard public health in interpretation and implementation, especially the right to obtain medicines. Therefore, we reiterate that WTO members have the right to make full use of the provisions in the Agreement on Trade-related Aspects of Intellectual Property Rights that provide flexibility for this purpose. "According to this article, if the intellectual property rules hinder the above-mentioned rights of the state, such as maintaining the high price of patented drugs, the state may take measures in line with the provisions of the TRIPS Agreement to suspend the exercise of exclusive rights by the right holder.
2. Clarify the flexible clauses in TRIPS Agreement that can be used to protect public health and resist intellectual property rights. Including: (1) The TRIPS Agreement should be interpreted according to the aims and purposes expressed in its objectives and principles; (2) Members have the right to issue compulsory licenses and freely decide the reasons for issuing compulsory licenses. Members have the right to issue compulsory licenses without the consent of the obligee, and have the right to freely decide the reasons for issuing compulsory licenses, including national emergency or other extreme emergencies that cause public health crisis, including AIDS, tuberculosis, malaria and other infectious diseases, so as to implement compulsory licensing measures as soon as possible; (3) The parallel import rights of members are clarified, and the effect of the provisions on the exhaustion principle of intellectual property rights in the TRIPS Agreement is stipulated, allowing members to freely establish their own exhaustion principle system, as long as it does not violate the most-favored-nation treatment principle and the national treatment principle stipulated in the TRIPS Agreement.
3. Recognizing the current situation that the least developed countries are unable to make effective use of compulsory licensing measures due to insufficient or no production capacity of pharmaceutical industry, instruct the Council of TRIPS to explore ways to solve this problem and report to the General Council before the end of 2002.
4. Extend the transitional period for LDCs to fulfill their drug obligations under the Agreement on Trade-related Aspects of Intellectual Property Rights to 20 16. Relevant obligations refer to the obligations stipulated in Section 5 (patents) and Section 7 (protection of undisclosed information) of Part II of the TRIPS Agreement. This provision provides an opportunity for the least developed countries to reconsider their drug-related intellectual property laws and import and produce generic drugs, but its limitations are also obvious, that is, the least developed countries still have the obligation to protect the patents of medical methods, and the transitional period for the least developed countries to fulfill their TRIPS obligations in other aspects except medical products still ends at 1 in 2006.
5. Reaffirm the commitment of developed country members to encourage their enterprises and institutions to promote and encourage technology transfer to the least developed countries in accordance with Article 66, paragraph 2, of the TRIPS Agreement.
The significance of this declaration is positive. It confirms that public health should take precedence over private property rights, and clarifies the right of WTO members to make full use of the flexible clauses in the TRIPS Agreement. However, apart from clarifying the existing relevant provisions of the TRIPS Agreement, extending the transitional period for the least developed countries to implement the TRIPS Agreement, allowing the government to freely decide public health emergencies and issue enforcement permits, the Declaration has not resolved the fundamental conflict between the TRIPS Agreement and the protection of public health.
(three) the final document and analysis of the compulsory licensing system for patented drugs.
On August 30, 2003, after 1 year and eight months of arduous negotiations, the General Council of the World Trade Organization finally unanimously adopted the Final Document on Implementing the Compulsory Licensing System for Patented Drugs to Solve the Public Health Problem, which marked that all members of the World Trade Organization finally reached a final understanding on solving the public health problem. According to the Ministerial Declaration and Statement on the Agreement on Intellectual Property and Public Health issued by the Doha Ministerial Conference of the World Trade Organization (200 1+ 1), WTO members should implement the licensing system for patented drugs before June 5438+February 3, 2002. In order to solve the public health crisis of developing and least developed members, the mandate of the Doha Ministerial Conference of WTO has finally been completed, and the negotiation process that has been deadlocked for eight months has finally come to an end and entered the stage of concrete implementation of the relevant final documents. According to the final document adopted by the WTO General Council, when developing members and least developed members have public health crisis in China due to epidemic diseases such as AIDS, malaria and tuberculosis, they can refer to the final document and implement the compulsory patent licensing system in their own countries for public health purposes without obtaining the permission of the patentee. In order to produce, use and sell patented drugs for treating diseases that cause public health crisis, this will not only greatly reduce the market price of related patented drugs, but also help to control and alleviate public health crisis more quickly and effectively, and ensure that the basic rights of life and health are respected and protected. As a developing member of the World Trade Organization and a country affected by public health problems, China actively participated in the negotiations on this issue from the very beginning, submitted proposals and suggestions for solutions, and worked with other developing members to actively seek a final solution acceptable to all parties. The final document adopted by the WTO General Council will help China to implement the patent drug licensing system, further improve its ability to control the epidemic of diseases and solve domestic public health problems, and ensure people's life, health and safety.
However, as pointed out by some analysts, the decision is not clear about the scope of infectious diseases, the flexibility to explain the public health crisis and how to provide cheap drugs to the least developed countries, which has laid a controversial hidden danger for the actual operation of the decision. In addition, there are too many rules and regulations attached to the decision, which makes it impossible for low-income countries to really get enough cheap drug supplies. All these reflect that the contradiction between drug patents and the acquisition of necessities has not been finally resolved. [4]
After the General Council of the World Trade Organization adopted an agreement on the implementation of the compulsory licensing system for patented drugs on August 30, the parties concerned reacted differently to this agreement, which is conducive to making it easier for poor countries to import cheap generic drugs to treat AIDS and other major infectious diseases when necessary.
When talking about the significance of the agreement, Supachai Panitchpakdi, former Director-General of the World Trade Organization, pointed out that it is a historic agreement, which will enable poor countries to give full play to their flexibility in dealing with major epidemics raging in their own countries within the scope of WTO intellectual property rules. The representative of Kenya to the WTO said that the agreement is good news for Africa, especially for those who are in urgent need of medical treatment.
However, some people in the health sector believe that the agreement has set many restrictions and red tape, and the result will be that in countries where AIDS and malaria are rampant, the price of drugs will not fall to the level that patients can bear. Some international humanitarian organizations also pointed out that this agreement aimed at enabling poor countries to obtain cheap drugs did not provide a feasible solution. According to this agreement, when developing members and least developed members of the WTO have a public health crisis due to epidemic diseases such as AIDS, malaria and tuberculosis, they can produce, use and sell patented drugs for treating diseases that lead to public health crisis without the permission of the patentee. [5]
We should be soberly aware that the contradiction between drug patent protection and public health is irreconcilable, because it is a confrontation between the national life of developing countries and the profits of drug dealers in developed countries. Therefore, it is only a mirage to achieve the balance between the two through the Doha Declaration, which can only be regarded as the wish of the weak and the decoration of the strong. Of course, we should also see that the significance of the Doha Declaration is positive, because it confirms that public health rights take precedence over private property rights, and clarifies the right of WTO members to make full use of the flexible clauses in the TRIPS Agreement, which is worthy of recognition. Since China has promised to fully implement the WTO Agreement on Trade-related Aspects of Intellectual Property Rights, including the provisions on drug administration, when it joined the WTO, the relevant progress of the Doha Round is also of great significance to China. We should make full use of this clause in favor of developing countries and strive to reach a more reasonable coordination plan on the conflict between public health and intellectual property rights within the framework of Doha Declaration.
Third, the coordination between drug patent protection and public health
(A) the significance of coordination
The granting and protection of patent right is a reward to the creator, and it is the natural connotation and inevitable result of promoting scientific and technological progress in the era of knowledge economy. Patent right is a private right, and health right is a basic human right closely related to people's right to life and survival. Both the patent right and the right to health have their legitimate reasons and are generally recognized by the international community. "However, this does not mean that jurisprudence must regard all interests as necessarily at the same level, nor does it mean that any qualitative evaluation is infeasible. For example, the interest in life is a legal prerequisite for protecting other interests (especially all personal interests), so it should be declared higher than the interest in property. " [6] How to solve the contradiction and conflict between the patent right as the main protection of property rights and the right to health as the protector of human health and life?
From the analysis of the basic categories of patent right and health right, we can draw a general conclusion to deal with the relationship between patent right and basic human rights.
1. Regarding the conflict of rights, the principle of "giving priority to the protection of legal interests" should be followed.
Such as freedom of speech, privacy, health and environmental rights, are all basic human rights recognized by international conventions. These rights are either indispensable freedoms for human beings to exist as subjects or necessary conditions for human survival and development. Compared with the property right of intellectual property, the above-mentioned human rights should have a superior position, that is, they should be regarded as the value of priority law. Implementing the principle of "giving priority to protecting interests" means that the modern intellectual property system should not only conform to the provisions of international intellectual property conventions, but also not conflict with international human rights standards. Lawmakers should abide by their international human rights obligations when providing legal protection for intellectual property rights. According to this idea, the author thinks that the right to health should be protected before the patent right. Intellectual property rights, including patent rights, should not only be the defenders of property rights, but also the patron saint of social welfare. The reasons are as follows: First, the right to health takes precedence over the patent right itself. The legal essence of intellectual property rights is private rights. Compared with the property right of patent right, the right to health is more directly related to people's life and their survival and development. As a basic human right, the right to health should naturally have a superior position compared with the patent right as a private right, mainly a property right.
Secondly, the conflict between patent rights and the right of AIDS carriers and AIDS patients to receive treatment, in the modern context, especially when AIDS has become a serious public health problem in developing countries, is no longer simply a conflict of rights itself, but also a conflict between private interests and public interests. This reflects a question, that is, whether the legal system of intellectual property rights needs a moral bottom line and whether the protection of intellectual property rights should be bound by human rights standards. The author believes that based on the priority of human rights, internationally recognized basic human rights are the moral bottom line of intellectual property legal system. This also means that the construction of the intellectual property legal system for the protection of property rights in patent rights should be carried out under the framework of basic human rights, and it should not be divorced from basic human rights and simply or excessively pursue self-interest. The trade dispute between multinational corporations and South Africa also fully shows that intellectual property rights have a moral bottom line and should meet modern human rights standards. The case of South Africa is the victory of human rights over patent rights. "A good legal system must meet the requirements of justice and morality."