656. We understand that intellectual property and the public interest are central components of the TRIPS Agreement, and how to strike a balance between intellectual property protection and the public interest are important public policy objectives for Members. There are relevant provisions in our Patent Act as follows:
657. In order to implement the spirit declared by the Doha Declaration on the TRIPS Agreement and Public Health and the WTO General Council resolution, and for purposes of assisting Members with insufficient or no manufacturing capacity in the pharmaceutical sector to obtain pharmaceutical product(s) needed for treating HIV/AIDS, tuberculosis, malaria and other epidemics, according to Articles 90 and 91 of our Patent Act, when complying with certain requirements and agreeing to comply with the relevant regulations prohibiting the re-export of compulsory licensed pharmaceuticals, the Specific Patent Agency may, upon request, grant a compulsory license to the requestor to exploit a patent concerned for the purpose of producing and importing pharmaceutical product(s) to these Members.
658. Besides, according to Article 60 of our Patent Act, the effects of the patent right shall not extend to research and trials, including their practical requirements, necessary for obtaining registration and market approval of drugs under the Pharmaceutical Affairs Act or obtaining market approval of pharmaceuticals from a foreign country. It will help the pharmaceutical companies to obtain marketing approvals, so that the general public can choose and obtain more reasonable pharmaceutical product(s) as soon as possible.
659. Regarding drug prices, our National Health Insurance adopts a value-based pricing mechanism in new drug pricing when a new drug has to obtain market approval before listing. To ensure rational allocation of medical resources, a new drug has to undergo pricing review procedures prior to listing, in which the economic and therapeutic values of the new drug are evaluated, and the listing prices are decided based on the evaluation results.
660. Regarding drugs covered by our National Health Insurance, to ensure reasonable listing prices, price and volume surveys are implemented, so that price adjustments can be done by referring to the actual transaction prices and to reflect the real situation on the market. Besides, patents are taken into consideration in the price adjustments, in which listed drugs are classified into various categories based on their patent status and different price adjustment formulas are applied to different categories.
661. Our National Health Insurance adopts a value-based pricing mechanism in new drug pricing. In terms of pricing methods, a new drug is priced based on international prices of the new drug, or the listing prices or the international prices of the comparators, and may enjoy mark-ups in certain cases such as drugs with better clinical benefits. Certain drugs such as those used for rare diseases can not only be priced based on the international prices of related products, but can also be priced by cost-calculation methods.
662. The decision on new drug pricing review is made by a joint meeting composed of stakeholders including authority officials, scholars and experts, beneficiaries, employers, healthcare providers, etc. Moreover, the meeting minutes and meeting sound records are disclosed on the website.
663. Regarding the improvement of the transparency of the patent landscape of medical technologies, our Pharmaceuticals Affairs Act was amended on January 31 last year (2018) to introduce the system of patent linkage of drugs, entered into force on August 20 this year. According to the main points of the amendments, the holder of a new drug permit should submit the patent information regarding such drug within 45 days after the receipt of the drug permit. The holder of a new drug permit should also list and make public the patent information of the new drug in the Registration System for Patent Linkage of Drugs.
664. Through patent linkage, we ask the holders of new drug permits to disclose patent information of the drugs soon after market launch. By making such information public, we encourage generic drug companies to learn the patent status of the new drugs first, and carry out necessary circumvention as they develop their own drugs. This shall help to reduce risks of suspension of sales caused by infringement disputes after the drugs are put on the market and also provide more comprehensive IP protection for drugs.
