China will promote the research and availability of generic drugs, and improve their quality and efficacy to lower healthcare costs and to better meet public demand, according to a document released by the State Council on April 3.
Drugs that are indispensable for clinical treatment and in short supply will be encouraged to be made generic, especially those for the treatment of major infectious diseases, rare diseases, pediatrics and public healthcare incidents.
The lists of encouraged generic drugs will be published regularly by the medical authority. Research projects on key drugs will be enrolled in national technology programs.
Protection of the intellectual property rights of generic drugs will be enhanced to balance the interests of patentees and the public. Antitrust legislation also will be stressed to prevent the abuse intellectual property rights.
Quality and efficacy consistency evaluation of the generic drugs will be promoted. Hospitals, colleges, academic institutions and private evaluation institutions all will be encouraged to take part.
Quality standards of drug materials and packing materials will be modified to promote new materials and new techniques, so that dependency on imports for some materials will be ended.
Reform of the evaluation and approval systems for drugs should be deepened. Permits for generic drugs will be strict, based on the consistency of quality and efficacy between generic and original drugs.
A quality management and tracing system will be set up, covering the whole life-span of generic drugs, including research, production, circulation and use.
Generic drugs will be placed in the official procurement lists and in the interchangeable lists with original drugs. When treating AIDS and tuberculosis patients, generic drugs will be given priority.
Tax and price preferences will be offered, as well as incentives regarding basic healthcare insurance.