On the Legal Protection Mechanism for Research and Development Incentive of Orphan Drugs and Medical Devices
Orphan drugs and medical devices are related to people's lives and health.How to incentivize enterprises to increase R&D in-vestment and ensure the safety,effectiveness,and accessibility of the products is an important issue faced in comprehensively promo-ting the construction of a healthy China.China has accumulated beneficial experience in implementing R&D incentive through legisla-tion,but there are problems such as single incentive measures,lack of key systems,imbalance in incentive fields,lack of specialized legislation,policies need to be legalized,conflicts between norms.From the perspectives of protecting the rights and interests of pa-tients,implementing constitutional provisions,and strengthening institutional construction,we should improve the availability of the products through institutional innovation and synergy on the track of the rule of law.In terms of the construction of the legal protection mechanism for R&D incentive of orphan drugs and medical devices,the ideas of equal emphasis on responsive and forward-looking leg-islation,equal emphasis on R&D incentive and full lifecycle supervision and so on should be adhered to.The R&D incentive legislation should be integrated into general laws and special laws,and the lower-level laws should be enacted around regulatory processes.The fo-cus of institutional construction which framed the substantive content of legislation should be clarified based on the goal of saving R&D costs before registration,accelerating the process during registration,and improving R&D returns after registration.
Rare diseaseOrphan drug and medical deviceR&D incentiveLegal protection mechanism
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