context: In line with Beijing’s long-term of goal of transforming China into a pharmaceutical powerhouse on the world stage, proposals to accelerate the development and rollout of innovative medical drugs and devices continue to be put forth.
At the recent second meeting of the 14th CPPCC (Chinese People’s Political Consultative Conference) Shanghai Committee, the democratic national construction sector of the committee proposed the establishment of a ‘National biomedical industry innovation Shanghai pilot zone’, in response to practical problems including high entry barriers and low commercial conversion rates in China's innovative drug research and development realm.
In order to optimise the process of innovative drug device evaluation and approval, the meeting suggested that Shanghai should be the main testing site to help China's biopharmaceutical industry break through internationalisation-related bottlenecks.
Compared with the development of major international biopharmaceutical industry zones, Shanghai's biopharmaceutical industry needs to continue to improve its international competitiveness in order to better integrate into and gradually reshape the international biopharmaceutical industry pattern.
Since innovative drug R&D is a major area of competition among major pharmaceutical companies, efficiency and international recognition are both of great significance to the international competitiveness of innovative drugs. The proposal put forth by the democratic national construction sector of the committee pinpoints two major problems for innovative drug and device approval work
- the overall time required for new drug approval is too long
- a lack of drug application approval authorities
To better tackle these and other problems, the democratic national construction sector of the committee suggest
- exploring the possibility of setting up a ‘National biomedical industry innovation Shanghai pilot zone’
- establishing the concepts of ‘encouraging innovation, focusing on efficiency and addressing clinical needs’ for the clinical evaluation process of innovative biopharmaceutical devices
- making the biopharmaceutical listing evaluation process internationally competitive
- strengthening functions such as clinical trial application approval, clinical trial review and marketing approval to make the evaluation and marketing system for innovative pharmaceutical products more flexible
- introducing more reviewers and external experts, expanding the certification bodies and expert resources for third-party clinical reviews as well as improving the objective and lenient accountability mechanism for reviewers
- promoting the establishment of green approval procedures for biopharmaceutical enterprises, reducing approval processes and improving approval efficiency
- strengthen the exchange of review technology and mutual recognition of review results with international mainstream review agencies
In addition to suggestions for the review and approval process system, since domestic innovative drugs are also affected by payment methods, pain points including low commercial conversion rates were also discussed. Recommendations include
- in terms of medical insurance negotiations
- provide reasonable profits for innovative drugs to support their continuous growth
- establish a co-payment mechanism between commercial health insurance and medical insurance
- incorporate Shanghai Huibao into the innovative drug and device products produced by local enterprises in Shanghai
- in terms of the admission of innovative drugs
- establish fast admission and application channels
- build a nationally unified green network and admission channel
- strengthen the construction of a national unified payment system for innovative drugs and devices, as well as a floating payment pricing system that is centrally coordinated and combined with commercial insurance and medical insurance in various regions
With regard to advancements in the international market, the proposal suggests
- establish a joint working mechanism for Shanghai's innovative drugs to go global
- provide a good policy environment and service support system for enterprises
- encourage biopharmaceutical companies to actively participate in international cooperation programs such as the World Health Organisation
- offer subsidies for innovative drugs that have obtained clinical research approval abroad