According to the official report, Premier Li Qiang presided over an executive meeting of The State Council on July 5 and approved the implementation Plan for Supporting the Development of innovative Drugs in the whole Chain. Although the final formal plan has not been released yet, it is not expected to be much different from the draft circulated in the first quarter of this year. Referring to the last draft, we will discuss the origin of this program and what impact will it have on the future drug access?

 First of all, it is necessary to clarify the definition that innovative drugs in this scheme refer to drugs with independent intellectual property rights and significant clinical efficacy, which are the first approved for market in the world. The definition is very clear, unlike the previous first price draft did not define, some price association seminars to discuss the definition for a long time, the definition is clear until we know whether they are involved. For example, companies with an existing generic layout don't need to pay much attention to this policy, because you can't rely on it. If there are new drugs in the layout, it is necessary to pay close attention to these favorable policies, especially at the implementation level.

Although in the past few years, under the guidance of policies, we have had hundreds of domestic innovative drugs approved, but there are still some problems, such as weak source innovation ability, obvious research and development homogeneity, insufficient policy coordination, no resultant force to promote development; report not urgent public opinion, investment and financing support is weak, etc. From a larger perspective, countries around the world are increasing the development and support of innovative drugs. Some developed countries are curbing and suppressing us, in order to strengthen their dominant position and discourse power in the field of medical science and technology. In the face of pressure and challenges, we continue to strengthen policy coordination and support for the whole chain, build a safer and more efficient medical innovation system, and improve our country's independent research and development and supply of new drugs.

(1) Research and development level

 To speed up the new drug research and development and achievements, optimizing four new (new targets, new mechanism, new structure, new technology) and with independent intellectual property rights, to fill the blank of clinical diagnosis and treatment of innovative drug research and development directory, in science and technology project, research, review and approval, intervention and support, speed up to build a batch of clinical value and market competitive advantage.

Optimize innovative drug review and approval mechanism, resource tendency, give guidance in the R & D PR process; support varieties in the R & D catalogue, shorten the time limit for clinical trial mode from 60 days to 40 days from the date of application acceptance, and shorten the waiting limit for communication meeting to 30 days. At present, it is uncertain whether the formulation of this catalogue will be carried out by the state, or whether the provinces will take the lead and then make comprehensive selection. Does it need enterprises to apply or the relevant leading departments to select directly according to the established rules?

(2) The catalogue of encouraged applications at the level of clinical equipment and application:

 Choose a batch of medical institutions outstanding comprehensive strength, innovative medicine development foundation, health care and business insurance payment ability is stronger, has certain work basis of key areas, comprehensive consideration technology value and clinical value, according to the innovative, safety, effectiveness, economic index factors such as multidimensional evaluation of innovative drugs, develop innovative drugs to encourage application directory. Promote the use of varieties in the application catalogue, and guide drug use institutions to tilt to innovative drugs with high clinical value. Among them, the selection principles of the application catalogue, including significant innovation (approved for the first time in China in recent three years, and new drugs with new targets, mechanisms, structures and technologies and new prescription preparations of traditional Chinese medicine with unique clinical advantages), are preferentially used to solve the unmet clinical needs and have clear clinical value. Key areas, will it be clear to define the scope, or provinces according to their own situation? These questions are very concerned about the enterprise level, but also the actual level of the landing problem, I look forward to an answer in the future.

Improve the assessment mechanism of medical institutions in key areas: the cost of varieties in the catalogue shall not be included in the performance assessment indicators of public medical institutions, such as average drug cost of outpatient service and inpatient drug cost of public medical institutions. Different institutions can set differentiated requirements for equipment and increase the evaluation index of the use of innovative drugs. We will support the separate annual budget of medical insurance varieties and set up separate assessment indicators, and appropriately increase the scale of the use of innovative drugs. Detailed DRG / DIP policies and measures, explore the exemption of varieties in the application catalogue, and determine the implementation period according to the situation.

(3) Access and payment layer

Before acceptance, a declare national traffic, accelerate the net: improve the new innovation medicine centralized accepts the network mode, declare data front audit, enterprises get the drug marketing license application acceptance notice, can choose 1 qualified provincial health care departments to declare, for enterprises supplement submit approval documents 10 working days after complete network, a declaration, the national traffic, speed up the innovation medicine to enter the market.

 Improve the price of innovative drugs and medical insurance access policies: establish and improve the initial price formation mechanism of newly listed innovative drugs, and allow them to refer to the pricing of similar international drugs. In the medical insurance negotiation access, priority should be given to the application of varieties in the catalogue, and policies should be given to the qualification of medical insurance access negotiation, improving the willingness of medical insurance payment, and reducing the price reduction in new indications or renewal. Optimize the price formation mechanism of medical insurance negotiation, and the negotiated base price should not be lower than the complete cost including research and development costs. The official initial pricing plan has not been released, there is news that it is expected to be implemented by the end of this year, two opinion revisions have been completed before, wait and see, and some provinces are already testing the waters

 Explore the establishment of new ways of medical insurance payment for innovative drugs: encourage key areas to set up special funds for supplementary payment for innovative drugs. For the varieties in the application list, the clinical demand, fund payment power and price difference in drug negotiation are be considered in the medical insurance negotiation, and the qualified varieties will be added into the medical insurance.The medical insurance fund shall be paid in advance. After the annual liquidation of the medical insurance fund, the payment amount of relevant varieties in the current year shall be counted, and the difference shall be supplemented through the special fund and the period shall not exceed two years.

Improve the diversified payment guarantee system for innovative drugs: support qualified commercial insurance companies to use medical treatment and medical insurance data in accordance with laws and regulations to develop commercial health insurance products covering innovative drugs.

(4) Enrich the support channels for the investment and financing of innovative drugs

 Maintain the sustainability and predictability of the implementation of the listing policy of the Science and Technology Innovation Board, retain the capital market financing channel for the unprofitable innovative drug enterprises, and continue to support the qualified innovative drug enterprises to become stronger through the ipo, refinancing, merger and reorganization, and make use of the capital market.

Resources are limited, and medical insurance funds are also limited. When more resources are given to innovative drugs, there is no doubt that other products (mainly generic drugs) will be weakened. These are related to the strategic layout and project approval of enterprises, so we really need to make more efforts to ponder and think. For example, if the project is only based on the present, unless there is the wisdom and foresight to predict the future, it is likely that when the product comes out in three or five years, the policy may have turned 180 degrees, so more to look at the present based on the future. From now on, we medical people should always be in awe of the medical policy, because the change is really too fast.