Retrospect and Prospect of Medical Reform New Deal
The current round of the New Deal started in 2015, and although the drafting and publication of the Environmental Protection Law is not the drug regulatory department, the impact on the pharmaceutical industry is the worst ever. Next is the clinical data self-examination by the industry jokingly called "7.22 massacre". The clinical data check involved 2,033 applications for registration of drugs that have been declared as being manufactured or imported. As of the end of June 2017, the claimant voluntarily withdrew 1316 Among the 313 applications for drug registration that have been verified, 38 cases of suspected clinical trial data were found to be counterfeit. A "search" aroused thousands of waves, the industry for a moment surging, those who lament there, opponents have it, there is nothing to pause.
Since then, two and a half years have passed since the publication of this article. The New Deal has not only stopped but is still expanding and deepening. Nearly a thousand medical policy documents have been issued by national and provincial governments, including the four major areas of medicine, medical care, distribution and healthcare. Among them, R & D mainly includes: self-examination of clinical data, examination and approval of prioritization, pilot program of drug listing and license holder, and joining of ICH. The main production areas are: generic drug consistency assessment, cancellation of GMP, flight inspection, environmental protection law and drug production Technology verification; circulation mainly include: centralized drug procurement, GPO, the second bargaining, the national drug price negotiations, the drug market, camp increase, two votes, GSP, canceled in the third-party drug logistics business approval; The main aspects are: limited aid medication, limited resistance; medical institutions are the main aspects of reform: separate pharmaceuticals, cancel drug additions, medicine, rationalize the price of medical services, strict control of medical expenses, county-level hospitals reform pilot; grading diagnosis and treatment Mainly include: Medical Association, regional medical resources sharing, grading diagnosis and treatment pilot; to promote social aspects of the medical system are: family doctor system pilot, the social medical insurance into the medical insurance, allowing doctors to practice more; medical insurance are: improve the medical Institutional financing mechanisms and management services, delayed progressive retirement age policy, reform of Medicare payment methods, development of health insurance Insurance, medical insurance control fee, "four co-ordination", serious illness Medicare, direct medical treatment in different places, medical insurance national network.
These concentrated policies and policies are directed at the solid diseases and knives that the pharmaceutical industry has formed in the past two decades. As of this publication until now, the current round of medical reform New Deal has been able to see a solution to the problem, abandoning the support of the closed-loop logic.
The current round of medical reform is different from the previous features are:
First, in the past, medical reform only changed medicine and did not change medicine, so it was difficult to implement it.
Second, not only medical reform but also medical reform, medical insurance, circulation, environmental protection, and business reform should be integrated into areas such as medicine and healthcare, so that medical reform can become a systematic project.
Third, the past only fixed on the pharmaceutical industry to change, and drug regulatory authorities, drug approval authorities sit tight fishing boat, the current round of medical reform is to change together;
Fourthly, the current round of medical reform chews up the hard bones that the industry is looking forward to but the risk is relatively large, including the drug listing permit system and the ICH.
The above is from the policy level analysis, and the fact that the actual operation of the industry also tells us that the pharmaceutical industry is out of confusion and trough.
According to the data released by the Ministry of Industry and Information Technology, from January to September 2017, the revenue from the main business of the pharmaceutical industry increased by 12.3% over the same period of last year, the profit increased by 15.8%, nearly three percentage points higher than the same period of last year, and the profit growth rate was higher than the scale growth and loss Faced with a 13.1% reduction, both the actual growth in scale and the quality of its operations are bullish.
Judging from the number of new drugs that fall into the barometer of industrial development, as of December 20, 2017, the number of category 1 chemotherapeutic drugs undertaken by CDE has reached 199, an increase of 42% over 2016, which can be described as explosive growth. The self-examination of clinical data since 722 not only did not affect the declaration of new drugs, but also provided many impetuses for the listing of new drugs.
Medical capital market unprecedented hot. From January 1, 2016 to September 30, 2017, a total of 725 pharmaceutical mergers and acquisitions took place in one year, involving an amount of 161.718 billion yuan. Among them, most of the mergers and acquisitions concentrated in less than 100 million yuan, more than 1 billion mergers and acquisitions case 27 cases. Compared with the same period of last year, the total number of cases increased by 77.7% and the total amount increased by 2.8%. Objectively reflect the capital market confidence in the pharmaceutical industry is growing.
From macroeconomic data and micro-industry management, the pharmaceutical industry is accelerating its differentiation under the dual forces of policy and competition. The innovative enterprises represented by CTT, Hengrui and other enterprises are leading the Chinese pharmaceutical enterprises to take a road of innovation combining imitation and innovation. The pharmaceutical companies, which have been massively busy and patchy and are reluctant to invest in technology and innovation, appear to be deteriorating and foggy. Pharmaceutical companies that are not well-established and do not have the capacity for innovation and core capabilities are declining.
From this point of view, the pharmaceutical industry is getting rid of bad money from bad money into the real stage of survival of the fittest. Some institutions predict that one-third of the pharmaceutical companies will be eliminated. I dare not make a vain remark. However, the pharmaceutical enterprises at this stage should make early decisions, or catch up with them or seek a safe exit early.
If this trend continues and improves and is being perfected, the Chinese pharmaceutical industry hopes to enter the ranks of countries that are predominantly innovative. People will have greater access to the latest technology and medicines.
Looking forward to 2018, the author believes that under favorable conditions, we should also see that the pharmaceutical industry still has a solid foundation for its solidarity and that innovative industries are far from being formed. We also need to continue to deepen the reform and continue to improve the policies we have already promulgated.
First, up to the present reforms and the New Deal, although the effect is good and systematic, the administrative and authoritative tastes are very strong. The pharmaceutical enterprises are still only passively accepting. If you can
The formation of the rule of law system and pharmaceutical companies and medical institutions, as well as insurance, Medicare departments to participate in the overall reform, the industry will be more confident.
Second, the people medication is still in a low state. A comparison of the top ten drug classes in the world and in China shows that the overall level of Chinese people's use of medicines is still low even when compared to the global average rather than the level used in developed countries.
Third, the lack of adequate number of clinical institutions, enthusiasm is not high, normative enough, the problem is not high enough to fundamentally solve the problem, while regulatory approval is complex and the lack of uniform and consistent standards, clinical trial access standards are too harsh, the approval cycle Longer, it will surely become the next restrictive link of new drug research after the approval period is changed. These are the biggest bottlenecks in the current pharmaceutical innovation ecosystem. If they can not be solved, the pace of listing new drugs by local Chinese enterprises will certainly be affected.
Fourth, the urgent need for innovative mechanisms linked with all aspects. At present, the state encourages innovation and accelerates the review and can achieve it, but innovation depends on market returns. At present, drug price control is too tight, listing new drugs into the medical insurance directory difficult, even though some new drugs have entered the medical insurance directory but it is still an individual phenomenon. In developed countries about five years after the listing of new drugs sales can reach 1 billion to 1.5 billion US dollars (equivalent to 6 billion to 10 billion yuan), while in the country can only reach 50 million to 150 million yuan, some new drugs long-term losses, of course This is also related to the domestic enterprises operating new drug methods and management level. However, this will in any event dampen pharmaceutical innovation initiative.
In the pharmaceutical industry policy gradually clear, the rapid changes in the environment, the competitive upgrade context, how to review the situation pharmaceutical companies, have the choice and decision?
First, understand yourself objectively. Where are the disadvantages? Where are the risks? Where are the opportunities? Where are the resources? Choose to diversify or focus on the road? Taking a step by step is wisdom in the past and a trap in today and in the future. There is more than one road to success, but you can not go more than one path for specific pharmaceutical companies. You must make trade-offs based on your own conditions. In recent years, some far-sighted pharmaceutical companies have established their own industrial policies and established competition research institutes. Some pharmaceutical companies use purchase or tailor-made methods to obtain such wisdom reports. But most pharmaceutical companies are still reluctant to invest in information, feel dispensable, still based on hearsay to make decisions.
Second, medicine is a long-term investment industry, quick successors are not suitable for this industry. A new drug from the young to market and then to market maturity often ten years, need to be patient to develop, to be able to sit on the bench. We envy each now a new type of drug listed pharmaceutical companies, to know that this is their ten years ago, the policy is not yet ripe for new drug investment, and today came to fruition, which is the victory of vision and common sense.
At the same time, we should realize that China is a large country with a population of 1.4 billion. Its development is extremely unbalanced. On the total amount it ranks as the second largest economy in the world. We are ranked below the average per capita and should not be blindfolded by the new era. Therefore, generic drugs are still the main drug market, but to do a high level of generic drugs, to be developed with the pharmaceutical giant has the same quality and efficacy even exceed them.
Over the past two decades over-marketing, homogenization of products and homogenization of marketing let us benefit from the moment, in recent years R & D has become the highlight, the systematic management is therefore particularly important, is the balance. Is to marketing, research and development, human resources, technological progress on the same important position to operate, and connect these key aspects of the operation. If marketing is the vanguard of the development of pharmaceutical enterprises, then research and development is the ballast, operation is behind the hidden support, human resources are the driving force behind these links, the head of the key to the above transformation.
The powerlessness of business growth in the pharmaceutical industry is not uncommon. We have seen some splendid pharmaceutical companies are hovering, mainly reflected in the slow sales growth, declining profits, the loss of key personnel, diverse setbacks or blood loss. To change, these entrepreneurs need to start from their own, in-depth reflection.