Year-end review: review and prospect of the new reform
The New Deal, which began in early 2015, has had the worst impact on the industry in history, although it was not drafted and published by the department of drug control. Followed by the industry as "7.22 tragedy" clinical data check list, the time clinical data verification in 2033 declared the production or import pending for drug registration, by the end of June 2017, the applicant voluntarily withdraw 1316 pending drug, the rest has been checked by 313 for drug registration, found 38 cases of clinical trial data on suspicion of fraud. One "check" aroused a thousand strong waves, the industry at one time the storm surge, the bemoans have it, the opponents have it, the beating of the heart.
Since then, two and a half years have passed since the publication of this paper. The new policy has not stopped, but also expanded and deepened. Nearly one thousand medical policy documents issued by national and provincial governments, including four major fields of medicine, medical care, circulation and medical insurance. In terms of research and development, there are mainly: self-examination of clinical data, priority review and approval, trial of drug listing license holder system, and participation in ICH; The production aspect mainly includes: generic drug consistency evaluation, elimination of GMP, flight inspection, environmental protection law, drug production process verification; In terms of circulation, there are mainly: centralized procurement of drugs, GPO, secondary bargaining, national drug price negotiation, drug price marketization, replacing business tax with value-added tax, two-ticket system, GSP, cancellation of approval for third-party pharmaceutical logistics business; Medical institutions use drugs mainly: limited auxiliary drugs, limited resistance; The reform of medical institutions mainly includes: separation of medicines, elimination of drug addition, drug proportion, adjustment of medical service prices, strict control of medical expenses, and trial reform of county-level hospitals. In terms of graded diagnosis and treatment, it mainly includes: medical consortium, regional medical resources sharing, and trial of graded diagnosis and treatment. The promotion of social medical services mainly includes: pilot family doctor system, social medical insurance, allowing doctors to practice more than one doctor; In terms of medical insurance, we will improve the financing mechanism and management services of medical institutions, delay the gradual retirement age policy, reform the way of medical insurance payment, development of health insurance, control of medical insurance fees, "four pooling arrangements", major medical insurance, direct settlement of out-of-town medical treatment, and the national network of medical insurance.
These centralized policies are aimed at the medical industry in the last two decades to form a solid disease, knife and blood. Up to the publication of this article, the new policy of this round of medical reform has seen a closed-loop logic of treating both the symptoms and root causes and abandoning turnips.
This round of medical reform is different from the past.
First, in the past, medical reform only changed medicine without changing medicine, so it was difficult to implement.
Second, not only the reform of medicine, but also the reform of payment methods, medical insurance, circulation, environmental protection, replacing business tax with value-added tax and other fields or projects, so as to make medical reform a systematic project.
Third, in the past, only the reform of the pharmaceutical industry has been focused on, while the pharmaceutical regulatory authorities and the new drug approval authorities have stayed firmly on the fishing boat.
Fourth, this round of reform has gnawed at the hard, but risky, bones of the past, including the drug market licensing system and the ICH.
The above analysis is from the policy level, and the fact from the actual operation level of the industry also tells us that the pharmaceutical industry is coming out of the confusion and the trough.
According to the data released by the ministry of industry and information technology, from January to September 2017, the main business revenue of the pharmaceutical industry increased by 12.3% year on year, and the profit increased by 15.8%, nearly three percentage points higher than the same period of last year.
From the perspective of the number of new drugs launched, known as a barometer of industrial development, by December 20, 2017, the number of 1 class chemical drugs undertaken by CDE has reached 199, an increase of 42% over 2016, which can be said to be an explosive growth. Self-examination of clinical data since 722 has not only failed to affect the declaration of new drugs, but also provided a lot of impetus for new drugs to be released.
The pharmaceutical capital market is as hot as ever. From October 1, 2016 to September 30, 2017, there were 725 cases of pharmaceutical mergers and acquisitions involving a total amount of 161.718 billion yuan. Among them, most mergers and acquisitions are concentrated under 100 million yuan, and there are 27 mergers and acquisitions with more than 1 billion yuan. Compared with the same period last year, the total number of cases increased by 77.7% and the total amount increased by 2.8%. This objectively reflects the increasing confidence of the capital market in the pharmaceutical industry.
From the perspective of macro-data and micro-industry management, the pharmaceutical industry is accelerating differentiation under the dual driving force of policy and competition. The innovative enterprises such as zhengda tianqing and hengrui pharmaceutical are leading Chinese pharmaceutical companies to take an innovative road combining imitation and innovation. And pharmaceutical companies, which have been scrambling to piece together scale and are unwilling to invest in technology and innovation, are in the doldrums. Drug companies that are not big enough to do it and don't have the innovation and core capabilities are declining.
From this point of view, the pharmaceutical industry is moving from a bad currency to a real survival of the fittest. Some organizations predict that a third of the pharmaceutical companies will be eliminated, I dare not speak out, but at this stage of pharmaceutical companies should make decisions early, or catch up with them or seek a safe exit early.
If this trend continues and continues to improve and improve, China's pharmaceutical industry will hopefully enter the ranks of innovation-oriented countries, and people will be more likely to use drugs with the latest technology.
Looking ahead to 2018, the author believes that in the face of all the good news, we should also see that the medical industry is still suffering from solid diseases and the innovative industry is far from being formed.
First, the current reform and new policies, although effective and systematic, have a strong flavor of administration and authority, and medical enterprises have only passively accepted them. If you can
The industry will be more confident in forming a legal system and reforms involving medical enterprises and medical institutions as well as the insurance and medical insurance sectors as a whole.
Second, people's medication is still at a low level. A comparison of the top 10 most used drugs in the world and China shows that the overall level of medication used by the Chinese people is still low, even when compared with the global average rather than developed countries.
Three, clinical institutions shortage, enthusiasm is not high, the standardization, the level is not high still does not have fundamentally solve the problem, at the same time complex regulatory approval and the lack of a unified and consistent standards, standards for admittance into clinical trials is too harsh, with a long cycle for examination and approval, the approval process after the change will be under a restricted part of new drug research. This is the biggest bottleneck in the current medical innovation ecosystem. If it can't be solved, it will affect the pace of new drugs listing by local Chinese enterprises.
Fourth, the innovation mechanism urgently needs to be integrated with all links. At present, the state encourages innovation, which can be realized by accelerating the review, but innovation is supported by market returns. At present, drug prices are too tight, it is difficult for new drugs to be listed in the medical insurance catalog, even though some new drugs have entered the medical insurance catalog, but it is still a rare phenomenon. The sales revenue of new drugs in developed countries can reach 1 billion to 1.5 billion us dollars (equivalent to 6 billion to 10 billion RMB) in about five years after the launch of new drugs in developed countries, while it can only reach 50 million to 150 million Chinese yuan in domestic market. However, it will frustrate the enthusiasm of pharmaceutical companies to innovate.
Under the background of the gradual clarity of the medical industry policy, rapid environmental change and competition upgrading, how can the pharmaceutical enterprises decide and decide the situation?
First, know yourself objectively. What are the clear advantages? What are the disadvantages? Where is the risk? Where is the opportunity? Where are the resources? Is it diversification or focus? One step at a time is wisdom in the past, and a trap in the present and future. There is more than one path to success, but for a specific pharmaceutical company, you cannot take multiple paths. You must choose according to your own conditions. In recent years, some far-sighted pharmaceutical companies have established their own industrial policies and established competitive research institutions. Some pharmaceutical companies use purchasing or customized methods to obtain such wisdom reports. But most drug companies are still reluctant to invest in information, feel dispensable and still make decisions based on hearsay.
Second, medicine is a long - term investment industry, where quick results and quick profits are not suitable for this industry. It usually takes more than ten years for a new drug to reach market maturity from seedling to market. It requires patience to cultivate and be able to sit on the bench. We envy the pharmaceutical companies that now have a class of new drugs on the market every year. They started to invest in new drugs more than ten years ago before the policy was mature.
At the same time, we need to see that China is a large country with a population of 1.4 billion and its development is extremely uneven. So generic drugs are still the main force in the pharmaceutical market, but they need to be made at a high level, with the same quality and efficacy as or even better than the developed pharmaceutical giants.
Over the past two decades, we have benefited from overmarketing, homogenizing products and homogenizing marketing. In recent years, research and development has become a major focus. It is to put marketing, research and development, human resources and technological progress in the same important position to operate, and the link between these key links is operation. If marketing is the leading force in the development of pharmaceutical companies, r&d is the ballast, and operation is the hidden support behind these links. Human resources are the driving force behind these links, and the leader is the key to the transformation of these links.
The inability of companies to grow is not uncommon in the pharmaceutical industry. We have seen some once-brilliant pharmaceutical companies hovering, mainly reflected in the slow growth of sales revenue, declining profits, the loss of key talents, the frustration of diversification or loss of blood. To change, these entrepreneurs need to start from their own, deep reflection.
From 2015 to 2017, medical professionals have more expectations and confidence in the pharmaceutical industry in 2018.