An article to understand the pharmaceutical policy dividend in the end how much

Medicine Network December 4 hearing I often heard, and sometimes just a few days, due to the introduction of the New Deal involving the medical system and the consolidation and improvement of the relevant system, the pharmaceutical industry will have a great change since 2016-2017, the policy release intensive , Overwhelmed a few years later and may have changed in recent years is the reason for the emergence of a watershed in the industry.But we must clearly recognize that the opportunities and challenges brought by the policy and system are coexist and accurate Judging future trends and opportunities, we must understand the status quo in the industry one by one, we must make a correct interpretation of the newly released policy promptly in order to plan ahead as soon as possible to establish business strategy.

The author extracts the main context and perspective from a variety of perspectives, depth analysis of the various concerns of the industry and answers to questions, and make their own judgments on future trends for the industry counterparts for reference.

1. Globalization: The pharmaceutical market in China has been integrated into the global market and has become a core strategic market for multinational pharmaceutical companies, and the entire Chinese pharmaceutical industry has increasingly become more globally compliant with its code of conduct and standards.

2. Industry consolidation: horizontal and vertical mergers and acquisitions trend highlights: API and preparation of the joint review and approval of drugs and medical instruments Production, distribution and medical institutions, the industry chain up and down the extension and extension.November 15, Shanghai Pharmaceutical Group acquired the United States Kant Lok China is by far the history of China's pharmaceutical business, a merger, leading to the pharmaceutical business Sales leading the first three significantly improved the concentration of the same November 30, announced the NUS Pharmacy Walgreens Boots Alliance, 40% of the shares for nearly 2.8 billion expansion of funds, which will enable the pattern of pharmaceutical retail is likely to accelerate the development of internationalization .

3. Innovation: The National Series encourages innovation policies, improves quality and strictly approves innovative drugs and medical devices. Enterprises are increasingly required to build a technology platform in order to find out their new core competitiveness.

4. Economics: In order to prevent health insurance fund deficit and strengthen economic requirements, the pharmaceutical industry is less affected by the economic cycle fluctuations. However, improving the economic characteristics of pharmaceuticals has become an important factor in building core competitiveness.

5. Competition: The competition between pharmaceutical industry and healthcare service in China is more reflected in the breakdown of 'micro' market. Different types of cities, medical institutions and enterprises show different competitive landscapes.

6.Customers: Traditional marketing methods are generally promoted mainly by doctors. However, with the development of information technology and the popularity of social media, the rapid development of the Internet will make patients and payers more and more influential on consumer outcomes.

With the deepening of the social aging, self-care awareness and the rise of low-level labor force, the market for health needs will increase.Government support for high-end pension can be formulated in line with the policy of large health planning, the rapid use of medical investment.

To build on information, to do big trade e-commerce, Internet food and drug operations need large logistics, standardized development of third-party logistics.

With the State Council deepening the reform of the medical and health system as the center, the pharmaceutical industry development plan as the goal; to develop the entire industrial chain for the purpose of rapid development towards large-scale, intensive direction.

Through the medical platform and retirement pension platform, the state-owned funds, shareholders' funds, insurance funds, private funds and the development of the pharmaceutical industry will be opened up and integrated into the capital flow of the "two-vote system."

Take the financial services of large circulation enterprises (such as Sinopharm Medicine and Shangyao) as an example. At present, some hospitals have serious arrears, and the large circulation enterprises have the involvement of commercial banks and financial services to ensure that the pharmaceutical factories can get back their funds in time. Among them, There are two kinds of financial services: First, the financing model after the delivery, the supplier can apply for financing after the delivery to the state control to solve the cash-strapped account problem. Second, the advance payment model to cater to the 'two-vote system' To solve the problem that the pharmaceutical factory must receive the advance payment before delivery, the value-added services provided by the medicine on the payment of money are also a way to provide strong financial security.

Figure 1 The major problems facing the pharmaceutical industry

Consistent evaluation, pharmaceutical companies are facing reshuffle; drug bidding, two votes and 'second bargain'; pharmaceutical exports, the situation is not optimistic; Internet +, the road to development is difficult; growth of the main industry revenue less than 10% Become the norm; drug trial reform vigorously boost new drug research and development; environmental protection for the pharmaceutical industry; mergers and acquisitions in the pharmaceutical industry unabated.The eight key variables have a significant impact in the formulation of corporate product strategy and technology introduction, you need to carefully consider.

◎ Drug Innovation: The reform of new drug registration and approval (such as MAH), industry concentration promotion are innovative drugs, high-quality generic drugs tilt, need to pay attention to accessories and medicine packaging materials related review of the New Deal (November 30, CFDA official website Notice on Adjusting Examination and Approval Items of APIs, Pharmaceutical Excipients and Pharmaceutical Packaging Materials, canceling the approval of packaging materials and containers (hereinafter referred to as pharmaceutical packaging materials) for pharmaceutical excipients and direct contact with pharmaceuticals, APIs, pharmaceutical excipients and Drug packaging materials in the approval of drug registration application for approval together.); Grading diagnosis and treatment (long prescriptions, prescription extension) led to the growth of primary hospital dosage.

◎ Medical Equipment: Encouraging the localization of equipment, the new demand of primary hospitals will become the growth driver of the medical equipment industry.

◎ private capital: to encourage private capital into the field of medical services, specialist, high-end and third-party service market usher in the development of spring.

◎ 10 independently set-up medical institutions: The will of the social forces to invest in these fields is very strong and will strongly stimulate the investment vitality of social forces.

◎ immunotherapy: is considered to be the most likely cure for cancer, a technology currently the most effective, including immune checkpoint inhibitors and chimeric antigen receptor T cell immunotherapy - CAR-T, will cause cancer clinical treatment The changes may lead to the shortening of the life cycle of anticancer drugs and the structural changes of clinical drugs.

◎ Circulation of medicines: Trend of informationization and service-oriented, traditional distributors turned their business to supply chain management, resulting in new modes such as DTP, GPO and PBM and expanded profit margins.

◎ private hospitals: focus on planning to lead, open up space for social forces to do medical treatment; implementation of policies to encourage and support for the social forces to create a development environment; stimulate Entrepreneurship Vitality, cultivate a new format for the development of the industry; establish a system of registration and information, so that social forces to share high-quality resources, improve the industry access management.

◎ Growth of the pharmaceutical industry slowed down. The growth rate is expected to be maintained at 8% -10% (2015 growth rate 9.0%, 2016 growth rate 9.9%, growth rate 12.39% in the first half of 2017).

◎ Large-scale and intensive guiding policies have forced the industry to speed up the transition of SMEs across borders (especially in the areas of price declines, rising costs (including manufacturing, R & D and sales), access standards, circulation and reshuffling, and adjustment of drug use structure. Various types proxy Business).

◎ research drug Innovative drugs, biopharmaceuticals and high-barrier generic drugs are still full of potential. MAH will accelerate the breakthroughs in new technologies and new products, change the research and development model, and promote the rapid development of CROs and CMOs.

◎ Chinese-made drugs approved by the EU, the United States or Japan but not listed in China are expected to be exempt from clinical direct marketing.

◎ internationalization of pharmaceutical companies is the trend of the times, including not only the formulation of exports, but also including overseas mergers and acquisitions and international cooperation.

◎ new technology and new model to lead the future, medicine E-commerce (online prescription drugs subject to government restrictions must consider the new direction), Internet chronic disease management, precision medical treatment is still the front.

The reason why this issue is concerned is because the API is "raw material" or "raw material medicine." If the raw material medicine, you can do MAH, so drug technology transfer, etc .; If the conclusion is only raw material, I am afraid Not qualified.

In fact, the API is nothing more than an active pharmaceutical ingredient and can not be administered, so it is not appropriate to refer to it as a medicine, but if it is to be changed, the Drug Administration Law will be amended. And this Amendment to the Drug Administration Law (Draft of the draft) "is only partial changes, the definition and classification of drugs, the entire chain of drugs and life-cycle management is not yet covered, so for the time being to retain the API reference .Next, the" Drug Administration Law, "a comprehensive revision It is very likely that the concept of API will be abolished.

The author believes that the impact of the implementation of the "associated review" on the pharmaceutical excipients industry is reflected in the following three aspects:

First, the market environment is more regulated and the scale of the industry is expected to expand rapidly, and it is expected that the ratio of pharmaceutical excipients to the domestic formulation industry will rapidly increase, the market scale of the industry will rapidly expand, and the era of hundreds of billions of pharmaceutical excipients market will soon come.

Second, the redistribution of pharmaceutical excipients market, large enterprises will usher in a new round of expansion of domestic pharmaceutical excipients to be January 1, 2018 in accordance with the new submission of information to the food and drug administration to submit information, with reference to the new To declare the information, the minimum quality standard is 2015 Pharmacopoeia and need to provide a stable production process.The implementation of the associated review and evaluation policy will lead to redistribution of pharmaceutical excipients market, industry concentration has been increased.

Third, to promote the internationalization of domestic pharmaceutical excipient enterprises To meet the individual needs of customers of pharmaceutical excipients, is expected to stand out in the consistency assessment is expected to produce a number of domestic real and imported accessories comparable to the quality of products International accessories business.

Businesses also need to consider the meaning of the phrase 'drug product applicants should be responsible for the quality of APIs, pharmaceutical excipients and drug packaging materials'. "In addition, the impact of drug consistency reviews on pharmaceutical excipients has drawn the industry's attention. Consistency assessment to improve the quality of auxiliary materials and technical requirements, the pharmaceutical auxiliary materials to enhance the same position with the main drug, reversing the 'heavy raw materials, light materials' situation.

◎ grading treatment continue to deepen, the primary drug market can be expected

Hierarchical medical treatment was listed as the top priority of the 13th Five-Year Plan for Health Care Reform, and the scope of pilot projects was further expanded in 2017, requiring expansion to over 85% of the cities. With the sinking of medical resources and the unification of medicine catalogs, The market is gradually valued, sinking channels has become one of the strategies of pharmaceutical companies.

◎ a number of measures simultaneously, forcing hospital charges, some drug sales trapped

In recent years, the change from "price reduction" to "control fee" has been obviously changed. In particular, the measures such as medical insurance payment mode and medical insurance payment standard reform, control of medicine proportion, promotion of clinical path management, negative prescription management of prescriptions and monitoring of auxiliary medication As the representative, in the set-mining price increases continue to increase at the same time, some auxiliary medication, cost is not high, the efficacy of imprecise drug sales are facing difficulties.

◎ medical joint body building, bargaining power should not be underestimated

On the one hand, the government is an important way to realize the grading diagnosis and treatment and improve the service capability of grassroots medical institutions; on the other hand, in order to reduce the price by combining the purchase demand of medical institutions and purchasing bargains, At present, the medical establishment in the whole country is in full swing. Enterprises should pay close attention to the substantive progress of the construction of medical associations in all provinces.

◎ Complete abolition of drug addiction, affecting the medical terminal medication ecology

By the end of September this year, all public hospitals will completely eliminate drug additions and drugs will change from income to costs. Public subsidies should not be put in place until public subsidies are available, or pressure will be passed on by further reducing drug purchase prices, etc. Based on the effect will be more inclined to choose the cheaper drugs set up the Medical Association body, leading to the hospital bargaining power to strengthen the business or will face a 'second bargain' predicament.

◎ improve the health insurance system, the new era of medical procurement and health insurance linkage

At a time when the issue of medical insurance payment is becoming increasingly prominent, the attitude of "letting the medical insurance departments participate in centralized purchasing" is also becoming more and more obvious. "The pilot project to set up a medical fund management center in 2017" has been mentioned in several national documents. Medical insurance and centralized purchasing Cohesion more compact.

◎ The "two-vote system" is in full swing and the rectification in the field of drug circulation is imperative

Two votes produced as the primary policy of circulation, for the pharmaceutical industry quite deterrent, mergers and acquisitions in the pharmaceutical distribution industry will usher in the climax, the industry leader will directly benefit from the environment, 'two votes system' will become the drug concentration Procurement requirements.But in the two votes to promote channel integration, the circulation of large-scale enterprises, upstream and downstream docking capabilities to strengthen, terminal bargaining power or will be relatively strengthened.