Medical network - February 13th February 9, the general office of the state council on further reform and improve the pharmaceutical production circulation use policy several opinions (hereinafter referred to as "certain opinions") officially released. The policy involves the production, circulation and use level of medical institutions, the path of the transformation and upgrading of enterprises has actually been very obvious.
"Certain opinions" will lead to the research and development, production, the price of enterprise management, flow distribution, and restructuring mergers and acquisitions, operations management, and other direction along with them, first layout can be dominant.
1, new drugs: attaches great importance to the clinical value of pressure on the financing side
New drug review once again offered to highlight clinical value, also is the "new" will not only limited to new drug compounds to new, still can ask clinical efficacy is currently listed drug curative effect is better and safer.
Difficult challenges there are treatments of disease areas will be larger, the future research direction will be more to no cure areas of development, such as has yet to conquer some segment of the tumor and the field of rare diseases, from the point of the market, the former heat only will be higher.
Countries will be based on the urgent clinical needs to speed up the review of the examination and approval of new drugs, the implementation of major drug discovery of science and technology major projects such as the national science and technology plan (and funds, etc.) special policy support new drug research and development. From the view of the current fund support, the state's fund support only leading domestic academy individual new drug projects through pre-clinical to obtain clinical approval stage. New drug clinical Ⅰ phase of the project need to enterprises as the leading units to undertake, but consistency evaluation need cost already accounts for 90% of most of the enterprise research and development costs, can spare capacity money do drug business will be very little. New drug clinical stage Ⅱ, Ⅲ fund pressure, preclinical and clinical Ⅰ phase of the project design is not reasonable cause many projects are unsustainable. How to solve the problem of financing projects and improve the quality of preclinical phase Ⅰ, is the key to improve the whole new drug projects. Enterprise preference decision for the project in the future, 2017 will be the new drugs and generic drugs enterprises of watershed.
2, generics: consistency and availability are very important
Since 2015, and speed up resolution of the drug registration since the backlog of problems, state is very clear to the requirement of generic drugs, wants domestic generics and branded drug quality and curative effect.
In addition to the quality requirements, the state also has asked for clinical value, especially drug accessibility aspect, mainly displays in: drug approval to speed up the review for the shortage; Required patented drugs for prevention and control of major diseases, if necessary, may, in accordance with law, compulsory license; In order to protect children, the elderly and other groups and major disease prevention and control of drug demand, exploring the rare diseases, children, the elderly, urgent (rob) save for examination and approval of drugs such as classification review.
Enterprise for generic project choice: one is to choose the product sales is bigger and the base of patients with more products, such products tend to be most companies focus on product, the competition results will eventually is the result of cost competition. This means that the master key costs such as upstream active pharmaceutical ingredients and raw materials, and key technology manufacturers, will be more likely to gain advantage in competition. Another is to differentiate themselves, such as shortage of generic drugs, rob to copy patented drugs needed for prevention and treatment of major diseases.
"Certain opinions" is put forward for the first time for through consistency evaluation of drugs will be included with the original drugs are drugs directory. In addition, accelerate the reference preparation in the need to import to import approval, improve customs clearance efficiency. The bioequivalence test records management; Allow qualified medical institutions, institutions of higher learning, scientific research institutions and other social testing organizations in accordance with the law to carry out consistency evaluation of bioequivalence test policy, is all good consistency evaluation of incentive mechanism.
"Certain opinions" is put forward from the aspects of system and the process to speed up the measures to solve the problem of drug registration application backlog, such as food and drug supervision departments to enrich the review power, strengthen the guidance of enterprise development, establish an effective communication with applicants advance mechanism; Strengthen the clinical trial data verification, punish data fraud behavior; Comprehensive information publicly for examination and approval of drug approval, strengthening social supervision and so on. This means that the future research and development will be more and more transparent information, enterprise reporting will be more and more rational, helps to reduce duplication of declaration.
3, production: process inspection is 2017 flight check point
Production quality control is the most critical, "several opinions" is put forward to strengthen management enterprise change medicine raw materials, production process adjustment, etc, and require companies to fully validated. With CDE listed chemicals production process change research technical guiding principles, chemical process inspection will be 2017 flight check point.
Shortage of drugs, cheap drugs production availability, will be able to pass a health family planning, the ministry of industry and information technology, business, food and drug supervision departments work closely, improve the shortage of drugs, cheap drugs monitoring and warning and grading coping mechanism, establish and improve shortage collect, transmit, analysis, drug information consultation system, dynamic master key enterprise production situation, as a whole to designated production, pharmaceutical reserve, emergency production, negotiate, adjust measures to ensure drug market supply, intends to go differentiation strategy of the enterprise can take into consideration the layout of the related products.
4, price management: deep platform unicom and information sharing
The resulting price information platform will not just empty said. National drug supply security integrated management information platform and the provincial drug centralized purchasing platform will be standardization, drug purchase data sharing becomes possible, and drug centralized purchasing platform (public resources trading platform) information will also be connectivity and medical insurance payment platform, even with the tax data to be Shared.
In addition, the price is not only a platform between the horizontal management, also asked for competitive price fluctuation in the inadequate drug for trace analysis. "Certain opinions" requirement to strengthen monitoring insufficient competition pharmaceutical factory (port) price, the actual purchasing and selling prices and to analysis abnormal price change in time or with varieties of drug price difference is too high, when it is necessary to carry out special investigation cost price.
Production enterprises in the food and drug regulatory department under the lead of drugs ex-factory price information traceability mechanism, production enterprises to strengthen price management, because the false price of raw materials and pharmaceutical factory price of pharmaceutical production enterprise will be influenced by price, food and drug regulation, the tax departments of the serious investigation.
Price linkage is not only in the domestic price linkage between the provincial drug centralized purchasing platform, will also take price dynamic linkage with its neighboring countries, in order to realize the patent drugs and drugs have a patent issue in our country, sale price is not higher than the country of origin or goal of our country's peripheral comparable prices. Taiwan and Japan medicare drug prices are public, once collected, part of the original date medicine will hit.
"Certain opinions" mentioned will further improve the participation in the drug centralized purchasing medical institutions. This means that the medical institutions negotiation will be reasonable and lawful identity to a knife to cut drug prices. Encourage cross-regional joint procurement and specialized subject hospital, sanming drug prices will be more and more to follow the reform to the city.
Health care pay a price, "several opinions" requirement to speed up the pay standards on the basis of common name make health care medicine. Payment in fully implementing health care reform or established medicare drug payment standard, allowing public hospital in the provincial drug centralized purchasing platform (provincial public resources trading platform) combined with quantity, purchasing budget. As of February 9, 2017, the domestic first proposed medicare payment and procurement of provinces are in fujian province, model of fujian province is expected to become "the health" the national implementation of the new star.
5, circulation and distribution: "medicine apart", enterprises need to prepare early
"Certain opinions" encourage patients to retail pharmacy to buy medicine: medical institutions will be effected according to the generic prescription drugs, and take the initiative to provide prescription to patients. Prescribing information of medical institutions, health care billing info and drug retail spending will connectivity, real-time sharing of information. Clinic patients to choose from in the medical institutions or retail pharmacy to buy medicine and not restricted by medical institutions. Medicine separate means that part of the medical institutions will peel outpatient pharmacy, also means that the layout of the production enterprises to their products for channel management as soon as possible.
"Two votes" open is no longer a Wolf at last, in 2017, comprehensive reform pilot provinces (autonomous regions and municipalities) and the reform of public hospitals pilot cities will be pioneering, 2018 will be opened all over the country. Production enterprises in the short term concern how and drug distribution enterprises and medical institutions to establish perfect paper between purchasing and selling drugs, accounts, goods, payment for goods is consistent, along with the goods the process of single with drugs.
Enterprises need to focus on "Internet + drug circulation channel development, especially in medicine circulation enterprises and the development of the Internet online integration between enterprises, new retail pharmacy retail services such as Internet" net book store take "" net book store" and other new distribution way, it might be new channels, new opportunities.
6, restructuring mergers and acquisitions: the policy orientation of production and circulation
Restructuring mergers and acquisitions mainly aimed at the production and circulation enterprises, the goal is to improve the industry concentration degree, support way of merger and reorganization, push backward enterprises, large enterprises pursue scale, small and medium-sized enterprises pursue professional characteristics of differentiation.
For manufacturing enterprises, the group within the cross-regional transfer product licensing examination and approval procedures will be simplified, policy tend to encourage original acquisition mode and equity investment. "Certain opinions" encourage drug marketing authorisation holder system pilot experience to pushed the country, especially to promote new products, new technologies and existing capacity and docking.
However, the marketing authorisation holder system execution progress information released limited: there are only shandong established the "supply and demand information platform, provide 105 willing to accept entrust production intent ability summary table; Published has applied for a marketing authorisation holder system reform pilot varieties list of provinces and cities in Shanghai only. Jiangsu province announced on February 8, 2017 listed on the license holder system pilot to combined to carry out consistency evaluation of 270 varieties of information.
Medicine circulation enterprises, mainly through breaking pharmaceutical products market segmentation, local protection, to promote the drug circulation enterprise cross-regional merger and reorganization, cross ownership; Through the integration of drug storage and transportation resources, to achieve more warehouse together; Eventually form with large backbone enterprises as the main body, small and medium-sized enterprises for complementary medicine circulation network between urban and rural areas. In addition, also encourage pharmaceutical circulation enterprises to participate in the international drug purchase and marketing network construction, promoting the development of large circulation enterprises toward the internationalization direction.
In 7, compliance operations: marketing face short-term test
Enterprises need to attach importance to marketing system management of the contract, the contract will be formulated by the health to family planning, business and other departments to contracts. Drugs production, circulation enterprises to ensure that the drugs in time production, distribution, medical institutions, such as purchasing side to settle payment in time. As companies distribution will blacklist not in time, the enterprise should be timely follow up the contract details. Drug procurement paper management also want to develop toward standardization and electronic.
Under the reform of health care costs, drug, consumables, examine the original belong to the income of medical institutions, will cost into medical institutions and drug dosage will return to rationality. Companies will start to face multiple layers of channel control money before the sales return to "pure pin" sales fell cliff type. How to dependence on channel control money withdrawal ever, to speed up the terminal marketing actual sales of medical institutions, will be the enterprise Marketing Department and medium-term face problems.
On behalf of the management requirements of strict medicine -- "a medical representative will implement records, and can only be engaged in the promotion, technical advice and other activities, shall not be responsible for drug sales". Here the sales task is not the same as sales target, more refers to "the drugs management quality management standard" mentioned in the "sales". Drugs to promote the compliance of the primary impact is the agency system enterprise, such enterprise will be reforming related operation management system.
conclusion
"Certain opinions" marketing for pharmaceutical production circulation enterprise puts forward "clinical required, drugs and, channel differentiation and operation compliance" proposition, the path of the transformation and upgrading of enterprises in fact has been very obvious. Only can choose a suitable own in policy guidance in the direction of enterprise development, planning, form a complete set of feasible solutions and implement in place of the enterprise, to remain in the evolution is king. |
