20 keywords in the pharmaceutical industry in 2018
On the New Year’s Eve, there are many thoughts. I would like to make a summary at the end of the year and write a dedication at the beginning of the year, saying goodbye to the old and welcoming the new. It is lively, and everyone is very happy. However, the more you observe the changes in the pharmaceutical industry, the less you dare to sum it up rashly, and even less dare to prejudge trends lightly.
Recently, I have discussed intensively with industry predecessors, investment researchers and market peers in Beijing, Shanghai and Shenzhen to further clarify the thinking, and at the same time, I feel so. Therefore, you might as well write your thoughts as 20 key words, first write down the outline, throw a good idea, and then discuss this outline one by one if you have time.
The rapid growth of the industry reached a peak in 2012. After the GSK incident in 2013, it entered a new era. After two years of deliberations in 2013-2014, policy makers finally opened up a chapter in 2015. Policies followed and the industry continued to change.
This article does not list and analyze specific policies, but the possibility from policy formulation to policy implementation is presented through keywords.
After three years of adjustments from 2015 to 2017, the value reconstruction of the pharmaceutical industry has laid the following foundation at least at the policy level:
Through MAH, clarify the main responsibilities: production, quality, procurement, distribution, sales, and compliance with the agent's behavior. Each responsible entity has an ID, recode, develop a list of responsibilities, blacklists, and credit records, not only in the bidding and procurement process, but in the two-invoice system and MAH pilot.
Resolve 20,000 backlogs of approval documents + destocking for consistency evaluation + directional clearing of auxiliary medications, etc. Inventory of homes, clear inventory, remove the burden of unhealthy organisms, the first step in supply-side structural reform.
Forcing the removal of clinical trials suspected of falsifying clinical data + registration applications with obvious homogeneity. "Suspicious inventory" is rejected.
Speed up the review and approval of innovative drugs, children's drugs, and drugs that are in short supply. The reform ideas of red light districts, red light districts, and green light districts leave different paths for participants in different situations to encourage innovation, promote innovation, and reward innovation.
Revision of the Drug Administration Law + Consistency Evaluation + Re-evaluation of the Effectiveness and Safety of Traditional Chinese Medicine Injections + Standardized Names of Chinese Patent Medicines History is immutable and shock therapy is not advisable. While collectively paying for historical mistakes, it is also correcting, adjusting, and making up lessons. Those who attack policies are mostly the beneficiaries of historical mistakes, and those who ridicule policies are mostly those with limited power, and those who support policies are the best choice.
GMP/GSP flying inspection + combating clinical trial data falsification + process consistency verification (to be implemented). In order to maintain the results after the supplementary class, we must strengthen the supervision, and do not hesitate to overcorrect.
The two-invoice system separates the drug transaction chain between industry and agents. This is the core essence of the two-invoice system. The two parties to the transaction can only be industry-to-business (two-invoice system) or industry-to-hospital (one-invoice system), and there can be no redundant third-party drug transactions. In addition, the two-invoice system will definitely lower the price of medicines. If you don't believe it, wait and see, don't doubt it.
Fragmentation of drug procurement + complication of drug price formation + normalization of drug price decline. This "three modernizations" is the norm in three to five years. The valve of price reduction will stop if and only when the medical insurance fund can be controlled, the income of doctors can be stabilized, and the operation of the hospital can be sustained.
Three-medicine linkage + Fujian medical insurance office model + medical insurance in-depth intervention in drug pricing, procurement, and use. The medical reform must first find a breakthrough. The Sanming model has shown hope to the senior management. Since there are loopholes in Jiulong’s water treatment, the functions of various departments will be integrated; since the bidding still cannot find the true drug prices, the medical insurance payer must participate in the reform. The logic is like this. Don't doubt the Sanming island effect anymore. Now the islands have existed in series, it is hard to say whether they can become a continent in the future, but the strength and efficiency after integration will be strengthened, and industry professionals need to face it.