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:

Responsibility

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.

Clearing

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.

Retreat

Forcing the removal of clinical trials suspected of falsifying clinical data + registration applications with obvious homogeneity. "Suspicious inventory" is rejected.

Quick batch

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.

Make up

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.

Accountability

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.

Cutting

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.

Bargain

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.

Integration

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.

shield

医药代表备案制，屏蔽不合规的接触和交易。医药代表持证上岗「9不得」、药企「4不得」、医生「9不准」，上海「三定一有」，受贿5000元开除，条条框框一大堆，尽一切所能拉开医务人员与医药代表的距离，切断药品交易链条。新入行的代表难了，老医药代表困惑了，但「老枪」没有任何改变，因为人家从来不去医院与医生接触。

以上是手段，重锤之下，对应的结果是或者将是：

补税

金税三期+两票制，只要有交易就需要上税、只要有收入必上税，唯税收与死亡不可避免。最大限度合理避税可以理解也需要学习，但奇技淫巧偷逃税款一定没活路。

微利

药品不再是暴利行业，大伙儿需要心态适应、方式适应、行动适应

退烧

抗生素、辅助用药、中药注射剂等大品种光环不再，市场趋于理性，一个时代就这么过去了。

淘汰

淘汰落后产能、淘汰僵尸批文、淘汰无法通过或放弃一致性评价的品种、淘汰旧有营销模式、淘汰与政策不符却不想改变的企业和个人。当前中国社会是「人民日益增长的美好生活需要和不平衡不充分的发展之间的矛盾」，而医药行业最大的矛盾恐怕是落后产能与政策要求、市场期待之间的矛盾，不淘汰落后产能、落后思想淘汰谁？

合规

合规成为必然、标配、活下去的必要条件。合规不是口号，合规不能产生生产力，但合规会保命、保住饭碗。只有活下去才能谈发展。无论外资还是内企，建立形势下的合规体系是当务之急，形式合规到实质合规是必由之路。

创新

药品创新、模式创新、监管创新，行业变得创新味趋浓。行业两股表现形态，一是保命，另一是创新，泾渭分明，高下立判，所以有人说2018医药行业进入下半场，头部效应明显。创新使得企业发展呈几何指数高速向前，而大多数传统产业特别是落后产能苦于解决眼下的种种棘手问题而陷入泥潭。

分化