7月21日，国家卫健委等十部门联合部署开展为期一年的全国医药领域腐败问题集中整治，进行全领域、全链条、全覆盖的系统治理。据统计全国已有184位医院院长、书记被查，数量超过去年全年的两倍。同时，医药反腐波及多家药企，带金销售再次被推至风口浪尖。医药反腐将以医疗为核心，涉及药品、医疗器械购销领域，其中又以医疗领域关键岗位为主，但是否触发医改深化还有待观察。

1.重点在关键岗位。医药反腐在社会上造成较大震动，很多人担心打击了医务人员积极性，也有人说有些高质耗材的手术无法开展，寻常的学术会议也无法开展了。目前的反腐导向集中在六个方面：一是行政管理部门以权寻租；二是关键少数和关键岗位，以及药品、器械、耗材等带金销售；三是接受医药领域行政部门管理指导的社会组织利用工作便利牟利；四是医保基金使用的有关问题；五是医药生产经营企业在购销领域的不法行为；六是医务人员违反《医疗机构工作人员廉洁从业九项准则》。

2.反腐触及医改核心。此前我国进行了多轮的医改，其中十多年前推动过强基层、建机制的医改，希望提升最基层的医疗机构服务能力。但十多年来最基层的服务能力持续萎缩，二级医疗机构的服务能力也开始萎缩。而与之相对应的是公立三甲医院规模的逐年增加。防控新冠疫情中，我们看到三甲医院担心医疗挤兑，而下级医疗机构因为缺乏救治设备和能力无法正常接诊，很多民营医疗机构处于破产边缘。

医药以医疗为核心，与之相关的是药品、医疗器械、医保基金。医疗体系又以公立医院占绝对优势，其中公立三甲医院为塔尖，医疗资源高度集中，但资源高度集中却缺乏阳光的分配体制。资源垄断产生权力，权力滋生腐败。好的制度让坏人不敢使坏，坏的制度让好人也变坏。医改不在资源垄断上下功夫，要求医生尤其是关键岗位人员在各种围猎中独善其身，想杜绝前赴后继恐怕很难。

3.反腐不能根治医药腐败。医疗行业内常说，不关心医生待遇的医改必然失败。医疗行为高度专业化、信息不对称，医生在政策执行中具有决定性作用。国家对公立医院的定位是公益事业但又要求自负盈亏，自负盈亏但利润分配比例受控。这在逻辑上存在矛盾，是在回避医生的正常收入问题。既往的医改措施没有达到预期，一步步的改革如药品集中采购、限制药比、两票制、取消医院卖药加成、医保采购谈判，虽然在明面上降低了药价、切断了医药之间的联系，但是隐藏的带金销售持续存在。当医院失去药品收入但是诊疗收费没有变化的情况下，与之相应的检验检查就增加了。当严查过度检查的时候，轻症入院、分解住院又来了。当公立医院收入无法保障，医生冒险飞刀手术的情况就出现了。因此，不根据经济规律制订医改政策，希望用行政手段强压，甚至刑事法规震慑，只会按下葫芦起了瓢。

7月24日，国家卫健委等六部委印发《深化医药卫生体制改革2023年下半年重点工作任务》涉及事项二十项，包括公立医院主要负责人探索年薪制，注重医务人员的稳定收入和有效激励，让广大医务人员获得阳光有尊严的报酬。文件的出台，应该是对医生正常收入呼声的一个回应。但方案中高薪养廉仅限于医院负责人，是否能够杜绝腐败存在怀疑的声音。

若结合香港等发达地区以及其他发达国家经验，在存在贪腐的情况下依法取消其执业资格，也就提高了贪腐的违法成本，可以较大程度避免台底交易发生。而不满足于在公立医院合法收入的群体，可以选择自行创业或者流动到民营的医疗机构。而医生的自由流动，是民营医院能够发展壮大的核心因素。因此，在公立医院体系之外，应该形成具备一定规模的民营医疗市场。目前民营医疗市场极度萎缩，导致医疗资源无法从体制内流出，进一步加重资源集中。

民营医疗市场解决个性化的需求，因此在发达地区和国家他们商业保险的普及度更高。我国现在也在探索补充性商业医疗保险，比如深圳的普惠型商业补充医疗保险“深圳惠民保”，为基础医保没有覆盖到的一些领域提供保障，不仅对患者有益，也给医生、整个医疗领域提供积极支持。

4.医院需要合规顾问。2016年国家推行法律顾问、公职律师和公司律师制度以来，公立医院常规配备法律顾问。但是，目前的法律顾问一般局限于常规审核合同、处理医疗纠纷、代理诉讼案件，并没有在医院合规运行中发挥更多的作用，很难独立发表合规意见。公立医院目前设置部门和岗位，如纪检监察科，因不具有独立的第三方地位，也不具备专业的法律服务能力，还不能发挥应有的作用。而新形势之下，公立医院合规的需求持续增加，比如医疗信息数字化中的信息采集、保存、使用、第三方合作等都涉及合规。

2013年葛兰素史克事件后，作为医院供应商的药品企业持续加大合规建设的投入。大型的药企通过合规策划，建立核心在于真实性和合理性的合规体系，依法使用合规行政不处罚、刑事不起诉、刑事认罪认罚制度。这也是为什么在医院的受贿案件中，药企本身被波及的情况较少的原因。中伦文德律师事务所医药健康专委会这些年在药品生产经营合规方面形成了很多经典的案例。而深圳市龙岗区本轮医药反腐以来试点医疗合规，积累了非常好的经验。

5.反腐对药企的挑战。据统计，A股488家医疗企业去年共有3523亿元的销售费用，平均每家的年销售费用约为7.2亿元。有近40家A股医疗企业类销售费用占营业收入的比例超过50%。今年前5个月，而医保基金的支出增速同比增长23.3%，远高于收入增速8.2%。药企、医疗器械企业面临合规风险，全国300万医药代表人心惶惶。

之前的医改通过集中采购、两票制、取消药品加成、医保谈判挤出药价中虚高的部分，但是没有对药品销售采取一刀切的政策。但是伴随医药反腐的深入开展，结合2021年中央纪委、国家监委等印发《关于进一步推进受贿行贿一起查的意见》，药企的涉案范围可能扩大。因此，部分临床疗效不确切、带金销售的品种，可能因为医药反腐销量下降，甚至逐步退出市场。

6.是否可能医药分家。药品购销领域的顽疾可能影响到医药体制改革的方向。其实国家对药品领域的问题非常清楚，除了在流通领域挤水分外，前端通过药品上市许可制度促进真正有疗效的新药研发和生产，后端通过药品一致性评价去掉一部分疗效不确定的品种。但是对于有的发达国家推行的医药分家制度，一直存在疑虑。

医院目前不赞成医药分家，理由是医药自古不分家。在现有的医疗收费模式下，医药分家会直接影响到普通医生的收入。医院收入大致包括诊疗费、药品费用、检验检查费用。若药品服务相关的费用，包括隐藏的带金销售费用取消，而实际很难通过增加诊疗费体现医生的价值。而在现有的医保支付体系下，提高诊疗费标准会直接影响患者的就医体验，增加医保基金负担，因此医保政策不会冒险。

因此，有没有可能直接斩断医生与药品的联系呢？医生开具处方，处方仅仅注明药品的化学名，处方打印交给患者，由患者按照市场规则到社会药房购药。其实，国家早就推行处方流转制度，不过实际执行的过程中障碍很多。一方面医院药房和社会药房品种不同，另一方面医院处方常常电子化流转，患者也嫌麻烦不想拿纸质处方。药品的流转模式因为医院、药品供应商、患者之间的默契而维持了下来。

若患者凭标记化学名的处方购买药品，在哪里买药不知道，药品商品名不知道，也就不用冒险违法统方了，药品带金销售制度荡然无存。目前有公司推出医药物资供应服务管理平台，即SPD平台，实现医院与供应商间无缝信息对接，大大降低药品流通费用。医药分家的影响是，很多药品品种可能退出市场，而公立医院的医生待遇会下降。若与之相应的薪酬改革制度不能满足医生的需求，医生可以选择到民营医疗市场，这样医生流动就形成了，医疗资源垄断被打破。

7.反腐对国产医疗器械的机遇。进口医疗器械采购环节容易产生腐败，并且涉及的金额常常非常巨大，是腐败的重灾区。一方面，进口医疗器械的竞争优势非常明显，高中端医疗器械市场中占有率高于国产品牌，尤其是大型医学影像设备等高精尖体外诊断设备的差异最为显著。另一方面，根据中央纪、监委披露的云南普洱市的案例，高端进口医疗器械定价存在巨大的商业操作空间。目前，三级医院基本以进口医疗器械为主，二级医院进口占比近70%，国产医疗器械主要占据中低端市场。

据iiMedia Research以及《医疗器械蓝皮书》数据显示，我国目前已成为世界第二大医疗器械市场，并且正以每年10% 左右的速度攀升。预计到2025年中国医疗器械行业市场规模将达18414亿元。随着医药反腐在设备采购领域的推进，进口大型医疗设备的采购可能会受到影响，国产医疗器械迎来机遇。

国家一直推动国产医疗器械的发展，以深圳、广州为代表的中国高端医疗产业正在蓬勃兴起。2020年，深圳成立了国家高性能医疗器械创新中心，促进高端医疗器械的研发生产。2007国家财政部印发了《政府采购进口产品管理办法》，政府采购应当采购本国产品，确需采购进口产品的，实行审核管理。各地财政和卫健行政部门制订了进口医疗设备采购清单，在清单外采购进口设备等需要进行专门的论证程序，否则采购程序不合规。因此，医药反腐对国产医疗器械可能是一个发展的契机。但还需要考虑到，国产医疗器械的初创阶段需要股权融资，尤其需要相关投资基金的支持，政府主导基金的在人才配备方面有待加强。国产医疗器械注册后，在采购环节还需要获得更多的政策支持。

综上，律师观察认为，为期一年的医药反腐将围绕关键岗位展开，是否进一步扩大到药品、医疗器械相关企业以及普通医务人员还有待观察，能否促进医改迈入深水区还不清楚。我们还认为，医药反腐实际涉及医药体制问题，应该避免对医生污名化的倾向，反腐过程中对药企挑战居多，国产医疗器械或将迎来机遇。

（完）

英文部分：

On 21 July, the National Health Commission and ten other departments jointly deployed a one-year centralized rectification of corruption in the national pharmaceutical field to carry out a whole-field, whole-chain and whole-coverage systematic governance. In the meantime, the pharmaceutical anti-corruption affected a number of pharmaceutical companies, pushing sales with kickbacks to the forefront of the debate once again. The pharmaceutical anti-corruption campaign will focus on healthcare, involving purchase and sales of drugs and medical devices, mainly targeting key positions in the healthcare field. However, whether such anti-corruption efforts will trigger the deepening of the medical treatment reform remains to be seen.

1.The focus is on key positions. Pharmaceutical anti-corruption has caused a great shock in the society, many people are concerned about the blow to the enthusiasm of medical staff, but also some people say that some high-quality consumables operation can not be carried out, and ordinary academic conferences can not be carried out.  The current anti-corruption orientation focuses on six aspects: firstly, administrative departments use power to make rent-seeking; secondly, key minorities and key positions, as well as the sale of drugs, devices and consumables and other sales with kickbacks; thirdly, social organizations under the management and guidance of the administrative departments in the pharmaceutical field make profits by taking advantage of the convenience of their work; fourthly, the problems related to the use of the medical insurance fund; fifthly, the illegal acts of pharmaceutical production and operation enterprises in the field of purchasing and sales; sixthly, medical personnel violate the Nine Criteria for Incorrupt Practices of Staff of Medical Institutions.

2.Anti-corruption touches the core of medical reform. Pharmaceuticals take medical treatment as the core, and related to it are pharmaceuticals, medical devices, and medical insurance funds. The medical system is dominated by public hospitals, with public grade 3 hospitals as the top of the tower, and medical resources are highly concentrated, but in this highly concentrated situation there is a lack of a reasonable distribution system. Resource monopoly generates power, and power breeds corruption. Medical reform does not put efforts on the monopoly of resources, requires doctors, especially the personnel in key positions, to hold their own in various encirclement attack, it may be very difficult to eradicate the wave upon wave.

3.Anti-corruption cannot eradicate pharmaceutical corruption. Medical behaviour is highly specialised, information is asymmetric, and doctors have a decisive role in policy implementation. There is a contradiction in logic when the government defines public hospitals as public welfare, but it also requires them to be responsible for their own profits and losses, and has actually been avoiding the issue of normal income for doctors. Previous medical reform measures have failed to meet expectations, and step-by-step reforms such as centralized drug purchasing, restrictions on the drug ratio, the two-invoice system, the abolition of hospitals' mark-ups on the sale of drugs, and the negotiation of medical insurance purchases have lowered the price of drugs and severed the linkage between pharmaceuticals on the surface, but the hidden sales with kickbacks persisted. When hospitals lose drug revenue but there is no change in diagnostic and treatment charges, the corresponding tests and examinations increase. When excessive examinations are strictly investigated, mild admissions and decomposed hospitalisations come again. When the income of public hospitals cannot be guaranteed, doctors take risks in performing surgeries beyond the place of practice.

4.Hospitals need compliance consultants. Since the GlaxoSmithKline incident in 2013, pharmaceutical companies that are hospital suppliers have continued to increase their investment in compliance. Large pharmaceutical manufacturing and operating companies have established compliance systems centred on authenticity and reasonableness through compliance planning, and used compliance administrative non-punishment, criminal non-prosecution, and criminal plea systems in accordance with the law. This is also the reason why in the hospital bribery cases, pharmaceutical production and operation enterprises themselves are less affected. The Medical and Health Specialist Committee of ZLWD Law Firm has formed many classic cases in pharmaceutical production and operation compliance over the years. Besides, Longgang District of Shenzhen City has accumulated good experience in pilot medical compliance since this round of pharmaceutical anti-corruption.

5.The challenge of pharmaceutical anti-corruption to pharmaceutical companies. The previous healthcare reform squeezed out the inflated part of drug prices through centralised purchasing, the two-invoice system, the abolition of hospitals' mark-ups on the sale of drugs, and healthcare insurance negotiations, but did not adopt a one-size-fits-all policy for drug sales. However, along with the deepening of pharmaceutical anti-corruption, combined with the issuance of the Opinions on Further Promoting the Investigation of Accepting and Offering Bribes Together by the Central Commission for Discipline Inspection, the National Supervisory Commission and others in 2021, the scope of the involvement of pharmaceutical production and operation enterprises may be expanded. As a result, some varieties with uncertain clinical efficacy and sales with kickbacks may decline in sales or even gradually withdraw from the market as a result of the pharmaceutical anti-corruption.

6.Is it possible to split health care and drugs？Is it possible to directly sever the link between doctors and drugs? Doctors write prescriptions which merely indicate the chemical names of the drugs, and the prescriptions are printed and handed over to the patients, who then go to the social pharmacies to buy the drugs in accordance with the rules of the market. Patients buy drugs with a prescription marked with a chemical name, but it is impossible to keep statistics on where to buy drugs and what their trade names are, so there is no need to risk breaking the law to collect prescriptions, the system of selling drugs with kickbacks disappears. At present, a company has launched a pharmaceutical supply service management platform, that is, SPD platform, to achieve seamless information docking between hospitals and suppliers, greatly reducing the cost of drug circulation. The impact of the separation of medicine is that many drug varieties may be withdrawn from the market, while the treatment of doctors in public hospitals will decline. If the corresponding salary reform system can not meet the needs of doctors, doctors can choose to go to private medical institutions, so that the flow of doctors is formed, and the monopoly of medical resources is broken.

7.Pharmaceutical anti-corruption opportunities for domestic medical devices. The procurement of imported medical devices is prone to corruption, and the amount of money involved is often very large, and is the hardest hit by corruption. On the one hand, the competitive advantage of imported medical equipment is very obvious, and the market share in the high and middle-end medical devices is higher than that of domestic brands, especially the difference in high-precision in vitro diagnostic equipment such as large-scale medical imaging equipment is the most significant. On the other hand, according to the case in Pu'er, Yunnan disclosed by the Central Commission for Discipline Inspection, there is a huge space for commercial manipulation in the pricing of high-end imported medical devices. But in the context of pharmaceutical anti-corruption, it may be a good news for domestic medical devices.