The World Health Assembly's resolution on transparency of drug market will affect drug pricing in the future

Recently, zolgensma, a gene therapy for spinal muscular atrophy (SMA) approved by the US FDA, came to the market, bringing light to SMA patients and their families However, with a price of 2.1 million US dollars per injection, zolgensma has once again set a new record of drug price, becoming the most expensive drug in history The market for new drugs for rare diseases is small, but it is precious for patients in need It seems reasonable to recover R & D investment with high price Some observers commented that there are two ways to look at zolgensma's new drug: "this is an amazing treatment, only a few children need it, so this two million yuan is not worth mentioning at all, or we are facing a situation where the biological pharmaceutical industry has completely turned to rare diseases, because this market seems to tolerate any price, while the FDA only requires special Less data " [1] Just at this time, at the 72nd World Health Assembly just concluded, after several days of anxious negotiations, representatives of various countries finally passed a resolution entitled "promoting the market transparency of drugs, vaccines and other health products", raising the market transparency of drugs, vaccines and other health products to the level of intergovernmental discussion The resolution calls for countries to strengthen the sharing of information about the actual price of medical products purchased by governments and other buyers to the public, improve the transparency of drug patents, clinical trial results and other pricing determinants throughout the value chain from laboratories to patients, and also requires the WHO Secretariat to support the work of transparency and monitor the affordability and accessibility of transparency to health products Impact, including on differential pricing The purpose of the resolution adopted by the world health assembly is to help member states make informed decisions when purchasing medical and health products, obtain affordable prices through negotiations, and ultimately expand the access of the population to health products [2] The resolution is a milestone document for governments and their public health systems in the field of drug pricing At present, many countries in the world (including developed countries in Europe and the United States) are facing the problem of "high drug prices, patients cannot afford drugs, and the government cannot afford to pay for them" The industry and the public all acquiesce to a premise: pharmaceutical industry is an industry with high technology risk and high investment threshold, but its success rate is low and its supervision is strict It needs to use the profits after the drugs are listed and sold to recover the huge investment in the research and development stage, including the cost of research and development failure, and create the capital source of technological innovation, otherwise the pharmaceutical technological innovation will not continue However, the composition and calculation methodology of R & D cost as well as other factors affecting pricing in the whole drug value chain are not completely clear or transparent, so it is impossible to judge whether the high pricing of a product is really reasonable Moreover, the public funds of various countries have invested in the early stage research and development of some pharmaceutical products in the form of subsidies or rewards, and the high drug pricing also limits or even prevents taxpayers from enjoying the technical achievements brought by the early stage research and development investment For the country, the transparency of the drug market helps the government understand the real R & D cost and pricing mechanism The government is not too passive in drug purchase or price negotiation Of course, the transparency of the drug market is ultimately a drug that can afford to cure patients and save lives Italy is the sponsor of the motion In early February this year, Italy sent a letter to the director general of who proposing to discuss the issue of "improving market transparency of drugs, vaccines and other health-related technologies" under the agenda of the 72nd World Health Assembly, "addressing global shortages and accessibility of drugs and vaccines", and attached a draft resolution Subsequently, the draft resolution was supported and co sponsored by 10 other countries (Greece, Egypt, Malaysia, Portugal, Serbia, Slovenia, etc.) and submitted to the World Health Assembly on May 20 Italy's draft resolution wants WHO Member States to: take measures to promote transparency in the drug and vaccine market; work with other Member States to develop minimum standards for transparency in clinical trial information and drug and vaccine research and development costs; and require annual reports on information on the following as a condition of drug and vaccine registration: --Sales revenue, price, and sales - marketing expenses - R & D expenses, including registration and fees for each clinical trial - product related grants, tax credits, or other public sector subsidies and awards The draft resolution has the support of some countries, but the United States, Britain, Germany, Switzerland, Denmark and other countries take a strong opposition position Most of the countries supporting the proposal are middle and low-income countries, and their governments are faced with how to use the limited public financial resources to solve the problem of drug access Even though the countries against the proposal are also faced with the challenge of high drug price and limited access, most of them have relatively developed pharmaceutical industry (so that some participants in the conference questioned whether the governments of these countries against the proposal are representative products Industry still represents the people After several days of standoff between supporters and opposition and seeking compromise in consultation, the resolution on drug market transparency was finally passed As far as the content of the resolution is concerned, it is obviously weaker than the original vision of Italy and other countries that want to create obligations for the pharmaceutical industry and require them to disclose all kinds of information related to drug pricing, but this does not affect the milestone significance of the resolution to open the discussion of drug market transparency The biggest achievement of the transparency resolution is that countries have reached an agreement that "appropriate measures should be taken to share the net price information publicly" Many countries are concerned about and expect the transparency of drug prices Each country's drug market is naturally divided, and the supervision of drug listing and use in each country also increases the difficulty of circulation The same drug is widely implemented with differential pricing (or price discrimination) in different markets in the world In addition, many pharmaceutical companies will sign confidentiality agreements with the government or large international drug purchasing agencies (such as UNICEF, global fund, etc.), requiring the government or the purchaser not to disclose the price of a certain drug agreed by both parties, so that pharmaceutical companies can still maintain high prices in other countries' markets This way of signing price confidentiality agreement is very common, but there are many problems If different countries share drug price information, it can certainly improve the bargaining power of the government and drug purchasing agencies Drug price transparency is the most basic requirement of drug market transparency The biggest failure of the resolution is the transparency of clinical trial cost Some countries represented by the United States (Alex Azar, Secretary of health and human services and former president of Eli Lilly) expressed strong opposition The main difference was whether to disclose the results and costs of clinical trials or just the results of clinical trials without the costs Countries opposed to the disclosure of clinical trial costs believe that, in terms of current practice, the cost of clinical trials is still a private domain management of pharmaceutical enterprises and an important investment in new drug research and development; however, countries supporting the disclosure of clinical trial results and costs believe that the disclosure of the calculation methods of research and development costs and research and development costs is helpful for the government to judge whether the drug price is fair and can be designed A better system to encourage innovation The final resolution was limited to the costs "already disclosed and voluntarily provided" in terms of the disclosure of clinical trial costs Even so, this resolution at least raised the issue of clinical trial cost disclosure, which has been kept secret all the time, which is conducive to public discussion and proper solution in the future Once a national regulatory agency takes the clinical trial cost as a compulsory disclosure obligation of registration in the future, drug regulatory agencies in other countries can learn from it according to their own conditions, which will also help to promote the transparency of R & D costs in the pharmaceutical industry and promote the rational pricing of drugs The transparency resolution itself will not directly lead to drug price reduction, but it does reveal the information asymmetry in the drug market and touch the key pain point of the pharmaceutical industry Any good governance system needs information transparency, and pharmaceutical industry should be no exception Reference [1] stat: at $2.1 million, newlyapproved Novartis gene therapy will be world's most expensive drug, by Adam Feuerstein, May 24, 2019 [2] https://www.who.int/news-room/detail/28-05-2019-world-health-update-28-may-2019