Topics Held a regular meeting with the French Association of the Pharmaceutical Industry (Leem).

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The European and American Subcommittees of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) hold annual meetings with the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Association of the British Pharmaceutical Industry (ABPI), the French Pharmaceutical Manufacturers Association (Leem), and the German Association of Research-based Pharmaceutical Industries (vfa) as part of their activities to resolve international issues in cooperation with European and American governments and pharmaceutical organizations. On November 23, 2022, the first face-to-face (+ online) meeting with Leem in three years was held and a lively exchange of views took place. The following is a summary of the meeting.

At the beginning of the meeting, Dr. Philippe Lamoureux, Chairman of Leem, expressed his pleasure to hold this meeting face-to-face with the Pharmaceutical Manufacturers Association of Japan (PMAJ) for the first time in three years. Given the enormous impact that COVID-19 has had on our industry, he introduced the meeting to first discuss pandemic preparedness and then to discuss the impact of Russia's invasion of Ukraine, as well as economic issues such as inflation and the huge spending on pharmaceuticals that is being seen in many countries around the world. The session will start with pandemic preparedness.

During this session, the European Commission gave an overview of how the European Health Emergency Preparedness and Response Agency (HERA) was established in September 2021, and how it will strengthen the existing European Center for Disease Prevention and Control (ECDC). He also introduced the Trips Waiver for the COVID-19 vaccine, which has been difficult to negotiate because the French government supports both patent protection and technology transfer, although Leem has expressed its opposition.

In this session, based on the experience of COVID-19, the strategy for vaccine development and production system was taken as Japan's countermeasure against future pandemics, and efforts such as the emergency approval system and the operation of the Strategic Center for Advanced Research and Development (SCARDA) were introduced.

In this session, he introduced France's priorities in the wake of Russia's invasion of Ukraine, which include ensuring the safety of French citizens in combat zones, securing medical supplies, and fighting inflation. It was then introduced that Leem had made an urgent proposal to combat inflation in April 2022, and that negotiations were ongoing with the government to reduce the per-year burden of payment to the government, stabilize pharmaceutical prices, and secure energy supplies for the pharmaceutical industry.

The session opened with an overview of the French government's regime after Macron's reelection: the social security financing bill for 2023 includes items that will be tough for the pharmaceutical industry, such as the reimbursement of the portion of growth exceeding 0.4% and drug price reductions amounting to €830 million, which Leem estimated that the impact of these items would amount to about 3.5 billion euros, or 13% of total pharmaceutical sales.

During the question-and-answer session, the speaker touched on the change in funding for the procurement of medicines in France during a pandemic from the government budget to social security spending, as well as the handling of joint procurement in the European Union (EU). He also mentioned the financial problems that are hindering access to medicines in France and the need for the industry to unite and negotiate with the government.

At the beginning of this session, Mr. Kusakai, Chairman of the Subcommittee, gave an overview of Japan's "Kotto Policy 2022" and the current status of discussions on NHI price revision. He explained the need for reform of the NHI drug pricing system from the perspective of access to and stable supply of medicines under the circumstance that the number of unmarketed drugs is increasing due to the declining attractiveness of the Japanese drug market, and shared the status of advocacy activities by the Pharmaceutical Manufacturers Association of Japan (PMAJ) to the Japanese government. In the latter half of the session, Chairperson Ito shared the outline of the proposal for the G7 Hiroshima Summit 2023 and the status of its preparation.

During the Q&A session, questions were raised about the implementation process of NHI price revision in Japan, touching on similarities between the situations in France and Japan, and the government policy was answered, along with the situation of healthcare cost growth in Japan.

In this session, a detailed explanation of the early access scheme in France was given, including early access and compassionate access, requirements to be eligible for the scheme, the payback mechanism, and the actual application of the scheme. The presentation was followed by an explanation of Leem's position on the EU common HTA, which will start in 2025, as well as the current status and direction of various market access-related reforms.

During the question-and-answer session, the Pharmaceutical Manufacturers' Association asked how Leem perceives the early access scheme and whether there are any negative factors for companies. Leem stated that he was very concerned about the clawback system as a surcharge on companies.

Concluding Remarks

Ms. Sachiko Nakagawa, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), expressed her hope that the historic bilateral meetings between the two countries will continue to strengthen the cooperative relationship between France and Japan, now in its 28th year. He also noted that both countries share the same issue of NHI drug prices and that the Pharmaceutical Manufacturers Association of Japan (PMAJ) will continue to pay attention to the policy trends in France. He also proposed that the next meeting be held in Japan after the G7 Hiroshima Summit in 2023. The meeting was again a very meaningful one, where we were able to deepen our mutual understanding and actively exchanged opinions in each session.

( Masahiro Mizobuchi, Team Leader, France Team, Europe Group, Europe and America Subcommittee, International Committee)

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