Topics The "Regular Meeting with the European Federation of Pharmaceutical Industries and Associations (EFPIA)" was held.

She explained the four main points of the EU Pharmaceutical Strategy: (1) Learning from COVID-19 (crisis response system), (2) Ensuring access to medicines and affordability, (3) Sustainable innovation, and (4) Alleviating drug shortages and ensuring strategic independence. The four key points were explained. Regarding sustainability, the importance of the Green Deal and the Green Economy was emphasized.

During the Q&A session, the audience asked what issues and agendas EFPIA is prioritizing for advocacy, to which he responded that he would like to review the orphan and pediatric drug regulations, improve incentives, and revise the regulations. In addition, one of the themes of the Pharmaceutical Strategy for Europe is the disclosure of information on access and R&D expenses, etc. The participants exchanged opinions on the impact of these issues on Japanese companies, how the Pharmaceutical Association should respond to them, and advice from the EFPIA.

The EU-UK Trade and Cooperation Agreement (TCA), which was signed on December 24, 2020, came into effect on May 1, 2021, and the Mutual Recognition Agreement (MRA) for GMP inspections and the establishment of a working group on medical The TCA will come into effect on May 1, 2021, and there are welcome agreements for the pharmaceutical industry, such as the Mutual Recognition Agreement (MRA) for GMP inspections and the establishment of a working group on medical products.

During the Q&A session, he explained that continuing issues include ongoing discussions with the Association of the British Pharmaceutical Industry (ABPI). The letter sent by the ABPI to the UK and the EU regarding the UK's departure from the European Union (Brexit), for example, was very important to remind them of the concern that the UK and the EU will become less competitive in their global position, and that the ABPI would be grateful for their continued comments and cooperation on the ongoing issues. He also commented that he would be grateful for any input and cooperation from the pharmaceutical associations on continuing issues.

Regarding the South African/Indian proposal for an IP waiver related to COVID-19 starting in 2020, he explained the background to date and the schedule for future discussions at the WTO, including the US government's announcement on May 5, 2021 in support of the IP waiver and the status of opposition by EFPIA and other national pharmaceutical organizations. The WTO schedule for future discussions at the WTO was explained.

During the Q&A session, EFPIA explained that, in response to the U.S. government's announcement of support for the IP Waiver, it would cooperate with the ABPI, LEEM, vfa, and other European pharmaceutical associations, as well as with other industry associations, and with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the WTO. The use of data is becoming more and more important worldwide.

He also explained that the healthcare industry has not been able to create enough value through the use of data compared to other industries, although the use of data has been emphasized worldwide. He then presented the concept of the European Health Data Space (EHDS), in which the EU and EFPIA would work together to create an ecosystem that encompasses the entire supply chain of the pharmaceutical industry, and link this to innovation. In this session, he also presented a concrete schedule for the future development of the data and digital utilization infrastructure in the EU.

During the Q&A session, the participants shared the data utilization framework being promoted in the EU and the status of discussions in the EU regarding patients' personal data.

The Pharmaceutical Manufacturers Association of Japan (PMAJ) gave an overview of the Pharmaceutical Industry Vision, which is scheduled to be released by the Ministry of Health, Labour and Welfare (MHLW) in the summer of 2021, and explained the objectives and main contents of policy proposals issued by the PMAJ so far.

He then explained the efforts of the Pharmaceutical Manufacturers Association of Japan (PMAJ), based on the belief that "sound growth of the pharmaceutical industry is essential for the creation of vaccines and therapeutics from Japan" and "it is necessary for the industry to be positioned as a key national industry and for industrial policy to be promoted," and as a proposal toward these ends, the PMAJ will issue a "Vision for the Pharmaceutical Industry" in June 2020, which will include "the creation of drugs and vaccines to treat infectious diseases," and "the creation of vaccines for infectious diseases. In response to this, he introduced the "Pharmaceutical Association of Japan Proposal for the Creation of Infectious Disease Drugs and Vaccines" in June 2020 and "Pharmaceutical Association of Japan Policy Proposal 2021" in March 2021 as recommendations toward the creation of such drugs and vaccines.

During the Q&A session, EFPIA asked about the status of the establishment of the "Digital Agency" of the Japanese government and its efforts in healthcare, and the Pharmaceutical Manufacturers Association of Japan (PMAJ) responded to the timing of the establishment of the Digital Agency and the current policy announced by Mr. Takuya Hirai, Minister of State in charge of Digital Reform.

At the beginning of the session, the participants discussed the strengthening of collaboration and advocacy activities between EFPIA and the International Committee of the Pharmaceutical Cooperative Association (PPCA), with a view to cooperating with European governments and pharmaceutical organizations in activities to resolve international issues. The International Committee proposed the purpose and scope of the collaboration, after which EFPIA provided its opinions and advice, and the two parties discussed what kind of collaboration would be possible. We further confirmed the consensus of both parties and started the discussion by informing them that we would like to develop a six-month action plan or annual plan for the regular meeting in the fall.

EFPIA asked what the Pharmaceutical Manufacturers Association of Japan (PMAJ) had done to approach the Japanese government regarding the TRIPS IP Waiver, and the status was shared. EFPIA responded that the two parties would continue to discuss the TRIPS IP Waiver, and that they could cooperate with each other in the long term in terms of sharing best practices for digitization in healthcare.