5 October 2023

Press Release

EFPIA Japan

EFPIA Day 2023 Press Event
New EFPIA President Lars Fruergaard Jørgensen
talks about EFPIA’s Priorities under New Leadership
Outlined Europe’s important relationship with Japan

EFPIA Japan Chair Takahiko Iwaya
Delivers a Statement on the Drug Lag and Loss Issue in Japan- Establishing a platform to discuss the issue among multi-stakeholders in the healthcare community -TOKYO – 5 October 2023 – To deliver innovative therapeutics and vaccines promptly to improve thequality of life of patients, the European Federation of Pharmaceutical Industries and Associations(EFPIA, Brussels, Belgium) and European Federation of Pharmaceutical Industries and Associations
Japan (EFPIA Japan) put forth recommendations on the improvement of the drug development
environment and drug pricing systems.
At the EFPIA Day 2023 press event held today, new EFPIA president Lars Fruergaard Jørgensen
discussed EFPIA priorities under his Presidency and EFPIA Japan Chair Takahiko Iwaya
delivered a statement to address the drug lag and loss issue in Japan.
Lars Fruergaard Jorgensen discussed his ambition under EFPIA’s new leadership and hisPresidency.
As President of EFPIA, Lars Fruergaard Jorgensen delivered a speech on how to work together, for amore competitive, healthier and stronger Europe & Japan. He discussed EFPIA’s track record inworking with Government’s in Europe to develop pro-innovation health ecosystems and a commitment
to working with Japan.
Competitive. We believe that the competitiveness of our sector is an enabler for better health.
They are mutually reinforcing and require thriving life-science ecosystems with the right policy
framework, the right science, the right skills, and the right regulatory environment.
Healthier. New medicines bring hope to people that their lives, or the lives of those they love, canbe better. Easier. Longer.
-Stronger. Europe and Japan are innovative economies, highly interlinked. We need torecognise these strengths, and support stable trade flows at all times, and good collaboration intimes of crisis. By joining forces, the EU and Japan will be stronger together.

Outlining the importance of a strong relationship between the two regions at the event, Lars
Fruergaard Jorgnesen, said: I believe in the potential of our sector here in Japan and in Europe and in
the importance of collaboration between our geographies to develop the innovation of tomorrow tosupport stronger health systems, economies and societies. In my time as the President of EFPIA, I am
committed to working with everyone I can to help achieve this potential. As always, the first step ineach collaboration is an open, and continuous dialogue at the right level between public andprivate sector to achieve the change that is needed.”

EFPIA JapanTokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan- EFPIA Japan statement to address the drug lag and loss issue in Japan by EFPIA Japan
Chair Takahiko Iwaya
In Japan, the drug lag and loss issue are becoming increasingly serious. The increase in thenumber of pharmaceutical products approved overseas but not yet developed in Japan has caused
not only a “drug lag” where approval is delayed compared to overseas but also “drug loss” wheremultinational pharmaceutical companies are unable to conduct drug development in Japan. As aresult, despite the availability of promising therapies in other countries, patients who cannot receive
treatment in Japan are left behind, and there is also concern about the decline in the quality of
medical care in Japan.
EFPIA Japan considers that the following points are important to mitigate and resolve this issue.
For the NHI drug price system, a system with a high predictability that avoids the risk of suddenchanges in the system, so as to minimize adverse effects on plans for new drug development.
A system that enables the launch of new drugs in Japan without lagging behind the world's majorcountries and a system that can appropriately evaluate the value of drugs.
For the regulatory system, improvement of the clinical trial environment in Japan, elimination of
the pharmaceutical regulations unique to Japan, active designation of pioneering drugs, and early
initiation and approval of pharmaceutical review.
Promotion of patient participation in discussions to solve problems from development to postmarketing of new drugs by referring to examples from Europe such as EUPATI (EuropeanPatients Academy on Therapeutic Innovation).
EFPIA Japan believes that the drug lag and loss issue is relevant to all stakeholders involved inhealthcare in Japan. To solve the issue, it is necessary to mutually understand the positions of multistakeholders in the healthcare community, including patients, citizens, industry, government, andacademia, and discuss solutions. EFPIA Japan is committed to leading resolution by providing a placefor multi-stakeholder dialogues.
Contents of “EFPIA Day 2023 press event”
Date: October 5, 2023 Venue: Nihonbashi Hall
On Thursday, October 5, the European Federation of Pharmaceutical Industries and Associations(EFPIA, Brussels, Belgium) and European Federation of Pharmaceutical Industries and Associations,Japan (EFPIA Japan) held an EFPIA Day 2023 press event. In the first part of the event, new EFPIA
president Lars Fruergaard Jørgensen and EFPIA Japan Chair Takahiko Iwaya gave lectures. In thesecond part, Professor Kaori Muto, Department of Public Policy Research, Institute of MedicalSciences, The University of Tokyo, was invited to give a special lecture entitled "Patient and Public
Involvement (PPI/E) - Issues for Japan Learned from Europe."■About EFPIA Japan (http://efpia.jp/)
Established in April 2002, EFPIA Japan represents 23 R&D-based European pharmaceuticalcompanies operating in Japan. In 2022, combined sales from the member companies accounted forroughly 31% of the pharmaceutical market in Japan. The mission of EFPIA Japan is to “Contribute tohealthcare and patients in Japan through the early introduction of innovative medicines and vaccines”.
EFPIA Japan aims to strengthen dialogue with decision-makers in order to improve Japanese
healthcare for all.

EFPIA JapanTokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan■About EFPIA (European Federation of Pharmaceutical Industries and Associations)(http://www.efpia.eu)
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents thebiopharmaceutical industry operating in Europe. Through its direct membership of 37 nationalassociations, 40 leading pharmaceutical companies, and a growing number of small and medium sizedenterprises (SMEs), EFPIA’s mission is to create a collaborative environment that enables ourmembers to innovate, discover, develop, and deliver new therapies and vaccines for people acrossEurope, as well as contribute to the European economy.
■Media Contacts:●EFPIA Day 2023 Public Relations Secretariat: Oshima, Morita, and Takahashi
TEL: 03-6260-4861 E-Mail: efpiaj-pr@kyodo-pr.co.jp●EFPIA Japan Corporate Communications Committee: Ishikawa (Novo Nordisk Pharma Ltd.)TEL: 03-6266-1136

EFPIA JapanTokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan