May 2023
EFPIA Japan

EU-Japan Health Innovation Forum 2023
- Partnering together for a sustainable health innovation system The

European

Federationof

PharmaceuticalIndustries

andAssociations(EFPIA;

headquartered in Brussels, Belgium) and EFPIA Japan organized the "EU-Japan HealthInnovation Forum 2023" on Wednesday 12 April 2023.
Held at the Europe House of the Delegation of the EU to Japan, the Forum was participatedby a broad audience both in person and online from Japan, Europe, the US and beyond.
Prestigious speakers from the EU and Japan government agencies, scientific societies andpatient associations, as well as the innovative biopharmaceutical industry, openly exchanged
their views on the importance of innovation in Japan and the potential opportunities forimprovements.

In the opening remarks, Mr. Hubertus von Baumbach, President of EFPIA, Chairman of theBoard of Managing Directors, Boehringer Ingelheim, set out the theme ‘Stronger together’and expressed his desire for the Forum to provide a platform for further collaboration instrengthening the health system efficiency and resilience.
Mr.

Takahiko

Iwaya,

ChairofEFPIA

Japan,PresidentandRepresentative Director, Sanofi K.K., stressed the importance of theyear 2023 for Japan. Japan assumes the G7 Presidency this year under
the leadership of Prime Minister Kishida. It represents a great
opportunity for Japan to showcase its commitment to human security
and universal health coverage. In such an important year, EFPIA
organized this Forum, for the first time, to discuss the importance ofpursuing innovation in healthcare with key stakeholders and partners.

1Featuring both individual presentations and panel discussions, the Forum enabled in-depth
discussions and exchanges of different perspectives from multi-stakeholders.

Part1 Individual Presentations on Initiatives Encouraging Innovation
In this session, four Japan and EU representatives from the biopharmaceutical industry andgovernment institutions shared their views.

As a representative of the innovative biopharmaceutical Industry in Japan, Ms. Kanako
Kikuchi, EFPIA Japan Board Member and Representative Director and President, UCB Japan
Co., Ltd., gave a presentation titled “Opening the future with the power of innovation”. She
defined innovation in Japan through the need of patients and outlined EFPIA Japan’s five
strategic imperatives to create and deliver innovation to patients. She also discussedconcerns and root causes regarding Japan’s declining market attractiveness, and called forthe development of a collaborative innovative ecosystem.
As a representative of the European / global innovative biopharmaceutical industry, Mr. Paul
Hudson, Chief Executive Officer, Sanofi, gave a speech titled “Opportunities to enhance
Japan’s global market attractiveness”. He reflected on the current situations in the UK andSpain, and proposed three important “wins” that should be swiftly implemented in theJapanese health system: 1) Ensure sustainable funding for innovation, 2) Improve thecurrent pricing system for higher predictability and better recognition of innovation, 3)
Improve the R&D environment and global regulatory harmonization to accelerate theintroduction of innovative medicines.
As a representative of the European Commission, HE Mr. Jean-Eric Paquet, Ambassador ofthe European Union to Japan, gave a speech titled “EU’s vision for innovation”. He mentionedthat the basic research for the COVID-19 vaccines was carried out in the EU, and the vaccines
were delivered from the EU to Japan in the early stages of the pandemic. In addition, heemphasized the importance of the strong relationship between the EU and Japan. To illustrate
the EU’s effort in driving healthcare innovation, Mr. Paquet referred to the European Health
Data Spce (EHDS), which will help the EU to achieve a quantum leap in the way healthcare
is provided to people across Europe. He also mentioned about the Horizon Europe Program,which supports scientific and technological excellence and strengthens the European2

Research Area. The Ambassador highlighted the current negotiations on Japan becoming anassociate member of the Program, and opportunities for collaboration with Japanese
academia and research institutions under this Program.
As a representative of the Japanese Government, Mr. Shinichi Isa, State Minister of theMinistry of Health, Labor and Welfare (MHLW) gave a lecture titled “Policies of promoting
innovation in Japan”. He said that constant promotion of innovation is a must to deliver
innovative new drugs to the country and to continue growing as an industry. The following
topics are currently being discussed by the Japanese Government:
1. Development of strategies related to the biopharmaceutical industrial policy,
2. Support of collaboration between academia and venture companies, and3. Creation of an environment that fosters innovations.

Part2 Dialogues; “The importance of continuously seeking innovations andexpectations for the future”
Four panelists from different backgrounds openly exchanged their views on two main
themes, "looking back at recent healthcare innovations" and "expectations for innovationsin the future".

Patient representative: Ms. Naomi Sakurai, Director of the Japan Federation of Cancer
Patient Groups,
Healthcare professional representative: Dr. Koji Watanabe, Executive Board Member of theJapan Medical Association,
Japanese government official: Mr. Katsufumi Jo, Assistant Vice-Minister for PharmaceuticalIndustry Promotion and Medical Information Management of MHLW, andIndustry representative: Mr. Kasper Bødker Mejlvang, President and Representative
Director, Novo Nordisk Pharma Ltd.
"Looking back at recent healthcare innovations"Ms. Sakurai: I appreciate the opportunity to participate in this kind of dialogue as a patient.
When I was diagnosed with cancer in 2004, Japan had a drug lag. Patients raised publicawareness of this problem and led the government to enact the Cancer Control Act andformulate the cancer control promotion basic plan based on the Act. Japan started to3

overcome the drug lag problem in a slow but consistent manner. However, there are still asignificant number of patients who die of diseases for which no effective treatments areavailable in Japan. I strongly hope that all relevant stakeholders reflect on patients' voicesin their discussions on healthcare innovations.
Dr. Watanabe: Compared to when I was practicing as a pediatrician, physicians now can use
a greater number of effective drugs for their patients. However, it is still difficult to conductclinical trials in children with chronic intractable diseases because of the small number ofeligible patients in Japan, and this situation remains unsolved for a long time. I think this is
an important issue that needs to be solved immediately.
Mr. Mejlvang: Patients’ voices motivate us to develop innovative new drugs. To continue drug
development, we must continue investment. In order to be able to boast that Japan is acountry that values innovation, it is necessary to maintain the price maintenance premiumfor innovative new drugs during the exclusivity period and to change the repricing system toreward the value of drugs rather than to reduce drug prices as the market expands. We
would like to participate in discussions with the Japanese government on pricing reform in aresponsible manner.
"Expectations for innovations in the future"
Mr. Jo: The Japanese government aims to ensure that Japanese people enjoy healthy lives
and a stable society. We believe that innovation in healthcare is very important. I expect
innovations will raise the level of conventional medical care. The expert panel in MHLW isworking on potential solutions to address current issues in Japan, and I believe that patientengagement and innovation are the keywords for solving these issues.
Mr. Mejlvang: We always think about how to respond to the needs of patients. In Europe,patient groups are even heard at the European Parliament, and I believe that the patients’voices are important to promote innovation and medical reform in Japan as well. Denmark
has a Public Private Partnership (PPP) program, which enables academia, medical institutions,
local governments, and policymakers to have comprehensive discussions together to solve
problems. I believe we must always be patient-centric.
Ms. Sakurai: I think we need visualization. The drug lag problem is there. Even thoughinnovative drugs with a dramatic positive impact on patients have been developed, some ofthem are not available in Japan due to drug pricing and regulatory issues. To manage within
limited financial resources, we believe that a drug discovery ecosystem that reduces waste
and moves toward the development of innovative drugs is essential. We would like to beinvolved in the discussion to build such an ecosystem.
Dr. Watanabe: We are aware that there are many innovative drugs that are not available inJapan despite they have already been demonstrated to be safe and effective in many othercountries. There are regulatory systems that help such drugs to be introduced in Japan. I

4expect

research-based

biopharmaceuticalcompanies

tocontinue

focusing

onthedevelopment of innovative new drugs, including the global companies that are present today.
Mr. Jo: I think that the importance of innovative drugs is being reaffirmed these days inJapan. Taking this opportunity to reconsider the supply of drugs, we are currently discussing
with the expert panel on potential solutions across the life cycle, from research anddevelopment support to regulatory affairs and drug pricing. I think it is necessary for patientsand people or end-users of medicines in Japan to understand this point. I would like to workon visualization and promotion of Patient and Public Involvement (PPI).

Conclusion
Although we are not yet entirely out of the COVID-19 pandemic and are experiencing
difficult geopolitical circumstances, we vow to never cease fighting for patients and people
across the globe through discovering and delivering innovative treatments and vaccines. As
long-lasting partners, the EU and Japan have helped and learned from each other, and willcontinue working closely together during this time of global turbulence.
Through the open and active exchanges among stakeholders across different backgrounds,
the Forum demonstrated a common understanding on the urgent need for a pro-innovation
health ecosystem, and the significant opportunities ahead for patients in Japan, the society,and the biopharmaceutical industry, both from Japan and the EU, to jointly achieveenhanced health security and economic prosperity.

Contact:
Masako Okamoto
Japan Joint Working Group, EFPIA
Tokyo Opera City Tower, 3-20-2 Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan
Sanofi K.K.
Mobile: +81 (80) 8078-5228
Email: Masako.Okamoto@sanofi.com

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