Three Pharmaceutical Organizations: Joint Position on the Midyear Revision of NHI Drug Prices
November 22, 2022
Japan Pharmaceutical Manufacturers Association (JPMA)
Pharmaceutical Research and Manufacturers of America (PhRMA)
European Federation of Pharmaceutical Industries and Associations (EFPIA Japan)
The Japan Pharmaceutical Manufacturers Association (JPMA), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have jointly issued the following statement regarding the 2023 NHI mid-year price revision.
Background
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The three pharmaceutical associations believe in the importance of a drug discovery innovation ecosystem that supports scientific and technological progress for the benefit of Japanese patients and Japanese society, and the member companies of the three associations are constantly investing in the development of innovative new drugs.
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However, policy changes over the past few years have had a negative impact on R&D investment in pharmaceuticals in Japan. In other words, they have led to a situation in which NHI drug price levels for new drugs that are still on patent have not been maintained, which is necessary to enable reinvestment in the next generation of therapies.
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While the maintenance of NHI drug prices for new drugs during the patent period is a global standard, recent policy changes have resulted in a situation where Japan is behind in the evaluation of innovation.
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As a result, negative growth in the Japanese pharmaceutical market is predicted, weakening the attractiveness of the market for R&D investment and leading to an acceleration of the drug lag. Unless the factors impeding the growth of the pharmaceutical market are removed, Japan will face challenges in fulfilling its mission to deliver new drugs to patients in a timely manner.
- In order to overcome this situation, the following measures should be taken in the 2023 mid-year revision.
Comments on the 2023 Mid-Year Revision
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Despite the fact that maintaining drug prices during the patent period is the standard in major developed countries, drug prices have been revised for five consecutive years. Given the current situation where access to new drugs may be further impaired due to the declining attractiveness of the Japanese market, new drugs in the patent period should be exempted from the mid-year price revision and their prices should be maintained.
- In addition, given that the midyear revision is positioned differently from the regular biennial revision, the rules to be applied should be limited to those that were applied under the current system as "those that are linked to the revision of actual prices and compensate for its effects" as in the case of FY2021.
- In discussions on NHI drug price reform in FY2024 and beyond, in light of the current situation that is hindering the promotion of innovation and the securing of a stable supply of pharmaceuticals, the current revisions based on prevailing market prices should be fundamentally reviewed, along with appropriate evaluation of innovation and a mechanism to maintain drug prices during the patent term. The current revision based on prevailing market prices should be fundamentally reviewed, together with appropriate evaluation of innovations and a mechanism to maintain NHI prices during the patent period.
Organization Overview
Japan Pharmaceutical Manufacturers Association (JPMA)
The Pharmaceutical Manufacturers Association of Japan (PMAJ) is a voluntary association of 71 R&D-oriented pharmaceutical companies (as of October 1, 2022), which was established in 1968 under the motto of "realization of patient-participatory medicine" and has contributed to global healthcare through the development of innovative new drugs for ethical use.
The Pharmaceutical Manufacturers Association of Japan (PMAJ) is engaged in a multifaceted program of activities to solve various problems common to the pharmaceutical industry, to deepen understanding of pharmaceuticals, and to promote international collaboration. It is also committed to the healthy development of the pharmaceutical industry, particularly through the strengthening of policy formulation and advocacy activities, addressing internationalization, and enhancing public relations.
Pharmaceutical Research and Manufacturers of America (PhRMA)
PhRMA represents the leading R&D-oriented biopharmaceutical companies worldwide. Member companies strive to discover and develop new medicines so that patients can live longer, healthier, and more active lives. Member companies have invested more than $1.1 trillion in new drug research and development since 2000 and an estimated $102.3 billion in 2021 alone.
European Federation of Pharmaceutical Industries and Associations (EFPIA Japan)
Established in April 2002, EFPIA Japan is comprised of 23 European R&D-oriented pharmaceutical companies operating in Japan, EFPIA Japan aims to strengthen the dialogue with policy makers to improve healthcare in Japan.
Documents
For inquiries, please contact
Public Relations Department, Japan Pharmaceutical Manufacturers Association (JPMA)
- Phone
- 03-3241-0374
- Inquiry form
- www.jpma.or.jp/inquiry/
Public Relations Office of the Pharmaceutical Research and Manufacturers of America (PhRMA) (in Japan Counselors, Inc.)
- Phone
- 03-3291-0118
European Federation of Pharmaceutical Industries and Associations (EFPIA Japan) Public Relations Committee
Bayer Holding K.K. Yuko Kidoguchi
- Phone
- 03-6266-7757