Global HealthPharmaceutical Regulations in Japan

JPMA's Activities for Access to Medicines in Developing Countries

September 23, 2016
Japan Pharmaceutical Manufacturers Association
President, Yoshihiko Hatanaka

The issue of intellectual property rights and drug prices as barriers to access to medicines in developing countries has been discussed in the United Nations High-Level Panel on Access to Medicines which concluded its work by issuing a report on September 14, 2016.

The Japan Pharmaceutical Manufacturers Association (JPMA) recognizes that there are multi-layered challenges in addressing global access to medicines. It requires a solution with a holistic approach including ensuring financial resources for health systems, promoting research and development (R&D) of medicines, establishing healthcare infrastructure, supporting capacity building of healthcare workers and improving health literacy. Together with major pharmaceutical industry associations, JPMA made recommendations to the Panel based on the industry’s experiences and efforts to improve access to medicines.
(http://www.ifpma.org/resource-centre/un-high-level-panel-on-access-to-medicines-submissions-a-b-c-26-february-2016/)

Although the Panel was a crucial opportunity to discuss critical issues regarding global access to medicines, it is regrettable that the recommendations noted in the Report are based on a narrow perspective and not presented in a well-balanced manner.

JPMA’s perspective and the activities of member companies on each of the items related to the access to medicines in developing countries are described below:

1. Intellectual property rights and access to medicines
JPMA believes that R&D of new drugs is essential in improving global access to medicines in developing countries. When achievements of R&D are protected appropriately under a patent system, it enables pharmaceutical companies to continue R&D and invest in the commercialization of their products. We need to carefully administer the current patent system so that it does not lose this incentive for innovation.

The members of JPMA fully recognize the importance of delivering therapeutic drugs for neglected tropical diseases (NTDs) as well as for infectious diseases such as HIV infection, tuberculosis and malaria to patients in developing countries. JPMA member companies are contributing to improving access to medicines by developing therapeutic drugs for these diseases as well as strengthening clinical infrastructure and health systems through public-private partnerships, on the assumption that the results of R&D are protected under the patent system. In addition, if it is judged that it is essential for improving access to medicines, the appropriate procurement of medicines can be facilitated by the flexible use of patent rights such as the exercise of rights and voluntary agreements for licensing conditions.

In cases of public health emergencies such as pandemics, JPMA member companies fulfill their corporate social responsibilities by collaboratively working together with countries, organizations and companies throughout the world to provide necessary medicines to patients, regardless of the status of patent rights.

While JPMA considers that a fair pricing system by which drug discovery innovation is properly assessed on the basis of price is essential for continuous invention of innovative new drugs, JPMA is also aware that the prices of drugs affect access to medicines in patients in developing countries where the average income per person is low.

In such situations, JPMA member companies continue efforts to ensure access to medicines for many patients in need through approaches such as tiered pricing, by which the price is set depending on affordability, and drug donations.

2. Promotion of research and development
Some may argue that pharmaceutical companies are not interested in investing in R&D of new drugs for diseases which may not attract interest in developed countries and regions. JPMA supports a program for sustaining R&D of such drugs through the collaboration of industry, academia and government. Through this program, JPMA member companies continue their efforts in R&D of new drugs for diseases mostly prevalent in developing countries such as NTDs.

3. Establishment and maintenance of healthcare infrastructure, capacity building of healthcare personnel and improvement of health literacy
PMA recognizes that the major barriers to access to medicines are the lack of healthcare insurance systems, insufficient clinical infrastructure, shortage of human resources and training opportunities, as well as low health literacy.

Being aware of these challenges, JPMA and our member companies will continue to contribute to improving access to medicines in developing countries, through rebuilding and strengthening clinical infrastructure, supporting practical instructions and training for capacity building, and facilitating disease awareness activities through collaboration with stakeholders such as governments, organizations and corporations all over the world.

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