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1. Environment Surrounding the R&D-Oriented
Pharmaceutical Industry
R&D-oriented member pharmaceutical companies of
JPMA have the mission to realize "patient-oriented health
care" by promoting innovative research to provide more
effective and safer drugs to patients faster not only in Japan
but also around the world, and this is also largely expected
from the society.
The pharmaceutical industry in Japan is an industry with
not only great potential for growth, but Japan is also one of
the few countries that have strong research and development
capability for new drugs, and therefore the contribution of
the Japanese pharmaceutical industry in promoting global
public health is large.
On the other hand, member companies of JPMA have long
undertaken international and social contribution activities.
One of the latest contributions is the financial support for
the establishment of the Pharmaceutical Development
Support Center in May 2009, which aids early development
and approval of novel drugs.
However, the business environment for member companies
has turned unfavorable in recent years. Domestically, the
growth of the Japanese pharmaceutical market has been
slowing due to constriction of the national health budget
and the gradual increase of generic market share.
Furthermore, the growth rate of the ethical drug market has
been stagnant in the global market, particularly in the US.
JPMA is carrying out a wide range of operations and
activities in accordance with the 5-Year strategy for
Creation of Innovative Drugs and Medical Devices for
building infrastructures to improve the environment for both
basic and clinical research to support new drug development,
which requires vast amounts of human and monetary
resources as well as time in the face of declining approval
success rates. Although these efforts have helped to advance
pharmaceutical research activities, the domestic
environment still has not been regarded as advantageous as
compared to that in foreign countries.
The national health insurance ("NHI") drug price list is
expected to be revised to substantially lower prices in 2010.
However, JPMA's proposal for the new drug pricing system
to set prices that reward innovation has not been fully
accepted by the government.
Furthermore, the "2010 Problem" will hit JPMA member
companies hard since the many of the major drugs
developed in the 90s are facing patent expiry.
It is also not easy to foresee how Japanese pharmaceutical
companies will be affected by the problems of drug access
and intellectual property rights in developing countries.
These problems became partly evident when the H1N1
virus broke out. The problem of drug access, either delayed
or limited, in treating not only diseases specific to
developing countries, but also chronic diseases has been
recognized as a major challenge to Japanese pharmaceutical
companies. Additionally, it is only a matter of time until
China, India, and other emerging countries catch up to
Japan as powerful competitors.
These major issues for the pharmaceutical industry cannot
be resolved by the industry alone. It is imperative to take an
in-depth view of the international situation and trends and
establish collaborative efforts among governmental
agencies, academia, and industry for action as part of the
national pharmaceutical industry strategy or economic
growth strategy.
Amid the new political climate in September 2009, the
Hatoyama cabinet of the Democratic Party started to work
with manifesto declarations that set out a 25% reduction of
CO₂ emissions, the abolishment of the late-stage medical
care system for the elderly, etc. Instantly, the execution of
supplementary budgets compiled by the Aso cabinet was
partly suspended and the proposed budget estimate for the
following fiscal year was reviewed; however, it is not yet
clear which direction the new cabinet will take on national
healthcare and pharmaceutical policies.
2. Business Policies
JPMA has many issues to tackle in the rapidly changing
environment as overviewed above. Social appraisal of the pharmaceutical industry appears to be generally positive,
but on the other hand, public concerns about drug safety are
becoming more apparent. It is important for the
pharmaceutical industry to implement strict compliance
with laws, corporate ethics, and with the JPMA Promotion
Code to improve further transparency of corporate
activities.
As for 2010, member companies, JPMA's committees, the
Office of Pharmaceutical Industry Research, and the
Secretariat Office will take collaborative actions in order to
implement the policies adopted in the 5-Year Strategy for
Creation of Innovative Drugs and Medical Devices, and to
further assist innovative new drug discovery, and will
deliberate actions on the following 5 issues in particular.
- Full implementation of the new NHI drug pricing system
proposed by JPMA
- Reinforcement of the infrastructure for research and
development, improvement of the clinical trial system,
and request for an accelerated drug review process
- Further promotion of international collaboration and
cooperation
- Development of new strategic approaches towards
environmental measures
- Promotion of public understanding of the roles of the
pharmaceutical industry, e.g., its contributions to public
health and national economic growth
3. Business Plans
JPMA will aggressively pursue optimal and practical
strategies to deal with a range of issues including the
following five major issues:
- Full implementation of the new NHI drug pricing system
proposed by JPMA
- JPMA will fortify its efforts to fully implement its
proposed new NHI drug price system, adequately
handle the discussion of the pricing system-related
issues, and improve the drug distribution system,
which is closely related to price recalculation of
drugs on the market.
- Reinforcement of the infrastructure for research and
development, improvement of the clinical trial system,
and acceleration of new drug approval
- JPMA will continue to urge the government to
implement the following policies and strategies by submitting proactive recommendations and providing
cooperative support.
- Lead the integrated management of a researchrelated
national budget instead of ministry-based
budget spending, including a stronger focus on
investment for the critical aspects of research
- Lead the implementation of the New 5-Year
strategy of Clinical Trials developed for the
improvement of the clinical trial and research
systems in Japan in order to achieve the optimum
shortest time to new drugs application
- Lead the implementation of the roadmap/annual
plan to improve the PMDA's clinical trial
consultation services and regulatory approval
procedures
- Lead the development and implementation of
certain policies and strategies for assisting
entrepreneurial pharmaceutical ventures to take
hold and grow further
- JPMA will appropriately take part in the national
safety assurance measures for marketed drugs in
cooperation with the government, medical
institutions, and pharmaceutical companies.
- Further strengthening of international collaboration and
cooperation
- JPMA will further engage in the support and
contribution to the IFPMA and participate in
activities for improving intractable issues of drug
access and intellectual property rights in developing
countries in concert with the activities of
international organizations such as the WHO and the
WTO.
- JPMA will cooperate with foreign organizations and
governmental bodies on assistance to developing
countries based on the Basic Principles of International Cooperation adopted in 2009. Also, JPMA will
join collaborative activities among China, South
Korea, and Japan and closely observe and support the
policy of "the East Asian Community" recently
proposed by the Japanese government.
- JPMA will promote international harmonization of
regulatory rules through a broad range of activities at
the ICH for global technological advancement, safety
evaluation and assurance from the R&D stage
through the post-marketing stage, and proper compliance of pharmaceutical companies to the new
product quality-assurance system.
- New approaches to national environmental measures
- JPMA will continue to evalute and discuss its contribution to the nation's strict environmental measures, particularly, those for green-house gas reductions.
- Promotion of public understanding of the pharmaceutical
industry concerning its contribution to public health and
the nation's economic growth
- JPMA will reinforce public relations activities to
promote understanding by the general public on not
only the importance of prescription drugs but also on
social roles of the R&D-oriented pharmaceutical
industry (for example, elevation of national standards
of public healthcare, enhancement of science level,
and contribution to national economic growth).
- JPMA will exert its utmost efforts to resolve drug lag
issues in collaboration with the government
organizations and the Pharmaceutical Development
Support Center for early market introduction of
unapproved new drugs and new indications
demanded by patients.
- JPMA will establish close relationships with the Diet,
government, business communities, labor unions,
medical associations, mass media, and patient
organizations through timely information dissemination and negotiation to obtain understanding of policies recommended and actions to be taken
concerning problems and issues that the pharmaceutical industry is facing.
- Reinforcement of activities to study and propose
pharmaceutical policies and strategies
- JPMA will establish, as early as possible, a forum for
discussion and resolution of the above-mentioned
topics and issues among the government, academia,
and pharmaceutical industry.
- JPMA will actively participate in, strengthen policy
proposals of, and utilize meetings at governmental
pharmaceutical affairs councils, in order to reflect the
opinions and ideas of the pharmaceutical industry in
government policies.
- Other activities
- JPMA, related committees and the Office of Pharmaceutical Industry Research will steadily carry out
activities based on the JPMA's business policies and
produce outcomes that will benefit the member
companies.
- The Secretariat Office will continue to take steps to
improve working efficiency and rationalize its
activities. The Office will steadily implement the
work improvement program adopted in Fiscal 2009.
- The Secretariat Office will determine the feasibility
of and study procedures for complying with the new
accounting system from Fiscal 2011.
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