6th July, 2016

To the media

EFPIA’s Statement on Secure Supply of Vaccines
European Federation of PharmaceuticalIndustries and Associations (EFPIA Japan)
Vaccine Sub-committee

European Federation of Pharmaceutical Industries and Associations (EFPIA
Japan, Chairman Carsten Brunn) Vaccine Sub-committee (Chair Jun Honda) has long
been making proposals on the future directions of Japanese vaccine business.
We hereby present EFPIA Japan’s position (statement) on securing stable supplyof vaccines, coinciding with July 6th “Vaccine Day”*. EFPIA Japan and the member
companies are committed to efforts and assistance to the Japanese authorities in order
to contribute to Japanese public health*The day when first modern vaccine was used on a human subject by Louis Pasteur

Contacts:
EFPIA Japan Public Relations Committee:
S. Honda (03-5786-5041), C. Saeki (03-6301-4147)
EFPIA Japan Secretariat
N. Saito (03-6301-3066)
EFPIA Japan Vaccine Sub-committee
J. Honda (03-5786-5159)__________________________________________________________________

6th July, 2016

EFPIA Japan’s Statement on Securing Stable Supply of Vaccines
1.

Vaccines manufacturing operations are complex and lengthy, and thusincreasing capacity in a short time frame is not feasible. EFPIA Japan believes
that the stable supply system anticipating the crisis situation needs to beestablished, and that measures should be taken to minimize risk and impact of
the crisis situation, before the crisis.
In the recent incidents related to GMP violation and earthquake disasters,
it has come as a reminder that vaccines with limited supply source(s), cannot
secure alternative supply source(s) and that even if they were secured, theproduction time required would be in the order of several months.
Therefore, for important vaccines like those in the NIP, we believe that bydiversifying supply sources to domestic and global sources (i.e. multiplemanufacturers) to co-exist, it would allow secure stable supply in Japan. Manyof the foreign manufacturers are global manufacturers, and we can maximize
the following advantages:
 Robust systems and processes with large manufacturing scale andinventory volume
 Geographically diversified network providing flexibility in ensuring
sustainable long-term supply even in the event of a crisis situation Meet regulatory standards of major regulatory authorities such as FDA, EUand WHO
For non-routine or specialty vaccines, we believe long term supply
purchase agreements and stockpiling are valuable means worthy ofinvestigation.

2.

Currently, there are differences in the manufacturing and release times between
domestic and import vaccines due to differences in regulatory requirements
between the two. This is a major burden on early introduction of vaccines fromoutside Japan and on release of vaccines into the Japanese market. EFPIA Japan
believes that it is necessary to promote harmonization of regulatory
requirements and to alleviate above burden in order to minimize stable supply
risk.

It would require a lengthy period of more or less 6 months for vaccines tobe released into the market after filling/formulation by the manufacturers.
During this time, quality testing and summary lot protocol review will beconducted, but by revisiting this process, e.g. by simplifying release processes(redundant quality tests and national tests) or conducting them in parallel, it
may become possible to accelerate without compromising product quality.
By harmonizing quality requirements with those outside Japan, webelieve that it would lead to faster introduction of new vaccines, and contributeto secure supply.
Collaboration between the government and the manufacturers would beindispensable during crisis management. EFPIA Japan and the member companies
are committed to efforts and assistance to the Japanese authorities in order to realize
more stable vaccines supply and to contribute to Japanese public healthEnds