Recommendationsof theEU-Japan Business Round Table
to the Leaders of the European Union and Japan
Rome, 28 & 29 April 2011

Working Party B
Life Sciences and Biotechnologies,
Healthcare and Well-being

Working Party Leaders:
Mr Hans-Dieter Hausner
President
Senior Bayer Representativefor Japan
Bayer Holding Ltd.

Mr Osamu Nagayama
Chairman of the Board of Directors
President & CEO
Chugai Pharmaceutical Co., Ltd.

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List of Abbreviations
Abbreviation Meaning
WP
EU
LS & BT
MRA
GMP
GLP
MAFF
NHI
MLHW
MOF
PMDA
HTA
FSC
CBD
ABS
IFAH

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Working Party
European Union
Life sciences and Biotechnologies
Mutual Recognition Agreement
Good Manufacturing PracticeGood Laboratory Practice
Ministry of Agriculture, Forestry and Fisheries
National Health Insurance
Ministry of Labor Health and Welfare
Ministry of FinancePharmaceutical and Medical Device Agency
Health Technology Assessment
Food Safety Commission
Convention on Biological Diversity
Access and Benefit Sharing
International Federation of Animal HealthRecommendations from both
European and Japanese industries
General Issues
WP-B / # 01 / EJ to EJ Enhancement of bio-venture activities
In both the EU and Japan, bio-venture activities should be enhanced further anddynamically integrated with each other. BRT members call for government support toexpand these networks of activities through such measures as bio-conferences orthe establishment of cluster centres. It is also necessary to support bioventures
financially under the current economic recession.
<Background>
In the biotechnology-based industries, bioventures have played an important roleto create innovative technologies and products. Bioventures in the EU and Japanare behind those in the US and need more collaborations or integrations between
venture companies. To realize this, expansion and activation of venture networks
will be very valuable. Under the current economic situation, it is difficult for
ventures to obtain capital from the markets. Some financial support should beconsidered to vitalize them.

Healthcare
WP-B / # 02 / EJ to EJ Regulatory harmonization and MRA for pharmaceuticals
The regulatory harmonization and further extension of “Mutual Recognition
Agreement” should be proceeded in order to avoid redundant inspections of
manufacturing facilities.
<Background>As currently only oral solid dosage forms are included within the MRA between
Japan and the EU, there are still a lot of redundant inspections of manufacturing
facilities. This is not only a costly process, but it also slows down the launching of
new drugs in Japan creating a significant disadvantage for Japanese patients.
In order to eliminate this problem and to integrate EU-Japan economics more
efficiently, harmonization of standards/guidelines and expansion of MRA should be
conducted under mutual agreements. Below-mentioned are highly prioritized items
for harmonization and expansion of MRA.
<Prioritized items for harmonization and MRA>
Harmonization:
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- Safety measures from surveillance to vigilance should be harmonized withinternational standards- Clinical development guideline and biological preparation standards for
Vaccine- Minimum Requirements for Biological Products
Mutual Recognition Agreement:- MRA of GMP should expand to liquids, and sterile forms, API and bio products toavoid redundant inspections and testing.

WP-B / # 03 / EJ to EJ Balance between prevention and treatment in healthcare
Seek balance between prevention and treatment. Thus, confirm inclusion of
vaccination programs and include contraception in the scope of public funding.
<Background>

Disease prevention and diagnostic/ screening procedures are getting a more
important position in healthcare area as they allow to improve the treatment of
numerous diseases but also to effectively lower the healthcare cost in mid- andlong-term. Therefore, vaccines and contraception should be in the scope of publicfunding.

WP-B / # 04 / EJ to EJ Mutual recognition of quality management audit results
for medical devices between EU and Japan
Start a mutual recognition of quality management audit results for lower risk medical
devices, e.g. those classified as Class II, ARCD under the Japanese Pharmaceutical
Affairs Law, as a first step.
<Background>
Based on Medical Devices Directive (MDD) of the EU and the JapanesePharmaceutical Affairs Law (J-PAL), Quality Management System (QMS) audit
results are required for each application for a license to introduce new medical
devices in the market. The current Japanese procedure requires manufacturers toprovide repeated QMS audits for each new product application or evaluation by adifferent certifying body. In Europe, the regular annual ISO audit results can beused for all applications during the period in which the ISO audit is valid.
As the Japanese QMS is based on ISO 13485 with only small modifications, itwould reduce the burden on manufacturers considerably if QMS audit results
would be mutually recognized, allowing European manufacturers to use the annual
ISO audit results for all applications during one year.

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WP-B / # 05 / EJ to EJ Mutual recognition of medical devices product licenses
Introduce a mutual recognition of medical device product licenses between the EU
and Japan<Background>
Mutual recognition of licenses for medical devices in Japan and the EU would
make it possible to introduce new products in both the Japanese and European
markets in the same time frame and with one process.
As mentioned before, it could be possible to start with lower risk, class II devices.
The evaluation scheme between the Medical Devices Directive of the EU and theJapanese Pharmaceutical Affairs Law are quite similar, with- Evaluation schemes based on registered 3rd party bodies (Notified Bodies)- Essentially quite similar requirements- Based on IEC or JIS standard compliance.
With these similarities, a mutual recognition should be easy to implement.

WP-B / # 06 / EJ to EJ Mutual recognition of clinical trial results for medical
devices
Introduce a mutual recognition of clinical trial results for medical device development<Background>
Differences in the definition of Good Clinical Practice between Japan and the EU
currently prevents the use of non-Japanese clinical trial results in the application
for new medical devices in Japan. Mutual recognition of clinical trial results would
make it possible to make new products available to patients in Japan and the EU
in the same time frame and through one process, ensuring high level of quality
while reducing the burden on manufacturers.

Industrial Biotechnology
WP-B / # 07 / EJ to EJ Strengthening activities for industrial biotechnology
To enhance the global competitiveness of the bio-based economy through increasecooperation between the EU and Japan, we suggest a number of actions that would
strengthen activities in the area of industrial biotechnology
9 Develop and implement EU-Japan common R&D programmes and strategies
to encourage use of agro-food by-products and wastes
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9 Support collaborative development of technologies to produce biomass based
products and sustainable biofuels
9 Benchmark the EU and Japanese policy strategies and legislation / regulations
in order to stimulate the market introduction of bio-based products frominnovative technologies
9 Set demonstration experiments of bio-based products in different environment
model areas in the EU and Japan to assess the possibilities and limitations of
the development and use of bio-based products
9 Encourage the introduction of composting systems to promote the use of biobased products and bio-based polymers
9 Consider common standards and certification systems for each productcategory between the EU and Japan to establish a global de facto standard forbio-based products
9 Set up a common task force to analyse which global incentives can stimulate
or support the re-conversion towards a bio-based economy

Plant Protection and Biotechnology
WP-B / # 08 / EJ to EJ Enhancement of cooperation with industry andacademia
Enhance international cooperation in the development of plants with new beneficial
traits / Promotion of industry & academia cooperation.

Potential Research Topics:
Genetic improvement of plant growth and yield to stabilize crop production invariable growth conditions by· enhancing plant gene discovery and regulatory network research· studying cellular growth and plant development· elucidating growth-promoting plant hormones
Healthcare
WP-B / # 09 / EJ to E Evaluation of innovation values for pharmaceuticals inpricesThe EU government should reinforce its innovation policy to member states andclarify its healthcare policy, resulting in the appropriate evaluation of the value ofpharmaceuticals.
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<Background>
In the EU, innovation policy is stated by the Lisbon declaration and the G10 groupreport indicating the importance of innovation in pharmaceuticals. However, eachstate operates its own healthcare system in different ways, resulting in gaps insurvival rates and the QOL of citizens. Under the current economic recession,prices of pharmaceutical products are targeted as a major tool for medical cost
containment. BRT members calls on the EU to clarify its healthcare policy and to
discuss and totally improve healthcare situations in member states by securing
appropriate healthcare budgets, preventing interference with patient access to new
medicines, and considering the proper utilization of healthcare technology
assessment.
Plant Protection & Biotechnology
WP-B / # 10 / EJ to E Shortening review times for products by plant protection& biotechnology
Shorten review times for new applications/ registrations.
<Background>Research and development of innovative and beneficial Plant Protection &Biotechnology products requires high input costs. Therefore, timely access to themarkets is crucial for the R&D-intensive companies in order to successfully market
their products and recover their initial R&D investments, which then again areused to finance further innovations.
Establishment and maintenance of science-based, predictable and timely
regulatory systems free from undue political influence and the appropriate
protection of proprietary data are therefore key requirements for sustainable andinnovative research.
Animal Health
WP-B / # 11 / EJ to E Introduction of “1-1-1 concept” for all animal healthproducts
Introduction of 1-1-1 concept for all products (one dossier – one assessment – one
decision on marketing authorization).
<Background>
One of the key objectives of the European Union is to create a single market forgoods. This goal has yet to be achieved for the animal health industry, with the
exception of centrally authorized products. In line with the concepts alreadyexisting in the EU (i.e. quality, safety and efficacy described in one single EU
dossier as the basis for granting marketing authorizations for veterinary medicinal
products, one single assessment of the dossier employing the best expertise,
resulting in one decision for marketing authorization) the animal health industry inWorking Party B
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Europe is seeking a systemic change based on the one, one, one concept (“1-1-1
Concept”) for all products. This appears to be the most simple and straightforward
way to address all of the major shortcomings of the current system and to finallyachieve the goal of a single market for safe and efficacious veterinary medicines.
Healthcare
WP-B / # 12 / EJ to J Nation-wide electronic database for individual
health/medical records in Japan
Map out the “grand design” of a nationwide electronically integrated database forindividual health/medical records as a basic Japan health policy<Background>
The Japanese government should intend to electronically integrate individual
health/medical care related data and information nationwide in order to supply
high-quality and patient-suitable medical care, and map out a “grand design” of thesystems. The integrated database will also improve the efficiency of medical careby eliminating duplicated examinations or reducing adverse events and treatment
for them. Furthermore, the data will be useful for the discovery of new innovative
medical treatments and devices. Several European countries have already taken
the lead on this issue, so Japan may be able to learn much from the experiencesof the EU.
WP-B / # 13 / EJ to J Citizens ID numbering system for social security in Japan
Commence non-partisan discussions on earlier introduction of citizens ID numberingsystem to provide better and impartial public services especially in social security
fields.
<Background>
The ruling Democratic Party of Japan (DPJ) clearly mentioned a citizens ID
numbering system in its “Manifesto” in the Lower House election in 2009. The
Japanese government will draw “Outlines for Social Security and Taxation Number(tentative)” by June 2011 and submit relevant bills to the extraordinary session of
the Diet in autumn 2011. The opposition parties positively agreed to start nonpartisan discussions on the introduction of this system, industrial organizations
such as the Federation of Economic Organizations (Keidanren) considers it
essential to develop a firm infrastructure, which can provide public services
impartially, certainly, transparently and effectively for realization of secure andaffluent society. The Japanese government proposed a policy that this ID number
will be applied to taxation and social security and allocated to citizens by 2013. For
privacy protection, personal data will be separately managed per category, suchas medical and nursing services.

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WP-B / # 14 / EJ to J Full-fledged implementation of the new drug pricing
system and abolishment of market expansion re-pricing
Finalize the implementation of the new, internationally competitive pharma pricing
system in Japan based on the industry proposal and abolish the rule of re-pricing bymarket expansion.
<Background>
The NHI price reform proposed by the industry has been positively reviewed by
the Chuikyo in December 2009 and the government decided to start a pilot
implementation in April 2010. This represents a significant improvement, as itprovides price stability for innovative drugs. As a compensation for this new
scheme, the government will attach a system that fosters the registration of“unapproved / off-label use drugs”. Companies have received requests ondevelopments of 181 unapproved / off-label use drugs and started forwarding
those constructively. The government should evaluate the companies’ efforts toeliminate the so-called drug lag in Japan and implement the new premium system
for innovative drugs at the 2012 drug revision.
Furthermore, we urge to abolish the current rule of the re-pricing by market
expansion, which is opposite to the policy to evaluate pharmaceutical innovation.

WP-B / # 15 / EJ to J Regulatory transparency and review time by PMDA
Increase the transparency of evaluation standards, / registration process andconsistent consultations & and shorten review time for pharmaceuticals and medical
devices by PMDA.
<Background>Innovation can contribute to improved patient quality of life, reduction of social costand robust industry growth. In order to precede with the proper evaluation andpromote innovation, transparency of evaluation standards and evaluation processes
should be guaranteed and improved by both governments. Adoption of healtheconomics/ HTA and establishment of a National Data Base for medication/cost are
essential for the improvement of transparency.
The increase of staff / personnel at PMDA in 2007, together with an increase ofregistration fee, is a welcomed move towards a reduction of review time. It is
important to continue to monitor if this will be linked with a significant reduction ofreview time. Also, it is suggested that Japanese authorities make more extensive useof overseas data, as this would significantly reduce cost and time required to register
products in Japan.

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WP-B / # 16 / EJ to J Measures against counterfeit products
Private imports of medicines provide a channel for counterfeits, mostly in OTC nonreimbursed drugs.

Plant Protection and Biotechnology
WP-B / # 17 / EJ to J Support to research for plant protection & biotechnology
Support research in Plant Protection & Biotechnology<Background>Research and development of innovative and beneficial Plant Protection &Biotechnology products is key to ensure safe food supply but also to increase theefficiency and therefore, the competitiveness of the agricultural sector.
To support this undertaking the governments should increase its spending for the
research in Plant Protection & Biotechnology.

WP-B / # 18 / EJ to J Efforts on increasing output of agriculture in Japan
Continue efforts towards increasing output production of Japanese agriculture<Background>
Japanese self-sufficiency on a calorie requirement basis is today below 40% sothat it can be reasonably expected that the food & feed commodity prices will
increase over the mid-long term. In addition, growing global population will also
continue to drive demand against increasingly limited supply.
To counter this negative development the Japanese government should reformand drive Japanese agriculture toward increasing output production, also by
utilization of biotechnologies, such as GMO’s.

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Recommendations from European industry
Animal Health
WP-B / # 19 / E to EJ Regulatory harmonization for animal health products
Further harmonization and streamlining of regulatory requirements for productregistration of animal health products<Background>
While such global new veterinary medicinal products go already through rigorous
review processes in Europe and the USA prior to registration, it requires
substantial additional testing in Japan under the Pharmaceutical Affairs Law
before an approval is granted. Regulatory requirements for an innovative
veterinary medicinal product based on biotechnology are especially stringent inJapan, and therefore, a product which is readily available to veterinarians andanimal owners in Europe cannot be used in Japan. Increased harmonization ofregulatory requirements would certainly improve access of animals and animal
owners to innovative animal health products.
An additional important aspect is the negative impact on animal welfare: since theregulatory requirements are not harmonized, the companies are required to repeat
tests on animals in Japan, even though results of identical tests are alreadyavailable and are fully compliant with stringent frameworks like GLP or VICH.

WP-B / # 20 / E to EJ Mutual recognition of GMP and marketing authorization
for animal health products
Mutual recognition of European and Japanese marketing authorizations andrecognition of GMP certification for veterinary products<Background>
While the studies conducted under Good Laboratory Practice or Good Clinical
Practice are usually accepted by the Japanese government for inclusion in thedossier, there is still no mutual recognition of Good Manufacturing Practice (GMP)for veterinary medicinal products. Moreover, any overseas production facilities thatare involved in manufacture of veterinary medicinal products imported into Japan
have to be accredited by MAFF even though their GMP status is authorized by
European authorities. This process involves a large amount of administrative
works.
In order to improve decreased speed, predictability and quality of the registration
process in Japan, which were pointed out in the benchmark surveys conducted by
the International Federation of Animal Health in 2007, several new steps wereWorking Party B
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taken by MAFF with some progress. However, there are still delays in review
process of some product segments. An EU – Japan Economic Integration
Agreement should aim for Mutual recognition of European and Japanesemarketing authorization for veterinary products by starting off with mutual
recognition of GMP certification of veterinary medicines. Harmonized regulations
on animal vaccines should also be addressed under such an agreement.

WP-B / # 21 / E to E Responsible use of antibiotics in animal health
Promote the responsible use of antibiotics in animal health<Background>
In common with the rest of the world, Europeans and Japanese are concerned by
the development of resistance to antibiotic medicines used in human health andthe potential threat that the use antibiotics in animal health will accelerate thisprocess. The use of antibiotics as growth promoters has been prohibited in EU
since 2006.
As a responsible industry, the animal health industry seeks to work withveterinarians, farmers and the feed industry to dispel the myths about the use ofantibiotics in animals and promote their responsible use.
Healthcare
WP-B / # 22 / E to J Application of GMP on medicinal gases (manufacture of
medicinal gases) in Japan
Harmonize with the EU the regulation for GMP on medicinal gases in Japan<Background>
Medicinal gases are drugs or medicinal devices and have to be compliant withgovernmental regulations. Main regulations are national Pharmacopeia, GMP(Good Manufacturing Practices), and GDP (Good Delivery Practices).
Annex 6 describes GMP and GDP for medical gases: production and distribution.
The currently loose interpretation of GMP in Japan along with relatively low
standards of Japanese Pharmacopeia suggest, that Japanese authorities will most
likely propose a new regulations on Medical gases based on a more strict
application of GMP so as to improve safety in this domain.
Further harmonization of GMP interpretation for medical gases with European
Countries would be a good way to improve this situation and create a realdifferentiation between industrial and medical gases.

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Animal Health
WP-B / # 23 / E to J Shortening review times for animal health products
Shorten review times for new product applications<Background>
In Japan, marketing authorization of a veterinary medicinal product is granted by
the Ministry of Agriculture, Forestry and Fisheries (MAFF). For an animal drug
intended for use in food-producing animals, the Food Safety Commission (FSC)
and the Ministry of Health, Labour and Welfare (MHLW) are also involved inestablishing the acceptable daily intake and maximum residue limit, respectively.
The review process, involving three different authorities, is rather complex andcertainly has some room for efficiency improvement. Also, the review can takeextremely long time to be completed, delaying so the access of animal owners andanimals to innovative animal health products.

WP-B / # 24 / E to J Implementation of the Veterinary International Cooperation
on Harmonization of Technical Requirement (VICH)
No dual standards<Background>
VICH in its charter mandates that the VICH guidelines replace corresponding
regional requirements once they are adopted. While global companies comply with
VICH guidelines, JMAFF continues to maintain obsolete local guidelines forregistration of domestic products creating dual standards. A substantial number of
additional new studies have to be conducted in order to meet Japan’s uniqueregulatory requirements.

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Recommendations from Japanese industry
Foods
WP-B / # 25 / J to EJ Promote people’s understanding of GMO’s based on
scientific knowledge by both the governments and the private sectors
To fulfil people’s acceptance of GMO’s, governments and private sectors should
cooperate in educating people about the efficiency and safety of GMO’s based on
scientific knowledge, considering world food supply and demand prospects.
<Background>
Stable supply of food is an urgent requirement. In the mid and long term, while world
population keeps growing, there is a limit to cover the supply only by enhancing
conventional breeding on existing
farmland. Considering this situation, theintroduction and utilization of GMO should be regarded as an urgent matter. People’s
understanding is indispensible for market acceptance. Both governments and private
sectors need to educate their people based on the scientific knowledge to eliminate
these concerns.

Healthcare
WP-B / # 26 / J to E Shorten the approval time to register new micro-organism
and introduce new technology for producing seasonings and amino acids
Shortening the approval time needed for registration of new materials andintroduction of new technologies which aim for product expansion, cost reduction,
environmental concerns or diversification of the fermentation material. Clarification of
the approval process is also requested.
<Background>
The long term process for approving a set of safety evaluation such as the bacteria
manufacturing process, test products and co-products, delays the enhancement of
production and consequently, competitiveness in the EU market. The slow approval
process makes companies hesitate to invest in the EU market. On the other hand, italso weakens the export competitiveness of EU companies. For information: US
companies are introducing new technologies aggressively .

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General Issues
WP-B / # 27 / J to J Formulation and steady implementation of action plans forrealization of “Japan’s New Growth Strategies”
Formulate concrete action plans for realization of “Japan’s New Growth Strategies”
focusing on LS & BT fields as well as a new strategy for promotion of R&D and faster
applications in LS & BT.

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