BIO Deutschland agrees with the appraisal of the European Commission. A one-time submission via a joint 'EU portal' would in fact be welcomed. Such a procedure would bring about a significant relief in the administrative sector, especially with multinational clinical trials, as well as greatly reduced costs for the sponsors.

Sufficient financial resources and manpower would have to be made available to the European Medicines Agency for such a procedure, in order to ensure adequate IT infrastructure for the submission of applications and the relevant documentation as well as the distribution to the Member States concerned.

In addition, such a strong harmonising of data and applications for documentation can be made possible. Moreover it could have a supporting effect when dealing with additional national requirements of individual Member States, if necessary. The Member States should therefore be encouraged to reduce administrative requirements and to remove country-specific requirements from their respective federal legislature, which do not contribute to a greater security and strengthening of the rights of the participants of clinical trials, and to adapt legislature accordingly.

The portal would allow an application to be submitted that is suitable to be reviewed by the proper national authorities and the respective ethics commissions. All applications would be submitted via the portal. It does not matter whether the clinical trial is conducted in only one Member State or several Member States. This would be excellent support for the expansion of the clinical development programme as well as for the inclusion of additional Member States.

The central validation of applications would ensure that standardized requirements would be introduced and published, which would lead to an improvement of a successful submission quote of applications ("first-time-right"). This would especially simplify matters for small and medium-sized companies and is therefore quite welcomed.

When submitting follow-up applications, being able to refer to information that has already been submitted via the EU portal would make managing the dossiers for investigational products much easier. Other sponsors could refer to information already submitted on the basis of a written agreement and additional Member States could be included in the clinical development at a later time.

The use of a reference language (in this case English) would reduce administrative costs for all submissions considerably. The protocol, in the form of a synoptic overview, the form for the written permission of patients after prior clarification, the information sheet for patients as well as specific documents for the respective ethics commission could be translated into the language of the country, in which the clinical trial is to be carried out and also be submitted as country-specific, supplementary documents via the EU portal.

The submitting of applications via a joint EU portal should at the same time bring about the distribution of information and the reviewing of applications for approval in all Member States involved. A review by the proper national authorities and ethics commissions would run parallel. In addition, the use of a standard portal would allow a speedy recheck and approval of the clinical trial, as, for example, the case already is in Germany.

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The development of new therapies (like tissue engineered products and somatic cell - or gene therapy medicinal products) is positively evaluated everywhere and cited as a good example for high tech place Germany. Already the application of cellular therapeutical products leads to an improvement of patients’ treatment with certain diseases which have not be treated appropriately so far. Promising new approaches are developing. The new legislation EG 1394/2007 about advanced therapy medicinal products (ATMP) entered into force as from December 30, 2008, determining specific rules for registration and surveillance of medicinal products for new therapies.

The association of biotechnology industry in Germany, BIO Deutschland, explicitly welcomes the ATMP legislation as a clear legal framework for these products. However the new regulation is partly inhibiting innovation, especially for small and medium enterprises (SMEs).

The new legislation demands an obligatory time and cost intensive centralised European authorization procedure. The given transition period to get the central registration approved for companies having already products in the market (some products have been in the market already for years) is so short that in the time given the requested demands cannot be implemented. As a consequence the companies concerned have to take off their products from the market. Sales breakdown has to be expected which especially cannot be compensated by researching SMEs. Most of these companies only have one or a small number of products in the market so that they cannot compensate their originating costs by other projects like in big industry. Furthermore the products having been reimbursed by health insurance so far now have to be delivered at no charge as testing compounds for clinical studies. The cost per testing compound can be in the range of several thousand Euros and SMEs might not afford this without risking the existence of the company.

Already in 2007, with the “tissue law” coming into force (German law about quality and safety of human tissue and cells) converting the EU guideline 2004/23/EG into national law SMEs were stressed by additional bureaucratic efforts inhibiting the development of innovative therapies.

Due to the number of interacting rules and the diversified interpretation by different German federal state authorities the situation is quite diffuse. Tissue or cell sampling being feasible in one federal state might be impossible under the same conditions in another.

Therefore BIO Deutschland claims:

1. To leave registered ATMPs being in the market as long for distribution as it takes to decide about the central registration procedure, if the application for registration had been filed to EMA before the transition period.
2. The support of clinical studies for ATMPs being on the market by compensation of costs for the testing compounds, which were reimbursed by health insurances so far.
3. Provide consistent and uniform rules concerning the “Entnahmestellen” in every federal state.

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The Innovative Medicines Joint Technology Initiative (IMI) was launched in May 2007. From the beginning, significant stakeholder groups have expressed concerns about IMI’s intellectual property rights policy and its funding model. These concerns have been repeated on several occasions and have been transmitted to the IMI Member States Group, the IMI Joint Undertaking (JU) Governing Board and the European Commission.

The IMI JU is currently reviewing its intellectual property policy and the funding rules for reimbursement of indirect costs. A group of IMI stakeholders has decided to publish this joint statement to provide useful input in this review process and ensure that long-standing concerns from all key stakeholders are addressed.

The IMI JU has already launched two calls for proposals and is preparing a third call. Participation in the first two calls has been well below potential, because many organisations – SMEs, research organisations and universities – have not participated fully as a result of concerns regarding the complex and potentially un-balanced IMI IP policy and unattractive funding model. The programme is unlikely to achieve its objectives if participation remains sub-optimal.

Stakeholders wish to see IMI’s IP policy revised in order to provide for:

• reasonable definition of research use and of access rights for third parties;
• less extensive access rights for participants and affiliated entities worldwide, or at least better control of access rights by the owner;
• fair conditions for access (time limit, request in writing, fair and reasonable terms rather than royalty free);
• and more balanced and reasonable conditions  for licensing, assignment and other disposal of own assets, following the FP7 model (II.26.3 IMI GA).

These central issues have also been identified by the IMI IP Working Group but a resolution is still pending.

With the deadline for the third call rapidly approaching, it is crucial that real improvements are introduced as a matter of urgency.

The IMI funding model needs to be sufficiently competitive to attract the best players and to allow SMEs to engage effectively in large numbers. The recent report by the JTIs’ Sherpa Group [1] recognises stakeholder concerns and points the way forward. It recommends that “funding rates [...] should be set at levels comparable to those of the Framework Programme”[2]. The Sherpa Group has also recommended that “JTIs should implement measures to more effectively engage the SME community”[3].

IMI funding rules should be modelled on FP7 funding rules and the starting point for calculating funding rates should be coverage of the full costs of research. The current 20% cap on the reimbursement of indirect research costs ignores economic reality and must be lifted as a matter of urgency.

The undersigned stakeholder organisations believe that the necessary reforms must be implemented in time for the third IMI call for proposals. This is essential if IMI is to achieve its objectives of fostering long-lasting and fruitful collaborations between research organisations, SMEs, universities and pharmaceutical companies[4] and if we are serious about creating biomedical R&D leadership in Europe to benefit patients and society[5].   

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BIO Deutschland demands greater inclusion of the interests of innovative small and medium-sized biotechnology enterprises in the revision of the Medication Law. In a statement issued for the hearing of associations at the German Federal Ministry of Health, the biotech industry association made it clear that the motivation for investments in medical advances and the planning security necessary for the safeguarding of companies must be guaranteed for researching companies that develop new agents and treatments for patients.

Peter Heinrich, Chairman of the Board of BIO Deutschland, commented, "Some of the planned amendments, particularly those concerning treatment with unauthorised drugs in extreme cases, must be regarded critically." He added that short-term and disadvantageous amendments to operating conditions would more often and more rapidly lead to the risk of mainly small and medium-sized medication manufacturers and therapy providers facing bankruptcy than would be good for Germany as a business location. In his concluding remarks, Peter Heinrich stressed, "Small and medium-sized biotechnology companies in particular are not only an important element in the value-added chain in medicine but are also a source of new business models, products and processes. Above all, they make an above-average contribution to the creation of jobs and the increase of expenditure on research and development."

Michael Pehl, Chairman of BIO Deutschland’s Working Group on Health Policy, welcomed the use of current European regulations by the German Federal Ministry of Health in the adaptation of the Medication Law. However, he was also very disappointed that the opportunity to tackle urgently needed improvements in the conditions for clinical studies had been missed.

Commenting on the same topic, Markus Hofbauer, Chairman of BIO Deutschland’s Working Group on Regulatory Affairs, said, "To a certain extent, the procedure for the authorisation of clinical studies in Germany is unnecessarily complicated and time-consuming. By making some amendments to the existing regulations, the bureaucratic process could be significantly simplified without putting control over the studies or the safety of patients at risk. At the same time, the procedure could be aligned with European standards, thus significantly improving the competitiveness of Germany as a location for clinical studies."

The draft law will now be amended and passed in this legislative period. The Working Group on Health Policy will meet in Martinsried near Munich on 16 February to discuss details that may be of relevance to the parliamentary debate.

BIO Deutschland attended a reading of the Genetic Diagnostics Draft Law at a meeting of the Standing Committee on Health at the Bundestag (Lower House of the German Parliament). During the meeting, BIO Deutschland demanded that urgent improvements be made to the government’s draft. Peter Heinrich, Chairman of the Board of BIO Deutschland, stressed that the draft was neither in the interests of citizens, nor did it take into account the current state of scientific research. He added, "The government must face the challenge of finding a more future-oriented and practical solution that is in the interests of Germany-based consumers and innovative companies."

However, the association also issued a statement in which it welcomed the government’s initiative to lay the foundations for a framework for genetic testing in Germany and to prevent discrimination resulting from genetic characteristics in the terms of this draft law. Nevertheless, the wide range of issues and information that are involved in the broader topic of genetic testing demand that there be not only a more detailed approach to those procedures that to date may only be carried out by a fully-qualified doctor, but also that there be a knowledge-based differentiation between diagnostic and predictive testing, as pointed out by Erwin Soutschek, the Chairman of BIO Deutschland’s Working Group on Diagnostics.

There are currently two aspects that now make it impossible to differentiate reliably between diagnostic genetic testing and predictive genetic testing. Firstly, there is now improved scientific knowledge about the connection between an inherited predisposition and the onset of a disease. Secondly, constantly refined diagnostic methods allow diseases to be diagnosed at increasingly early stages.

Further to the first aspect, there are very few incurable diseases that will occur with absolute certainty during a person’s lifetime as a result of an altered gene. Huntington’s disease is the best-known example of an illness that is caused by an inherited factor. In younger people, the disease initially leads to coordination problems and psychiatric changes; over the course of a few years, it causes dementia, insanity, paralysis, and leads to death. In the past, this rare and feared disease often served as a model for considerations and discussions about predictive genetic testing. New research has shown that in the case of most other genetic disorders, the onset can only be predicted with a certain probability. Early knowledge about a person’s predisposition may even allow the onset of the disease to be largely prevented. Examples include the metabolic diseases, phenylketonuria and maple syrup urine disease (branched-chain ketoaciduria). In addition, most common disorders also have a genetic component that contributes to the onset of the disease along with environmental factors and the patient’s lifestyle. Widespread conditions such as diabetes and cardiac disease are examples of this.

As regards the second aspect of the difficulty of distinguishing between diagnostic and predictive genetic testing, the boundaries between health and illness have also become increasingly blurred as a result of medical progress and ever more sensitive diagnostic methods. Many diagnostic markers used in the early detection of a disease are direct gene products that are included in the framework of the draft law. Even known experts have heated debates about whether a gene product is an indication ("predicator") or a symptom of a genetic disorder. As the exact date of the onset of a disease cannot be precisely determined, the differentiation between an existing and future disease and thus the differentiation between diagnostic, genetic, and predictive genetic testing is no longer possible. Moreover, most of the classical diagnostic markers, which are not based on genetic diagnostics, are also predictive.

BIO Deutschland calls for the two following amendments, among others, to be included in the Genetic Diagnostics Law, so that it is more in the interests of citizens:

Firstly, increasing demand should be better met by the admission of further suitable (indication-based) groups of consultant doctors, who could qualify in the field of genetic diagnostics by attending training courses. There are currently only a few hundred human geneticists and doctors specialised in genetic consultation in Germany, who are not able to meet the entitlement of 80 million people to obtain qualified advice on individual medical questions.

Secondly, parentage testing and the so-called paternity test should no longer be included in the Genetic Diagnostics Law. The DNA analysis used to ascertain parentage does not aim to determine the individual’s genetic disposition. Like the blood group analysis that is still used today, this type of DNA analysis is used to determine the probability of biological parentage. The suggested regulation would imply unnecessary interference by the state without creating any improvements for those involved and can therefore be deleted without substitution.

The industry association of the German biotechnology sector, the Biotechnology Industry Organisation of Germany (BIO Deutschland), warns against tightening requirements for studies on animals, particularly to the detriment of small and medium-sized enterprises, without this leading to verifiable improvements for the animals.

As the sector association, we represent the small and medium-sized enterprises of the German biotechnology branch. The majority of our members are active in the so-called "red" (medical) biotechnology sector, that is, they develop medication. To ensure the safety of patients, tests on animals are an indispensable element of biomedical research because around 70% of all severe side effects of new drugs can only be ascertained by such experiments. Most of these tests are stipulated by the drugs licensing authorities. We lobby for studies on animals to be conducted only when they are legally stipulated or essential for other reasons, when there are no other options and the burden on the animals is kept as low as possible. We wish to issue the following statement on the Draft Directive by the European Parliament and the European Commission on the Protection of Animals Used for Scientific Purposes, which has been submitted to the German Federal Ministry for Education and Research.

• In Article 35 of the EU Directive on the Protection of Animals Used for Scientific Purposes, a differentiated wording in the form of approval caveats and disclosure obligations in accordance with the valid German regulations (Section V of the German Animal Welfare Act) is vital.
• In Article 35 of the EU Directive, authorisation should be granted to "tests on animals" or "procedures" rather than to "projects" in terms of Article 3, Clause 1 of the EU Directive on the Protection of Animals Used for Scientific Purposes. As experiments are part of (entire) projects, and the authorisation in question only concerns these experiments, the use of the term "project" is misleading.
• Accrediting staff involved in animal experiments for a limited time period only, as stipulated by Article 20, Clause 3 of the EU Directive on the Protection of Animals Used for Scientific Purposes, creates unnecessary bureaucracy and costs. As staff have to prove that they are qualified in their initial accreditation procedure or when there are changes in personnel, this type of regulation, particularly as concerns innovative small and medium-sized enterprises, must be rejected.
• Article 24, Clause 2 of the EU Directive on the Protection of Animals Used for Scientific Purposes, must be extended to other professionally qualified individuals. Doctors and biologists (from the field of zoology) with specialist knowledge are also suited to undertaking the position of an animal welfare officer.
• Small and medium-sized enterprises are particularly harshly affected by the regulation on an ethics commission in companies (Article 25 of the EU Directive on the Protection of Animals Used for Scientific Purposes) and the double burden this places on employees. This regulation would lead to a higher workload and to increased bureaucracy, which is not necessary for animal welfare, especially when viewed in the light of the detailed examination of the ethical aspects carried out during the experiment authorisation procedure.

Highly pathogenic micro-organisms and the metabolic poisons they produce are of great interest to scientific research in the fields of infections, immunity and pathogenicity factors.
However, work and research with these types of pathogenicity factors also leads to the danger of the dual application of results (the so-called "dual-use dilemma"). Results can be used not only for scientific advances but also equally in the manufacture of biological weapons. The dual-use dilemma describes the conflict between the protection and safety of the population and freedom to research and publish.

The Biotechnology Industry Organisation Deutschland (BIO Deutschland) supports the code of conduct drafted by the German Research Foundation, "Working with Highly Pathogenic Micro-Organisms and Toxins". In many points, the demands made by the German Research Foundation can be accepted exactly as they stand.
The maintenance of conduct guidelines for work with these types of pathogenicity factors is necessary.

Germany is a worldwide heavyweight in the field of white biotechnology. Expertise, the quality of scientific and technical establishments, and the capacity and performance of manufacturing plants mean that Germany is No. 1 in Europe. Worldwide, Germany shares the top position with the USA. The position paper describes some representative contributions made by industrial biotechnology to climate protection and sustainability and uses many different examples to illustrate the variety of the fields of application of this technology

The German Biotechnology Industry Organisation (BIO Deutschland) welcomes the Federal Ministry of Health’s draft law on genetic testing of human beings (the Genetic Diagnostics Law) of 30 June 2008, which will provide the basis for a framework for genetic testing in Germany and prevent disadvantages resulting from genetic characteristics. However, the range of problems, inter-related issues and information that are involved in genetic testing make it necessary to proceed in a more precise way than is foreseen in the current draft law. By no means may the state, which in this legislation expressly declares its aim to respect and protect human dignity and the right to information-based self-determination, be allowed to use loopholes to make personal decisions for the individual and cause conflicts in the private sphere. This also applies particularly where new technologies and possibilities are concerned. As a result of the rapid development of science and industry in biotechnology in general and genetic diagnostics in particular, one is faced with medical challenges in previously unknown dimensions, but also with the possibility to fulfil people’s need for safe personal information about their genetic make-up. If no better solution is found here, this need – in spite of the legislators’ best intentions concerning consumer and data protection and quality assurance – will be met by foreign markets. This harms German companies.

The sector association, BIO Deutschland, therefore demands the following in order to achieve a feasible and citizen-friendly Genetic Diagnostics Law:

• The differentiation between genetic testing for personal and medical purposes: Genetic analyses that concern the body and health are not automatically genetic analyses for medical purposes. Every individual should have the freedom to commission genetic tests for personal reasons, such as the planning of his or her lifestyle, in qualified laboratories and on his or her own authority.
• A more liberal allowance in the number and type of doctors authorised to carry out genetic testing in order to avoid patients being faced with a shortage of doctors: Currently, only a few hundred doctors specialising in genetic consultation are supposed to meet the right of 80 million people in Germany to qualified advice on individual medical problems. The authorisation of further suitable consultants such as gynaecologists and oncologists would help to meet the increasing demand.
• The integration of legislation on genetic tests used to clarify parentage in a context other than the Genetic Diagnostics Law: Neither the DNA analysis used to prove parentage nor the blood group analyses still used today to determine the probability of biological parentage concern the determination of individual genetic make-up,. Legal parents must be given the freedom to carry out a safe and discreet clarification of parentage in Germany while maintaining good family relations. The draft law’s current suggested regulation implies unnecessary interference by the state and does not provide any improvement to those involved – it can therefore be deleted.

According to the current German cut-off date regulation in the Stem Cell Law, it is only possible to work in Germany with embryonic stem cell lines that have been found to be contaminated. A redrafting of the Stem Cell Law and the adjustment of the cut-off date regulation therefore appear to be urgently required, if one wants to avoid German research and development teams in biotechnology companies and academic institutes finding themselves at an impasse in the foreseeable future, with their internationally excellent position in the field of regenerative medicine at risk and in danger of ending up being excluded from a promising future technology. As stem cell research is a highly innovative sector, the constantly newly generated research results must be continually re-evaluated. Accordingly, legislation must also be constantly critically reconsidered in order to be able to make any necessary adjustments in a flexible way. At any rate, the current valid legal parameters must not be allowed to block discussions on possible further developments of this legislation.

In order to halt the deterioration of research conditions that has come about since the introduction of the Stem Cell Law and to recreate the law’s original aim and stop the existing risk of punishment facing German scientists working in international projects, BIO Deutschland advocates the following:

• Moving the cut-off date (for example to 1 May 2007).
• Removing the threat of punishment of German scientists, that is, an unequivocal application of the Stem Cell Law to Germany only.
• Reduction of bureaucratic barriers in the official licensing procedures in the area of stem cell research.

Although strict control of research in this field is necessary, bureaucratic obstacles involved in an application should be minimised. The suggested regulations on cost for embryonic stem cell research also seem to be very complicated and are not transparent enough.

The industry association of the German biotechnology sector, the Biotechnology Industry Organisation of Germany (BIO Deutschland) accepts that that Law on the Limitation of Risks Related to Financial Investments should make financial investments in companies in Germany more transparent and thus better protect entrepreneurs, their staff and investors from economic risks. However, BIO Deutschland is concerned that unclear wording in the law will aggravate the investment climate in Germany.

Small and medium-sized enterprises in new, innovative sectors generally do not have access to outside capital because of the inherent risk involved in their type of business. As a result, they primarily finance the necessary research, product development and company growth with equity capital, which is provided by financially strong individuals (business angels) or venture capital companies or in the case of listed companies by institutional and private investors. The money required for investments is usually procured over a period of several financial stages, with gaps of 24 to 30 months between them. Regular contact between stockholders and shareholders and changes to the stockholder structure are therefore part of the company’s day-to-day activities and are vital components in the successful development of the company. The newer the company is, the more likely it is that several stockholders will own larger equity capital shares in the company. Some venture capital companies only work with a new, innovative company when they can control an investment share of around 20 per cent. Moreover, even after a company has been listed, private venture capital (PIPE, Private Investment in Public Entities) will be needed several times in order to finance growth.

As a result of the high degree of specialisation and the limited number of investors, entrepreneurs from the biotechnology sector and their investors represent a relatively small group in Germany.

• Legal certainty for investors must be guaranteed by clear wording and increased financial risk must be avoided.
• An increase in bureaucratic procedures is justified in order to achieve greater and internationally resilient transparency.

The protection of intellectual property is of great importance to companies worldwide. The trade association of the German biotechnology sector, the Biotechnology Industry Organisation of Germany (BIO Deutschland), welcomes the German Federal Government’s recognition of this in its Draft Law on the Improvement of the Enforcement of Intellectual Property Rights . However, the association calls for the amendment of German legislation in order to take into account the needs of small and medium-sized innovative enterprises because “(in research) the necessary investments are particularly high and risky in the area of genetic engineering and can only be financially viable with appropriate legal protection. […] Biotechnology and genetic engineering play an increasingly important role in the various industrial sectors and the protection of biotechnological inventions is of vital importance.”

Inventions by small and medium-sized enterprises create the basis for high-quality jobs and for the future viability of the economy. This is the reason why small and medium-sized enterprises, for instance in the USA, are granted financial benefits for the protection of intellectual property as opposed to their larger, established competitors (“Small Entity Status”). This has an impact beyond the borders of the USA because it is significantly more difficult for innovative technological companies in Germany and Europe to compete than it is for their US competitors.

BIO Deutschland is therefore actively seeking the improvement of conditions for the protection of intellectual property for innovative small and medium-sized enterprises in Germany and Europe and demands the following:

• Intellectual property: a 50 percent reduction of the European fees for filling an application, assessment and issuing as well as the national fees, especially the annual fees, for SMEs, universities and independent inventors.
• Effective and standardised legal protection in all member states of the European Union (EU) through an unlimited implementation of the EU regulations (the European Parliament¡¦s and European Council¡¦s Regulation 98/44/EG on the legal protection of biotechnological inventions) and the resolution by the Administrative Council of the European Patent Office of 16 June 1999.
• The introduction of a regulation on a period of grace for all types of filling applications, which, in the face of the existing pressure in the sector to publish scientific findings rapidly, would reduce the risk to employers, their staff and investors of advance publications on an invention before its application filling.
• An amendment of the Law on Staff Inventions, which would ensure that inventions made in a company would be the legal property of the company; the bureaucratic effort involved in the implementation of the law should be reduced, without limiting the compensation entitlement of an inventor employed by a company.
• In the case of bankruptcy, there should be no obstacles resulting from a right of first refusal of an inventor employed by a company (¡± 27 EStG) in a sale of intellectual property.

The current draft of a Fourth Law on the Amendment of the Genetic Engineering Law and the draft of a regulation on good professional practice in the cultivation of genetically modified plants (Regulation on Genetic Engineering in Plant Cultivation) fail to achieve both the purpose of the law as well as the government’s aim. The latter envisages that “research and the use of genetic engineering be promoted in Germany”. A de facto ban on the use of innovative technology in Germany, which could make a valuable contribution to securing the future of our country, is concealed by the phrases “freedom of choice” and “coexistence”.
The economic association of the biotechnology branch, the Biotechnology Industry Organisation of Germany (BIO Deutschland) therefore demands the following in the forthcoming amendment:

• Adaptation of the entitlement and liability regulations in order to increase legal certainty for all users, companies, farmers and third parties such as beekeepers.
• Protection of farmers and researchers from criminal acts by keeping the location of fields of plants cultivated by biotechnological methods confidential and making this location known only to enquirers with a proven justified interest.
• Extension of the concept of “disposal” to take into account the designated use of the harvest in following official orders to break up fields or destroy crops.
• The complete or partial removal of work with genetically modified organisms that are not micro-organisms and are safe for human health and the environment, such as moss, from the regulations of this law.

In addition, BIO Deutschland asks for support from politicians when the economy in Brussels is urging the design of a positive list of safe micro-organisms, in order to avoid unnecessary bureaucracy and costs in the industrial biotechnology sector in the member states.

BIO Deutschland demands the following for the regulation on good professional practice in the cultivation of genetically modified plants:

• That private arrangements between neighbours not only be permitted but that these agreements be left in the private sphere in order to keep the bureaucracy and costs for the cultivation of genetically modified plants at a financially viable level.
• That the distance between cornfields be set at a maximum of 150 metres and that it is arranged that this distance be regularly amended in accordance with the latest scientific research findings

The regulation of 150 metres was already made in order to safely attain a level of significantly less than the threshold value of 0.9% in the cross-pollination with neighbouring fields. BIO Deutschland strongly rejects the arbitrary doubling of the 150-metre distance between GM and conventional fields to 300 metres for organically farmed fields. This makes no scientific sense. Moreover, the threshold value of 0.9% also applies to organically cultivated crops. This threshold value alone, and not the subjective commercial interests of organic farmers, is relevant for the conduct obligations of GM farmers. 150 metres are more than sufficient to maintain the threshold value of 0.9%.

The industry association of the German biotechnology sector, the Biotechnology Industry Organisation of Germany (BIO Deutschland), recognises several positive approaches to the competitive disadvantages correctly analysed by the German Federal Government in the current Draft Law on the Modernisation of Conditions for Capital Investments. However, important concerns held by BIO Deutschland still have not been taken into account. The current draft law misses the target and as a result, Germany will fall further behind in the competition to provide attractive conditions for research and development. With the lack of venture capital in Germany, as well as its transference from the country, there is also a threat of a decline in technological performance ability and innovative strength.

BIO Deutschland appreciates the German Federal Government’s offer “to evaluate the law on the basis of its aims two years after it comes into effect”, which was made in the counterstatement to the statement by the Bundesrat. In the association’s opinion, there is thus the chance that the intentions of the law might gradually deflect the negative results of the Corporate Tax Reform, at least for some of the innovative small and medium-sized enterprises, especially if the following improvements can be made:

• Innovative small and medium-sized enterprises must be allowed unlimited use of the deficits carried forward from research expenditure.
• The minimum fragmentation limit must be abolished so that private investors can spread out their venture capital.
• Capital gains from investments in small, innovative companies must remain exempt from taxation in spite of the Corporate Tax Reform.
• The conditions for innovative small and medium-sized enterprises must continue to be systematically improved by targeted tax incentives for research in the private sector.

BIO Deutschland is not seeking the creation of further exceptions in these necessary amendments. This would be contrary to the further aim of a tax simplification. However, the completion or further development of the tax law is vital because it is of great significance to the strengthening of the Federal Republic of Germany as an internationally competitive location for research and development.

It is regrettable that none of the bills of this legislative period so far have provided the so urgently needed step towards targeted incentives for research and development.

The concerns of the Federal Ministry of Finance that tax revenue will decrease as a result of improved conditions for innovative small and medium-sized enterprises are not justified. Analyses from France show that the drop in tax revenue is more than compensated for in less than two years by increased revenue, investments and job creation.

Biotechnology is one of the most important key technologies and promoters of innovation for this century and is one of the sectors that form the basis for a sustainable economic upturn. With growth rates of 15 – 20 percent worldwide, it is one of the largest growth engines for both the labour and the capital market. Innovative biotech agents already account for 27 percent of worldwide medication research and 10 percent of the worldwide medication turnover.

The state offers a wide range of research funding. However, organisational streamlining and bureaucratic simplification would be welcome. ERP umbrella funds and high-tech start-up funds provide a positive approach. However, because of the necessary volumes, public funding can only cover the basic research, early start-up phase and, in some cases, individual projects.

In order to strengthen the sector in the long term, a capital flow that goes beyond setting up companies must be made easier. The market can gain strength from the inside out by targeted relief for companies and investors. Subsidies could thus increasingly fade into the background. It is important that the particular needs of this new sector be taken into account. Competitive disadvantages within Europe must be abolished so that the biotechnology sector in Germany can survive and flourish. Therefore, the main aim must be to support the willingness to invest and to take risks on the part of financially strong investors from Germany and abroad, as well as innovative companies, by improving conditions in the following areas:

• Improvement of conditions for the capital market
• Improvement of taxation and corporate law conditions

Above all, the focus must be on the targeted elimination of weaknesses in the financeability of biotechnology. Corporate risk-taking should be encouraged rather than penalised. This applies to both small and medium-sized enterprises and to public companies, insofar as the companies are subject to a need for subsequent funding because of the development costs of future, innovative products, without which they face a threat to their survival. All parties who face this business risk in this key industry, that is, investors, companies and staff, should sense this support in Germany.

For this reason, we demand that the following initial measures be implemented with immediate effect:

• The possibility to offset losses resulting from investments in fiscally transparent partnership funds or direct investment in research-intensive biotechnology companies. An appendix or a clarification of § 15 b EStG would be necessary as this law cannot be applied to the aforementioned funds or to investments in innovative companies.
• Special amortisation or other tax benefits for the purchase of shares in innovative companies, including listed companies, similar to the British AIM.
• Relief in the exclusion of subscription rights for listed companies (limit of 20%).

The Grand Coalition’s Law on the Promotion of Competition in Public Health Insurance contains many anti-innovation regulations that will further prevent the development of the German biotechnology sector. This law is in marked contrast to the “High-Tech Strategy for Germany”, which was only recently launched by the Federal Ministry of Education and Research. Drugs developed by genetic engineering and manufactured by biotechnological methods will face further obstacles, which will lead to a targeted restriction in their prescription by doctors.

BIO Deutschland opposes additional and specific restrictions in the prescription of highly innovative drugs. Genetically engineered drugs are distinguished by the fact that they can tackle the course of an illness in a far more targeted way and are mostly similar or even identical to the body’s own molecules. As a result, genetically engineered drugs are usually far less likely than conventional drugs to cause side effects.

BIO Deutschland is in favour of the promotion of highly innovative drugs as they can improve the treatment of many very serious diseases, which leads to better cure rates and a shorter duration of illnesses, and thus to a possible cost saving. However, the current draft law would cause the exact opposite of this and lead to higher costs in the medium term, as well as to further health reforms that have not been thought through.

Regenerative medicine is a new field of medical research whose aim is to use innovative medical technologies to cure, or to partially or completely “reconstruct”, diseased or injured cells, tissues or organs, or to support the body’s own cures. Stem cells are regarded as a source of hope in regenerative medicine. Although stem cell research is still at an early stage worldwide, the medical potential of these cells in the treatment of many diseases that currently cannot be adequately treated is very highly regarded by the international research community.

In order to improve conditions for conducting this research, BIO Deutschland’s position paper makes demands on the following points:

• Ensuring research freedom within ethical and moral guidelines.
• Using an open minded public dialogue to inform the public on the uses and risks of genetic research.
• Targeted public financing of stem cell research.
• The research focus to be on work with adult stem cells.
• Improving the conditions for innovation in research by the adjustment of the regulation on the deadline for research on embryonic stem cells.
• Reducing bureaucratic barriers in the official authorisation procedures in the field of stem cell research.

Companies that offer applied human genetics services and products are among those represented by BIO Deutschland. These services include forensic DNA analysis, paternity tests, and the analysis of molecular biomarkers such as genetic polymorphism (SNPs) used in applications in pharmacogenetics and preventive medicine (individualised medicine). The fundamental values and aims of these companies will be presented in the position paper and a statement on the Draft Law on Genetic Testing from the point of view of DNA analytics will be given.

The following application areas are involved:

• Genetic analyses used in prognostic and predictive medicine
• Forensic genetic analyses
• Genetic analyses used in parentage determination

The biotechnology companies active in these areas offer their services on a commercial basis, which are subject to established quality criteria and deadlines. These services are also provided by publicly financed institutions such as (forensic) medical university laboratories and the laboratories in the State Bureaux of Investigation. Some specialist medical laboratories and (hospital) doctors claim an exclusive right to conduct these analyses.

Bio Deutschland’s key demands are as follows:

• Genetic tests for potential diseases that have a significant impact on health, as well as antenatal tests, should only be available from a doctor.
• Companies should be allowed to offer the genetic tests used to ascertain the risk of preventable diseases and for so-called lifestyle areas such as sporting performance and the tendency to obesity freely on the private market.
• Laboratories must be licensed to conduct genetic tests.
• The laboratory must be managed by a doctor or scientist with extensive experience in molecular biological analytics.
• Genetic analysis in forensic medicine should increasingly be devolved to commercial companies that have a proven qualification comparable to that of police laboratories.
• Genetic tests used for the determination of parentage (paternity tests) should be allowed to be commissioned without the consent of all parties involved in order to protect the existing family relationships and to prevent additional court or administrative costs. (Please see inter alia the Baden-Württemberg Bundesrat initiative.)

As far as potential savings in the health sector are concerned, drugs are usually mainly mentioned as a worthwhile aim by both politicians and the public. Therefore, it is not surprising that the pharmaceutical industry – and hence the biotechnology companies as well – were particularly affected by the last healthcare reform, even if this is perceived differently by the public. Taking the manufacturers’ discounts into account, the turnover of prescribed drugs charged to the state health insurance companies in 2004 fell by 12%, which had an even more drastic impact on the profit situation. While the pharmaceutical market was able to recover as a result of the reduction of the manufacturers’ discount from 16% to 6% in 2005 (leading to negative reports in the media), the Law on the Cost Effectiveness of Prescribed Drugs was the immediate reaction to this recovery. With its renewed price moratorium and in particular its bonus-penalty regulation, this law will further weaken the pharmaceutical industry and thus the biotechnology branch too, as well as harming both Germany as a business location and – which should not be forgotten – patients.

Suggested solutions for policies that are more conducive to innovation are presented in the position paper, taking into account the actual burden on the health insurance companies’ budgets caused by the cost of drugs.

Many years still pass until innovative drugs can be made available to patients, even after they have already proved their positive risk-benefit relationship in clinical tests. BIO Deutschland supports the reduction of this timeframe by the promotion of national competence in the development and evaluation of innovative drugs and technologies. This involves the companies affiliated in the association (developmental competence), on the one hand, and the licensing authorities (evaluation competence) on the other. The association’s interlocutors are primarily the German authorities (for example, the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute), followed by the European institutions (such as the EU Commission and the EMEA). The establishment of a dialogue on mutual benefits at an early stage is of vital importance. The early involvement of the licensing authorities in new therapeutic approaches and innovative technologies should sustainably support the already apparent transformation of these authorities into modern, effective and internationally competitive institutes. Likewise, the early recognition of scientific and regulatory standards makes it possible for companies to develop drugs rapidly and cost-effectively; after this process, companies are faced with high-cost licensing applications.

Among the factors that are decisive for the success of these aims, the most important are as follows:

• Intensive cooperation on mutual benefits between the association’s member companies and the authorities.
• Facilitation of clinical research, for example by the abolition of barriers specific to Germany.
• Cost relief in authorisation applications (clinical testing, drug licensing).
• Avoiding new, additional barriers before the launch of drugs on the market.

Measures for the achievement of the above-mentioned success factors for the creation of an infrastructure that would be exemplary in Europe are suggested in the position paper.