Position Papers and Statements
Here you can find BIO Deutschland's position papers and statements to political issues
- German Platform on White Biotechnology: White Biotechnology - the Success Story Continues
- Statement by BIO Deutschland on the Draft Law on Genetic Testing of Human Beings (Genetic Diagnostics Law) of 30 June 2008
- Position Paper by BIO Deutschland on Regenerative Medicine and Stem Cell Research
- Statement on the German Federal Government’s Draft Law of 7 December 2007 on the Limitation of Risks Related to Financial Investments (Risk Limitation Law) Bundestag Publication No. 16/7438
- Statement by BIO Deutschland on the Protection of Intellectual Property in Biotechnology
- Statement on the Draft Amendment of the Genetic Engineering Law
- Statement on the Draft Law on the Modernisation of Conditions for Capital Investments
- Conditions for the Development of the Biotechnology Industry in Germany Position Paper by the Working Group on Finance and Taxation
- Against the Targeted Prevention of the Use of Genetically Engineered Drugs Statement on the Law on the Promotion of Competition in Public Health Insurance
- Regenerative Medicine and Stem Cell Research
- Position Paper on the Draft Law on Genetic Testing and the Implementation of this Law Working Group on Regulatory Affairs and Health Policies
- Biased Discussion on Health Costs is Harmful to Germany as a Location for Biotechnology and Pharmaceutics Working Group on Regulatory Affairs and Health Policies
- Faster Availability of Innovative Drugs via Better Cooperation with Licensing Authorities Working Group on Regulatory Affairs and Health Policies
German Platform on White Biotechnology: White Biotechnology - the Success Story Continues
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
Statement by BIO Deutschland on the Draft Law on Genetic Testing of Human Beings (Genetic Diagnostics Law) of 30 June 2008
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.
Position Paper by BIO Deutschland on Regenerative Medicine and Stem Cell Research
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.
Statement on the German Federal Government’s Draft Law of 7 December 2007 on the Limitation of Risks Related to Financial Investments (Risk Limitation Law) Bundestag Publication No. 16/7438
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.
Statement by BIO Deutschland on the Protection of Intellectual Property in Biotechnology
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.
Statement on the Draft Amendment of the Genetic Engineering Law
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%.
Statement on the Draft Law on the Modernisation of Conditions for Capital Investments
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.
Conditions for the Development of the Biotechnology Industry in Germany Position Paper by the Working Group on Finance and Taxation
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%).
Against the Targeted Prevention of the Use of Genetically Engineered Drugs Statement on the Law on the Promotion of Competition in Public Health Insurance
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 and Stem Cell Research
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.
Position Paper on the Draft Law on Genetic Testing and the Implementation of this Law Working Group on Regulatory Affairs and Health Policies
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.)
Biased Discussion on Health Costs is Harmful to Germany as a Location for Biotechnology and Pharmaceutics Working Group on Regulatory Affairs and Health Policies
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.
Faster Availability of Innovative Drugs via Better Cooperation with Licensing Authorities Working Group on Regulatory Affairs and Health Policies
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.