Our Political Principles and Positions
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As part of our commitment to tackle corruption, our Corporate Policy “Code of Conduct for Responsible Lobbying” sets out binding rules for our involvement in political matters and creates transparency in our collaboration with the representatives of political institutions. We also proactively participate in existing transparency initiatives such as those established by the European institutions or the U.S. Congress.
The Group’s Public and Governmental Affairs Committee develops the principles for the alignment of Bayer’s political lobbying. This body establishes the company’s position with regard to relevant political and legislative decision-making processes, as well as advising the Board of Management on its position on important political issues. In 2018, Bayer’s global lobbying work focused on the issues of “innovation,” “access,” “reputation” and “freedom to operate.” In the area of “innovation,” Bayer advocates social discourse about good framework conditions for the development of innovative technologies, as well as strong protection of intellectual property. The issue of “access” deals with safe, fast and simple access by patients and consumers to our products. In the area of “reputation” we want to position Bayer as a leading life science company. In this context, we actively seek dialogue with various societal players, particularly nongovernmental organizations and politicians. The term “freedom to operate” summarizes all activities with which Bayer advocates strictly science-based regulation and an intensive and results-oriented debate about new technologies. The Public Affairs & Sustainability Function, in cooperation with the country companies, is responsible for the specific local implementation of lobbying work, compliance with ethical and legal criteria and the creation of transparency.
Our liaison offices in Berlin, Brussels, Washington, Moscow, Brasília and Beijing are key touchpoints between the company and political stakeholders. We publish details of costs, employee numbers and any of the other statistics required in each country in the transparency registers of the European institutions and the U.S. Congress. Bayer goes far beyond the statutory requirements in doing so. For instance, the Group also publishes data for countries such as Germany where there is no legal publication requirement. In 2019, the costs incurred at the liaison offices totaled approximately €1.7 million in Berlin, Germany; €4 million in Brussels, Belgium; €9 million in Washington, United States; €0.25 million in Moscow, Russia; €0.51 million in Brasília, Brazil; and €1.51 million in Beijing, China.
As set out in our corporate policy on responsible lobbying, we did not make any direct donations to political parties, politicians or candidates for political office in 2018. Some associations of which the Group is a member make donations on their own initiative, in compliance with statutory regulations.
In the United States, where corporate donations are prohibited by law for federal elections and in many cases also state and local elections, some employees use the Bayer Corporation Political Action Committee (BayPac) to support legislative candidates through private donations. Political action committees are state-regulated, legally independent employee groups. The private donations made by BayPac are regularly reported to the U.S. Federal Election Commission and can be viewed on its website.
Our Political Positions
Bayer engages on a number of different topics, in multiple countries, and with a variety of stakeholders and organizations. We proactively publish political position papers to ensure transparency in our collaboration with stakeholders and decision makers.
Updates to this non-exhaustive list of political positions will continuously be made available. The positions listed below provide an overview of the overarching positions of the company and therefore can be seen as guidelines for our political engagement.
Animal studies: Essential for safe medicines and crop protection agents
Animal studies are an important element in the research and development process for medicines and crop protection agents. Around 90% of the studies performed at Bayer are required by law in order to ensure that innovative active substances and products are effective and safe for people, animals and the environment. All other animal study projects, e.g. in basic research, are only permitted if no research methods that do not involve animals are available and the project fulfills all the other requirements of a clearly structured application and notification process, thus enabling the authorities to determine that the project is essential.
The similarities between humans and other mammals allow meaningful conclusions to be drawn from these studies regarding the action of investigational substances in the human body. This has enabled a large number of vaccines and medicines to be developed for the treatment of conditions such as cardiovascular diseases, cancer or the immune disorder AIDS. Toxicology studies performed in animals are also a legal requirement within the development process for crop protection agents.
The performance of such studies is regulated in detail in the corresponding legislation, and compliance with the regulations is monitored by the competent authorities. Animal welfare committees in which animal welfare associations are represented are involved in the process in an advisory capacity. In addition to national animal welfare regulations, a large number of agreements operate within the international research community to ensure uniform standards.
Yet animal studies are repeatedly the subject of controversial discussion. The research-based companies take the public’s reservations seriously and are working on an ongoing basis to develop alternative test methods in order to reduce the number of animal studies. These methods include studies using tissue samples and computer simulations. However, they can as yet only replace animal studies to a limited extent, and the authorities have approved them as a replacement for animal studies in only a limited number of areas.
Bayer performs animal studies for products for medicine and agricultural applications and is fully aware of its responsibility. The company has drawn up strict guidelines for animal welfare and animal studies and has set them out in a binding policy. Bayer also applies the 3R principle in its research activities, the aim of which is to reduce the number of animals used in studies, refine research methods and replace animal studies with alternative methods.
All our animal studies comply with the animal welfare legislation in force. Bayer’s principles on animal welfare and animal studies apply to our production facilities, partners and suppliers in countries where no special legislation exists. An internal animal welfare committee at Bayer monitors compliance with these principles.
- We provide appropriate living conditions for the animals. We also reduce the number of examinations and stressful procedures associated with interventions by using techniques such as micro-computed tomography and remote sensing measuring methods. The performance of all animal studies is additionally monitored by our animal welfare officers.
- Bayer collaborates intensively with stakeholders at national and international level to develop alternative methods in order to achieve a continuous reduction in the number of animal studies. Bayer also provides financial and other forms of support for related projects.
- In view of the fact that it often takes more than 12 years to develop and obtain marketing authorization for innovative medicines and crop protection agents, Bayer calls for predictable and reliable approval procedures that enable the company to plan within reliable time frames and to provide safe and innovative products for patients and farmers with the shortest possible delay.
- Bayer is open to an intensive dialogue with all stakeholders with the aim of jointly identifying the best solutions for animal welfare, science, patients and farmers
More information is available at:
The Future Relationship of the UK and the EU: Maximizing Economic Integration
Following the United Kingdom’s vote to leave the EU in June 2016, the task of the UK government will be to form a new (economic) relationship with the EU after exiting. On the table are different options with varying degrees of economic integration between the UK and the EU. The UK government faces a key trade-off between the economic benefits of integration and the domestic political ‘cost’ of a loss of sovereignty. In particular, the current challenge consists of carefully weighing up the main promises of the Leave campaign - curtailing free movement of labor from the EU, stopping payments to the EU budget and taking back control of law-making - against losing access to the EU Single Market, which currently takes 44% of all British exports (2015).
The EU Single Market exists for the benefit of all the EU’s 500 million citizens and allows businesses to operate unhindered in all member states. A functioning Single Market where goods, services, people and capital move without tariffs or other restrictions stimulates trade and competition, improves efficiencies and helps cut prices.
Beyond the Single Market, UK access to European research activities could be in danger. This includes access to European research and development (R&D) funds and collaboration networks. EU programs, such as the world’s biggest R&D program, Horizon 2020, as well as one of the EU’s public/private partnership programs, the Innovative Medicines Initiative, fund and support the development of new, innovative products. The EU research budget invests heavily in UK healthcare and life sciences research, and the EU research community benefits from the active engagement of UK universities and industrial laboratories taking part in joint research programs.
Bayer is a German-based company with a presence in the UK that focuses on R&D and marketing of the company’s products. At present, Bayer’s core interests lie in maintaining a strong UK R&D base, as well as barrier-free access to the UK market.
- Not being headquartered in the UK, it is vital for Bayer’s UK business that a future UK-EU relationship is governed by an economic model with maximized economic integration: Goods, services, people and capital should continue to move freely and without any tariffs or other barriers.
- Bayer’s current UK presence focuses on R&D as there is a long tradition of bioscience research excellence in academia and clinical research. In order to maintain a high quality of R&D, the UK should continue to participate in EU R&D funding programs such as Horizon 2020 as they have an important network effect.
- Bayer sees a strong need for harmonization and continuity of EU legislation in the field of healthcare, especially regarding the maintenance of a stable EU regulatory system and functioning of the European Medicines Agency. It will also be key to achieve common standards in terms of intellectual property and patent requirements (e.g. the Unitary Patent System). Of particular importance for Bayer’s Crop Science business is the maintenance of the common market for seeds as well as the harmonized variety registration system.
- To uphold the stability of current economic operations, it will be important to conclude an interim agreement including regulatory cooperation. To also guarantee access in the long-term, a future trade agreement including a mechanism for regulatory cooper-ation should be envisaged.
Political Position on Digital:
Importance of Data Sharing
The so-called digital revolution is transforming society, companies and entire industries. Digital technologies have the potential to increase the effectiveness and the efficiency of analytics, production and services.
In the life science sector, digital business models will be key to ensuring countries’ and companies’ competitiveness in a globalized world. For Bayer, digitization is a strategic element in the company’s business divisions.
Bayer is advancing Digital Farming capabilities, namely local, data-driven insights that improve decision-making in the field, help to predict what lies ahead and give actionable recommendations. Digitalization has the potential to give farmers timely, field-specific information for selecting seed varieties, determining ideal timing and dose rate for inputs as well as recognizing plant stress factors at early stages.
Also in healthcare, digitalization impacts the entire value chain, from research and development to manufacturing and customer interaction. Bayer is promoting self-care and consumer health through digital approaches and is making targeted investments to further the drivers of digitalization for healthcare.
As part of the digital revolution, data and advancing the data economy are increasingly seen as a key resource that drives economic growth, innovation, competitiveness and societal progress. At the same time, these new technologies are also disrupting the existing relationships in society, thus requiring an adequate legislative framework. Consequently, the need to ensure continuous protection of personal data under existing data privacy rules is a key issue in the political discussion. Governments are also discussing how to best facilitate accessibility and exchange of non-personal data for third parties.
- Data protection / data privacy is a critical issue for life science companies. The highest protection standards are essential particularly where patient data is concerned. However, the need for patients’ consent to use their data in medical research is often too narrowly formulated. Bayer, together with many leading health research organizations supports a broad concept of patient consent that e.g. allows for the future aggregation of data. A definition of personal data protection that is too narrow could also run counter to public health goals in this emerging field. The further development of standards for data-anonymization is also key.
- The exchange of non-personal data is vital for the data economy to achieve the potential it promises. However, intellectual property and business secrets should not be compromised. Holders of large data sets for example often share or grant access to other parties and accelerate research and development. Bayer supports this, as long as it remains voluntary, under freedom to contract and to the benefit of all involved parties. Bayer’s Digital Farming business for example works with many organizations, where data is shared to foster research and development of new technologies.
- Portability, interoperability and standardization of data should be facilitated through joint industry standards, not legal obligations / legislation to support the best use of data.
- As an overall precondition for the success of the data economy, it is vital to ensure there is a reliable flow of data so that new data- based innovations may be brought to the market. Bayer supports the free movement of data across borders and opposes unnecessary regulation for data localization.
Energy Transition and Energy Efficiency:
Sustainable Security of Supply
The energy transition involves an ambitious expansion in renewable and regenerative energy and a decrease of fossil-fueled energy production. The goal is decarbonization and a stable supply whilst minimizing ecological problems.
Energy transition was also a major element of the 2015 Paris Agreement, within the United Nations Framework Convention on Climate Change. The countries signing the Agreement committed themselves to reduce net greenhouse gas emissions to zero between 2045 and 2060 to help fight climate change.
The European Union and its Member States are seeking to play a pioneering role in decarbonization. The EU is actively working towards becoming a low-carbon society, by cutting emissions and investing in energy reduction initiatives, such as e.g. clean technologies.
The energy transition also includes the use of efficiency enhancing methods, such as cogeneration or combined heat and power (CHP). It includes the efficient recovery of released heat in industrial processes. Since production facilities require heat on a year-round basis, heat and electrical energy are generated in a combined process, which is highly efficient and reduces the need for additional heat or energy sources.
- Bayer fundamentally supports the energy transition and supports the goal of the Paris Agreement to switch power and heat supplies from fossil fuels to renewable energies.
- Bayer aims to continuously improve the energy efficiency of its production facilities and along the entire value-added chain to find innovative market solutions that can help to achieve energy savings. Bayer has set itself the ambitious target to increasing energy efficiency by 10% by the year 2020, compared to the base year 2015.
- There are also challenges associated with the energy transition. One concern is the rising energy prices, which have a detrimental impact on the competitiveness of production sites which face already high energy prices (e.g. Germany). Energy prices also have an effect on competitiveness and sustainability of industries. Furthermore, we need to ensure security of energy supply. It is essential to draw up plans how renewable energies are to be integrated into sustainable supply strategies to ensure future security.
- One core element of Bayer’s efficiency strategy is the use of cogeneration in energy production in Germany. The legal framework conditions to complement renewable energies with cogeneration technology are increasingly favorable.
Political position on the Financial System for the Real Economy
Since the global economic and financial crisis in 2008, efforts have been made at international level to identify the main reasons for the crisis and to come up with appropriate solutions to prevent a similar crisis in the future.
The Group of 20 (G20), which brings together the heads of governments of the main global economies, seeks to strengthen the global financial system and to improve the supervision and regulation of financial market participants.
G20 coordination was established on recommendations regarding a) strengthening transparency and accountability; b) enhancing sound regulation; c) promoting integrity in financial markets; d) reinforcing international cooperation and e) reforming international financial institutions. Implementation has however been the responsibility of the national level.
In addition, other institutions such as the World Bank, the International Monetary Fund or the Basel Committee which is the organization of central bank governors, are influencing rules for risk supervision and capital requirements for banks.
Against this background it has become increasingly important for the real economy – non-financial companies which use financial services – to make its voice heard. Companies of the real economy supported the strengthening of capital requirements and additional measures against possible bank failures following the crisis. However, certain regulations and plans for additional rules for more financial stability may have unintended consequences for the real economy. It is thus important to distinguish between financial and non-financial companies to understand the true impact of the new regulatory framework. Where possible, exemptions and different rules should thus be applied to non-financial companies.
Bayer relies on stable financial systems as the lending capacity of financial institutions is key for financing the investment activities of the real economy. The Basel Accords seek to maintain sufficient levels of capital in banks so as to avoid future bank collapses. However, higher levels of capital indirectly can lead to a reduction in lending which in turn may inhibit economic growth. Bayer therefore calls for an impact analysis of overall economic consequences, not only on the financial sector, before moving to stricter global standards in this area.
- As a company headquartered in Germany, Bayer supports promoting a stronger capital market in Europe. Proposals to introduce a Financial Transaction Tax and attempts to draw non-financial companies increasingly under financial regulation could hinder the development of a European capital markets union.
- When regulating financial systems the difference between financial and non-financial companies should always be taken into account. Non-financial companies often use derivatives for hedging in order to manage business risks. The use of derivatives for that purpose as opposed to speculative purposes is of strategic importance and adds to the resilience of the financial system. Companies in the real economy should therefore not be subject to the same obligations as financial institutions, such as central clearing or reporting requirements that would significantly reduce incentives for companies to use derivatives for hedging purposes.
Bayer does not file for or enforce patents in the Low Income Countries (LICs) for human pharmaceutical products or vector control products. The foregoing policy will apply as long as a country remains an LIC according to the World Bank classification and the country’s government does not enact policies which warrant a change in filing or enforcement strategy. Moreover, Bayer joined the Patent Information Initiative for Medicines (Pat-INFORMED), which provides basic patent information about approved Bayer products and makes them publicly available.
Gender Balance and Cultural Diversity: Good for the Company
Women continue to be underrepresented in senior management positions. In many countries, including in the European Union, there is considerable discussion about how to change this situation – for example by introducing legally binding quotas. In Germany, for instance, a quota was agreed in Spring 2015 relating to the number of women on Supervisory Boards, and this is to be implemented incrementally starting in 2016.
However, achieving a good gender balance is not the only task, cultural diversity is also a priority. Both are important – 60 percent of all university graduates worldwide are women, and 65 percent of all purchasing decisions are made by women. In 10 years, half of all consumers globally will come from emerging markets and, in five years, four out of 10 university graduates will come from China and India alone.
- Since the end of 2010, Bayer has been on a journey to evolve the balance of different nationalities and genders in our management teams.
- We believe this focus ensures our future competitiveness and business success:
- We know that culturally and gender balanced teams bring about more innovation.
- We need to leverage 100% of the talent pool across all countries and genders.
- We need to reflect and understand 100% of global customers across all countries and genders.
- We support managers in learning how to effectively hire, develop, promote and retain managers across all cultures and genders. We support the learning process associated with this in seminars. Our most senior managers are responsible for this process and drive it forward.
- We have ambitious goals and are making good progress toward achieving them. This is why we also take a relatively relaxed view of quotas. We are making good progress on our own.
- By the end of 2017, the proportion of women in our upper management levels had risen to 32 percent. We aim to increase this proportion to 35 percent by 2020.
- People from approximately 145 countries are employed around the world at Bayer. In terms of cultural diversity in our upper management levels, around 21 percent of managers come from countries outside Western Europe, the USA and Canada. We aim to increase this proportion to 25 percent by 2020.
Genome Editing: Science and Risk-Based Regulation
Scientific breakthroughs in genome editing methods mark major progress in the life sciences. They offer huge potential for benefits in human and animal therapeutics, in the breeding of plant varieties with new characteristics and in the development of new biological tools to fight pests and diseases. They offer potential socio-economic and environmental benefits for society. At the same time, these breakthroughs challenge the current legislative framework and trigger political discussions. They also have the potential to divide public opinion.
As a leading Life Science company, Bayer is at the forefront of these advances and has an important role in contributing to societal debates through engagement of its experts, management and especially Leaps by Bayer when it comes to potential applications of genome editing technologies as future therapeutics. Bayer has access to genome editing technologies and uses these in research for humans, plant and animal sciences, as well as micro-organisms.
At Bayer, our genome editing research aims at altering DNA in a precise, efficient and responsible way. This includes using targeted genetic scissor methods to cut, edit, add and repair DNA. There are several methods available to date including CRISPR/Cas9, Zinc Finger Nucleases, or TALENS as well as other related technologies that encompass different possibilities: removing or introducing genes or nucleotides, activating or silencing certain genes.
Recent genome editing developments offer new opportunities for future application as therapeutics to cure certain diseases and are a real breakthrough. While in the plant science field, many questions have already been discussed, debates on genome editing in humans are only beginning. Thus the products of genome editing will require a new regulatory environment when applied in humans.
- Products of genome editing will carry not only benefits but also potential risks; these need to be understood and managed. Therefore risks should be assessed in a science-based way and then be managed or avoided. However, risk management should always take into account the benefits provided by the products.
- Bayer, along with leading scientists, advocates an appropriate regulatory approach regarding genome editing in plants, which not only takes into consideration the technical process of breeding / production but also the product of plant breeding.
- Bayer backs the position to not alter the human germline and supports a respective moratorium of scientists, as agreed in 2015. Hereditary alterations are the line that should not be crossed. However, non-germline DNA changes in humans are already today ethically justified as therapeutic options to cure illnesses as they are not inheritable by the next generation.
- Many questions remain yet unanswered: Measuring for example the safety of new therapies and organizing access to and distributing the costs of these new therapies in a balanced way will need to be addressed by society in the years to come. Finding an appropriate role for intellectual property and determining the fitness of health technology assessments is going to be crucial. Thus, Bayer calls for a societal debate on a regulatory framework for genome editing that will enable innovation.
Global Health Priorities in the German Global Health Policy Strategy Process
Resilient and future-oriented healthcare systems are essential – for individual well-being and for our societies, for economic growth and for development. Research-based pharmaceutical companies can contribute to this with innovative medicines. As an innovative life science company, Bayer offers a comprehensive One Health concept including healthcare and nutrition. Bayer thus contributes to the attainment of important United Nations Sustainable Development Goals (UN SDGs) adopted in 2015 as the worldwide “Agenda 2030” to overcome global challenges such as poverty and hunger.
In that context, the German Government is currently setting up a global health strategy. Non-state actors have been asked to contribute. Bayer welcomes this approach, contributed to the Industry Position Paper and is open for dialogue. Bayer believes that all - state and non-state actors have important contributions to offer, thriving together for realizing global health objectives which are most prominently defined under SDG 3 that seeks to “ensure healthy lives and promote well-being for all at all ages”.
The Challenge: Shift in Global Disease Burden
International organizations and nongovernmental stakeholders are at present mostly focused on fighting communicable and neglected tropical diseases (NTDs) in order to counteract the current burden of disease in middle- and low-income countries. While this is important, the worldwide increase in non-communicable diseases (NCDs) poses a particular challenge. According to OECD, the major NCDs groups account for together nearly 60 percent of health spending1. On a global level by 2016, over 70 percent of all deaths were attributable to NCDs: 44 percent to cardiovascular disease, 22 percent to cancer and 9 percent to pulmonary diseases, with the rate of NCDs rising disproportionately in middle- and low-income countries2. Innovative solutions for the treatment of oncological and cardiovascular diseases are needed to enable universal health coverage.
What themes should be strategic priorities?
Universal Health Coverage (UHC): Governments should promote UHC as defined in SDG 3.8 and ensure that the treatment of NCDs (SDG 3.4) is understood to be an integral part of UHC. Prevention, treatment and reimbursement - also of innovative medicines - should be promoted and guaranteed worldwide not just for NTDs, but also for oncological, cardiovascular, respiratory and mental diseases. Also, better access to self-care through daily choices on exercise, diet, hygiene and self-medication has an increasingly important role in strengthening the sustainability of global healthcare systems.
Value of Innovative Medicines and NCDs: Governments should engage in finding innovative solutions for treating NCDs. They should communicate the value of innovative medicines, support innovation through research funding and ensure an innovation-friendly legislative framework. Promoting the protection of intellectual property rights can go hand in hand with promoting access to medicines by strengthening health care systems. Innovative medicines can help to build resilient healthcare systems, when their value is determined in a holistic way.
Digitalization and Artificial Intelligence: Digitalization in healthcare is an enabler of more effective and patient-centered treatment. Additionally, digital solutions can serve in healthcare systems analysis. They can help to free up resources for innovative healthcare solutions to offer more value for patients, healthcare systems and society. A digital-friendly legislative framework is therefore needed.
One Health: A prerequisite to health is nutrition. Governments should therefore advocate for the acceptance of technology and new approaches to fighting hunger and malnutrition under SDG 2. All interests along the entire supply chain should be valued, as also those of smallholder farmers in rural areas.
Life Science Innovation for a Better Life
Innovation is at the heart of Bayer and as a Life Science company, guides its business decisions. The company employs more than 16,000 employees in R&D directly and spent €5.3 billion on R&D in 2019. Bayer is following an open innovation strategy with many partners from academia to start-ups.
Science, research and development are of key importance for a country’s economy. However, turning research results into products has been addressed to a lesser extent, although this is where the value of R&D is captured. The important step of commercialization distinguishes innovation from research.
Innovation can face many hurdles. These include regulations that discriminate against biotechnology products, the denial of patents for pharmaceuticals or plant innovations or delayed registration of consumer care products. These hurdles are usually not specifically designed to stifle innovation. However, in combination they can have a dangerous inhibiting effect.
Some countries lack fundamental preconditions for research and innovation, such as access to R&D, personnel or capital. Sometimes the right level of intellectual property protection necessary to incentivize innovation is not granted. In other places it is not possible to bridge the gap between research and commercialization. Things can go wrong in many ways, but what connects these problems is that a coherent, conducive framework for innovation is often lacking.
Innovation works best when different actors come together in an innovation ecosystem: big companies, start-ups, suppliers, customers, universities, research institutes and others.
Bayer advocates for legislative frameworks that support innovation. While these can take different forms depending on local circumstances, they have in common that they create the necessary conditions for world-class R&D, the right incentives for commercialization and a regulatory framework to allow long-term innovation strategy planning.
- Bayer calls for the introduction of an innovation principle to examine the impact of new legislation on innovation. An innovation principle would set innovation on a par with other considerations in policy-making. It can thus help to create better conditions for research and innovation and to avoid unnecessary regulatory burdens.
- Bayer also advocates fostering innovation through collaboration between key stakeholders: Industry, academia, start-ups, society, politicians, citizens are all necessary to create a dynamic and productive innovation ecosystem. This should be actively encouraged and facilitated by policy.
- Bayer calls for the implementation of a coherent innovation policy to foster innovation: robust STEM (Science, Technology, Engineering and Mathematics) education, incentives for R&D for example through tax credits, strong intellectual property protection and research programs that support international collaboration and exchange of industry with academia.
- To create a reliable innovation ecosystem, political decisions should be science based. Science cannot dictate decisions; it can only inform decision-makers. It can offer a range of realistic policy options and make their impact transparent.
Intellectual Property Rights:
Protection is Essential for Life Science Innovation
Bayer is a research-driven company. In 2019, the company invested € 5.3 billion in R&D. Society benefits from innovation through the prevention, alleviation and treatment of diseases and a reliable supply of high-quality food, feed and plant-based raw materials.
Intellectual property rights (IPR) are a crucial part of the innovation process, especially when it is driven by significant investments, specialized research and a certain risk of failure. This is the case in life science research, such as plant breeding, pharmaceutical research or crop protection development. Without effective patent protection, product development and investment in R&D in the heavily regulated life science sector are not profitable.
Companies like Bayer safeguard investments by protecting the R&D outcome against copying by those who do not incur this cost and risk. Intellectual property rights prevent third parties from reproducing the new product without the innovator’s consent for a limited period of time. Although the limited exclusivity for the inventor ends after the applicable term, Bayer’s innovations will remain available to society. The publication of patent applications triggers further innovation by providing the public with knowledge of an invention’s properties. This pro-innovative effect of patents is supported through exemptions in patent law, allowing R&D, in many instances already during the patent term.
Intellectual property rights include for example patents, trade secrets, regulatory data protection, trademarks, designs, plant variety rights as well as patent term restoration measures, e.g. supplementary protection certificates.
In addition to harming the innovator, infringements of intellectual property rights such as counterfeit drugs or pesticides can pose a significant threat to human health and the environment.
- Bayer calls for strong IPR protection. Rising R&D costs and long development periods make IPR necessary. Industry needs predictability with regard to IPR protection and its enforcement because of the duration and complexity of innovation processes.
- Future free trade agreements and other (international) agreements must include provisions on IPR protection and enforcement. The WTO agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an important milestone in this regard.
- Bayer acknowledges society’s demands regarding the transparency in IPR. Bayer participates in the Orange Book on pharmaceutical patents in the United States and the Patent Information and Transparency Online (PINTO) database in the European Seeds sector.
- Besides patents and patent term restoration, IPR measures must include regulatory data protection. There is a significant gap in this regard when prescription medicines are changed to over-the-counter medicines. Increased data requirements in this field mean that data protection periods should not be less than 3 years.
- IPR are increasingly challenged, as it is claimed that the patent system restricts access to medicines and seeds. While the patent system is a precondition for the development of innovative products, it creates incentives through temporary protection for the inventor. However, in Bayer’s view incentives for innovation and access to innovation is generally well balanced in intellectual property systems in the developed world.
Legislation and Politics:
The Essential Role of Science and Transparency
Bayer’s products are subject to a wide range of regulation to ensure their safety and efficacy before they come to the market and ultimately to the consumer. Clinical trials determine the efficacy and the benefit-risk profile of pharmaceuticals and consumer health products. The prescription and application of medicines is mostly in the hands of doctors and pharmacists. Crop protection products are extensively tested in scientific toxicology studies, and their application is restricted by tight thresholds and close monitoring. Some Bayer products can be sold freely over the counter, while others have to adhere to publicly regulated prices.
Bayer supports regulation and the underlying legislation where it protects human health and the environment. However, policymakers face conflicting policy goals, for example human and environmental protection, innovation capacity, business competitiveness, employee rights and societal welfare.
As policymakers consider this variety of policy goals, based on their values and political views, legislative processes have become increasingly complex. They have to come up with new ideas to transparently and reliably transform this complexity into manageable legislative options.
There are many examples of emerging best practice: The EU has started a Better Regulation agenda and the United States has progressed with its public notice and comment process. At the same time, impact assessments have become increasingly standard and new processes for scientific guidance and risk assessments are being introduced in a number of jurisdictions.
However, attempts to make legislation and regulation more predictable, transparent, science-based and innovation-friendly should be systematic rather than arbitrary.
Bayer supports a strong and sensible legislative and regulatory oversight in its sectors, particularly in the area of human and environmental safety, that does not inhibit innovation. We believe that four areas are important to improve the legislative process:
- Bayer favors new approaches to decision- making such as the OECD’s recommendations on Better Regulation. For Bayer it is essential to improve the quality and accountability of policy and law-making. We emphasize the importance of early-stage and more transparent impact assessments that are open to stakeholder contributions.
- Bayer supports science-based decision-making. Scientific evidence should be based on academic consensus. In order to use the best available knowledge when preparing and deciding on legislation, institutionalized mechanisms should advise governments on options and their impact from a scientific point of view. An institution providing such advice should be accountable for the quality of scientific knowledge used in decision-making.
- Bayer asks for the use of an innovation principle to systematically take into account the impact of legislation on innovation. It would work complementary to the precautionary principle, allowing for precaution, while at the same time enabling innovation.
- Bayer supports transparency in legislative processes. For example, government bodies should make their legislative proposals transparent. Bayer commits to transparency and works towards measures that will put transparent regulatory data online, under the premise that intellectual property is not disclosed to competitors.
Political Position on Post-Clinical-Trial-Access
Bayer’s actions are guided by its vision “Health for all, hunger for none”. Bayer Pharmaceuticals focuses on researching, developing and marketing specialty-focused innovative medicines that provide significant clinical benefit to individual patients and society as whole. Clinical trials are a key requirement for doing so and depend on the participation of patients, on whom the efficacy of an innovative medicine is tested. To ensure that safety and well-being of patients remain paramount, Bayer conducts clinical trials in accordance with international guidelines, current national and local laws and regulations, and the highest medical, scientific and ethical principles1.
By participating in confirmatory clinical trials2, patients contribute tremendously to the research and development of new drugs. However, from the successful completion of a clinical trial until commercialization of the new drug3, critical time may elapse. Bayer’s position for cases where trial participants experienced a clinical benefit is that they should be granted continued and cost-free access, to bridge the period until the drug is available on the market.
To that end, Bayer has developed this Post-Clinical-Trial-Access Position, setting general standards for Bayer to review and approve requests for continued access of trial participants to innovative medicines until their availability on the market, if:
- Sufficient clinical safety and efficacy data suggest a favorable benefit-risk profile for the proposed use
- Access to the medicinal product before approval from local authorities is permissible according to the local laws and regulations from where the request originated
- The patient:
- Is suffering from a severely debilitating or life-threatening disease or condition which cannot be treated satisfactorily by approved medicinal product in the country where the request has originated
- Has received appropriate standard treatment without success or no standard treatment exists for the subject’s condition and no satisfactory alternative approved medicinal product is available
- Is ineligible or, due to geographical limitations, cannot participate in any ongoing clinical study
This Bayer Post-Clinical-Trial-Access Position is implemented by specific internal Standard Operating Procedures (SOPs) and is part of a larger set of measures, designed to provide patients with full transparency as to their participation in clinical studies conducted by Bayer4.
Pharmaceutical research and development are a vital part of any healthcare system. Through participation in confirmatory clinical trials, patients significantly contribute to that process. Post-Clinical-Trial-Access is an adequate way to swiftly derive the health benefits of innovative medicines.
1 These guidelines include: Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS); International Ethical Guidelines; Applicable ICH Good Clinical Practice (GCP) Guidelines; Applicable laws and regulations; Bayer internal Standard Operating Procedures.
2 Confirmatory trials, or Phase 3 trials, are done to confirm that a new treatment helps people who have the disease or condition for which the treatment was developed. The European Medicines Agency defines them as “adequately controlled trial[s] in which the hypotheses are stated in advance and evaluated.” (ICH Topic E 9 Statistical Principles for Clinical Trials)
3 For the period before commercialization, the drug is referred to as unmarketed investigational medicinal product (IMP). The term “unmarketed” means that the IMP has not been approved or the sale of the IMP has not fully commenced (for example due to ongoing reimbursement discussions locally) or that the IMP may be approved but not marketed in the respective country or that the product has been discontinued or removed from the market in the country where the request has originated.
4 Further information for patients around Bayer clinical trials can be found at: https://clinicaltrials.bayer.com/transparency-policy
Political Position on Trade
Bayer is a multinational company with roots in Germany and a presence in more than 87 countries worldwide. Trade is essential for our business. Bayer’s global trade flows totaled around €18.5 billion in 2016. The company’s business depends on a complex value chain with R&D being conducted in many different places, geographically dispersed production, and largely nationalized regulatory environments.
Increasing free trade in the past decades has not only benefited business but also citizens. Many more people have been able to participate in the global economy via improved trading opportunities. This has boosted economic growth and development which, in turn, has helped to improve living conditions. According to the United Nations, hunger, poverty, child mortality and illiteracy have substantially dropped in the past decades.
However, in recent years, protectionist policies have spread, as countries seek to shelter industries that are not competitive. This can take the form of local ownership requirements, forced localization of production, import substitution or compulsory licensing. Additionally, some countries are exploiting policy instruments of the World Trade Organisation (WTO), such as anti-dumping investigations for raising tariffs.
Non-tariff barriers hinder trade. While these are often not fully-fledged protectionist measures, they can de-facto serve to close markets off. According to the WTO, the stockpile of trade restrictive measures grew from 546 in 2010 to 2,835 in 2016. This excludes national sanitary and phytosanitary measures as well as technical barriers to trade of which 35,266 were notified by end of 2015.
This creates a significant burden for Bayer’s trade, at the same time raising access barriers for patients and consumers to its products.
Bayer advocates a transparent, rules-based trading system, preferably regulated at a global level through international institutions such as the WTO. Any such system must be democratically accountable and efficient to tackle protectionist policies as effectively as possible.
Bayer seeks to facilitate trade for the efficient functioning of its value and supply chains. Customs regulations, rules of origin and export subsidies are examples of rules that govern and can painstakingly complicate trade when they diverge too much. It is thus in industries´ interest to achieve an increasingly simple, harmonized system of trade facilitation.
Bayer calls for improved regulatory cooperation and coherence. Non-tariff barriers are hampering free trade, especially in a highly regulated area such as the life sciences. The company operates according to international and national standards and advocates fewer non-tariff barriers.
Bayer is an innovation-driven company with significant investment in R&D. The value of its products relies on intellectual property. This requires protection as products might be copied by competing companies. To enter a certain market it is thus important to find measures that secure the investment in R&D. Bayer advocates high standards of intellectual property and investment protection that should be internationally aligned.
Bayer supports developments that progressively shape the integration of national markets, such as the proposed Multilateral Investment Court. Balancing the rights of investors and states, it would transparently and legitimately safeguard foreign investment.