Product stewardship
Performance Report

Product stewardship

We inspect and monitor all Bayer products in applications known to us with regard to potential health, safety, environment and quality (HSEQ) risks along the entire value chain – from research & development and production through to their use and final disposal. In this way, we ensure that our products – provided they are properly used – do not have any negative impact on humankind or the environment. We also endeavor to make sure that our products are manufactured, stored, transported and marketed in accordance with the relevant laws and regulations of the respective country.

Since 1994, our management of HSEQ has been aligned to the voluntary Responsible Care initiative of the chemical and pharmaceutical industry. We signed the modified version of this, the “Responsible Care Global Charter,” in 2006. To achieve ongoing improvements in health care, safety and environmental protection, our subgroups and service companies work with five-year roadmaps.

Information on substances

Virtually all the products manufactured by Bayer are subject to extensive and stringent legislation concerning the publication of information. Relevant safety information on the materials used – be they raw materials, intermediates or end products – is available across the Group in the form of databases or safety data sheets. Every product is provided with the necessary warnings so that our employees, sales partners and customers can transport, handle, store, use and dispose of our products safely. This also ensures that the recipient is informed of the risk potential of the products. Our employees are given regular training on the safe handling of the substances and mixtures and in the use of appropriate safety equipment. They also learn to take the necessary emergency and rescue measures. Special instructions exist for handling the various chemicals. 

With our commitment to product stewardship, we support the goal of the e.u. chemicals policy (REACH link), to further improve the safety of everyone involved along the product chain and to enhance consumer safety and environmental protection. In addition, we endorse the aim expressed at the World Summit on Sustainable Development (Johannesburg 2002) to achieve a uniform global system of classification and labeling for substances and mixtures. We therefore actively participate through the various industry associations in the process of politically shaping and implementing the Globally Harmonized System (GHS) in the context of other relevant regulations in Europe.

All the subgroups are in the process of implementing the new regulations in their electronic systems. As far as product labeling is concerned, Bayer HealthCare is working on building up a global database in connection with the introduction of the GHS, and has already done this in the E.U. with the implementation of REACH. At Bayer CropScience, we collect all product labeling information in our new database, “E-label Server.” At present, it covers the products we market in Europe and parts of Africa and Asia. By the summer of 2008, we aim to publish a modified version of our “External Adverse Incident Reporting Guideline,” which regulates how incidents are to be reported. Bayer MaterialScience (BMS) distributes the necessary label information to the connected label print systems using its ehs (Environmental, Health, Safety) system. The BMS system does not yet have full global coverage, but the subgroup aims to extend it as soon as possible.

Scientific risk assessment of chemicals

A key element of product safety at Bayer is the scientific risk assessment of chemicals. We have systematically and effectively organized our activities relating to chemical safety and given them the necessary funding. A comprehensive study of the effects of our products on humankind and the environment is an integral part of product development. For example, we study the effects of our crop protection products on representative organisms in water, soil and air. We also make our expertise in the field of environmental analysis accessible to our customers via the services of CURRENTA. In addition, we participate in many research projects dealing with the risk assessment of industrially manufactured substances as part of the Long-Range Research Initiative set up by the international chemical associations. We endorse the aims of the European Environment and Health Action Plan, and we support scientific risk assessment via biomonitoring link. We are also involved in many scientific bodies such as the European Center for Ecotoxicology & Toxicology of Chemicals (ECETOC), the Society of Environmental Toxicology and Chemistry (SETAC), and the International Life Sciences Institute/Health and Environmental Sciences Institute (ILSI/HESI). .

Dealing with new technologies

Nanotechnology and biotechnology, two areas of science that are very much oriented to the future, offer enormous potential for products and applications in the fields of health care, food, environmental protection and high-tech materials. As part of our product stewardship policy, we regard it as an integral part of any development process to clarify not only the opportunities offered by a new product or a new technology, but also the potential risks.

Bayer has acquired sound knowledge regarding the safe handling of nano-materials such as Baytubes®. This applies not only to the physical and chemical characterization of these materials but also to the analysis of their toxicological and eco-toxicological behavior. The basis for our dealings with nanotechnology is provided by the legal framework, which ensures adequate safety. The “Bayer Position on Nanotechnology” and the “Bayer Code of Good Practice in the Production and On-site Use of Nanomaterials” put this framework into context for our employees, and are also available on the Internet.

Our involvement in genetic engineering, too, is naturally governed by the relevant legislation. We also have a “Bayer Group Position on the Responsible Use of Gene Technology” which was most recently updated in 2007. We respect the concerns about genetically modified organisms (GMOs) expressed by society, but we share the consensus view expressed by the scientific community that GMOs do not represent a safety risk when the legal requirements are observed. They are tested thoroughly before they are given regulatory approval, and undergo a stringent registration procedure. Bayer CropScience respects the right of consumers to be informed and to choose freely which foods they want to eat. Appropriate labeling of genetically modified foods can improve confidence in and acceptance of these products.

Traces of LLRice601, genetically modified rice, were found in conventional rice in the United States. Bayer CropScience is working closely with the responsible U.S. authorities and making available its know-how and technical expertise.

Animal studies are indispensable

We are required to carry out studies involving animals at various phases of a product’s development in order to ensure that our products are safe and to comply with regulatory requirements. We are also legally bound to carry out such studies. Our “Policy on animal welfare and animal studies” commits us to limiting the use of animals to the acceptable minimum and to employing alternative methods wherever possible. Bayer is a participant in the European Partnership for Alternative Approaches to Animal Testing (EPAA), whose aim is to implement the “3R” principle. 3R stands for Reduction (of the number of experimental animals), Refinement (of experimental methods) and Replacement (of animal studies by other procedures). We also contribute to the development and validation of alternative methods through several national and international research projects, e.g. in collaboration with the European Center for the Validation of Alternative Methods (ECVAM). It is not, however, possible to eliminate animal studies completely. So far no way has been found of testing the reaction of the whole organism or complex functions in cell culture or in an isolated organ. Since 1989 we have reduced the number of animals used throughout the Bayer Group by almost two-thirds, achieving a figure of roughly 160,000 per year in 2007.

Stringent drug safety requirements

The entire process of manufacturing medicinal products and medical devices is governed by exceptionally strict quality requirements. These standards are known collectively as “Good Manufacturing Practice” (GMP) and are inspected at regular intervals by the regulatory authorities and external auditors. Patient safety is Bayer’s overriding priority. In this context we work closely with regulatory authorities such as the Food and Drug Administration (FDA) in the United States, the European Agency for the Evaluation of Medicinal Products (EMEA) and the Federal Institute for Drugs and Medical Devices (BFARM) in Germany. The Global Pharmacovigilance function, which employs more than 300 people worldwide, is responsible for drug safety at Bayer. It ensures that all the available information concerning the adverse effects and interactions of the medicinal products marketed or developed by Bayer is compiled and evaluated on an ongoing basis. In this way the risk-benefit potential of our products can be monitored continuously even after regulatory approval has been granted.

Responsibility for patient safety begins when clinical trials are carried out. Global Drug Safety reviews the study design to ensure that patients’ health is protected and receives relevant information on the benefits and risks of drugs both during and after the study; this information is entered in the drug safety database and undergoes in-depth analysis. During the study, medical experts carry out regular interim analyses of information which may point to possible serious adverse effects.

A risk management plan is drawn up as part of the process of applying for marketing authorization for a medicinal product, and this document lists the drug safety requirements that the product has to meet once it is on the market.

Once the product has been given regulatory approval, all the spontaneous reports of adverse events submitted anywhere in the world by physicians, patients and the authorities, data from publications and the results of further studies are compiled and entered in the drug safety database; the database is reviewed continuously for indications of new risks associated with the product. Product experts in Global Drug Safety use these data as the basis for annual reports on the safety of the products assigned to them. If new adverse effects or risks come to light, interdisciplinary committees initiate appropriate measures, such as modifying the text of the patient information leaflets (PILs) and informing the authorities. These measures include direct communications to physicians, warning them of possible adverse effects and providing information on the correct way to use the product. For example, Bayer recently modified the PIL for Levitra® to include information on a rare adverse effect which had been observed in patients using this treatment for erectile dysfunction.

Bayer Schering Pharma has started the Pharmacovigilance 2009 project on its own initiative with the aim of reinforcing drug safety even further. The project includes a new database that gives technical support to the newly designed process sequences, for example to enable more rapid signal detection and for the development of risk management plans.

For Bayer HealthCare it also goes without saying that information about the clinical trials being carried out with people should be made available to the general public. The Clinical Trials Registry and Results website operated by Bayer HealthCare contains information about the clinical trials commissioned or (co-)sponsored by Bayer and is intended to increase the transparency of clinical research at Bayer for patients and health care professionals. It includes new substances and studies with pharmaceutical or biological products which have already been given regulatory approval and which are manufactured, distributed, marketed or promoted by Bayer.

Responsibility for animal health

The Animal Health Division of Bayer HealthCare produces and markets more than 100 different veterinary drugs and grooming products for livestock and companion animals. The highest quality and safety standards apply to our animal health business, as they do to all our activities. We are accordingly investing in an extensive research & development program, and take great care to ensure that our production processes and the way our veterinary drugs are marketed and distributed comply with the highest possible standards of quality, efficacy and safety for animals, people and the environment. We also provide targeted training and publish wide-ranging information in order to educate veterinarians and end users about the appropriate and responsible use of our products.

Trasylol® marketing temporarily suspended

Trasylol® (aprotinin) is a drug that is used to control blood loss during coronary bypass surgery. In November 2007, Bayer temporarily suspended global marketing of Trasylol® after interim results of an independent clinical trial (the BART trial) in Canada had pointed to a possibly increased risk of mortality in patients receiving Trasylol®. Post-marketing surveillance studies carried out in 2006 and 2007 had previously reported a possible connection between administration of Trasylol® and serious impairment of renal function, heart attacks, strokes and increased mortality. Once the complete dataset from the BART trial (which also featured in a publication in the New England Journal of Medicine in May 2008) is available, Bayer will work with the principal investigators in the trial to resolve any unclear details. Bayer will carry out a detailed evaluation and analysis of the data and all other relevant published material with the aid of external medical experts, and will work with health authorities to evaluate whether the BART data and all the other recent data have any impact on the risk-benefit profile of Trasylol®.

The drug is still available under special access programs which have been agreed with and approved by the health authorities in certain countries. While the data are being analyzed, Bayer will organize additional measures in the countries which currently have special access programs for the product to ensure that Trasylol® is used in compliance with the approved conditions of these programs. By May 15, 2008, a total of 89 lawsuits relating to Trasylol® had been filed against Bayer in the United States. Bayer is confident of having good arguments against the claims that have been made and will defend itself vigorously in these proceedings.

Product safety at Bayer MaterialScience

Bayer MaterialScience has put a global product monitoring organization in place to record any possible negative effects on health or the environment that could be connected with its products. In addition to the normal reporting obligations, all employees are instructed to pass on any information whatsoever concerning a possible link between negative effects or significant risks and our products to the central product monitoring units. These units collect the information, evaluate it, define suitable countermeasures and monitor their implementation.

With its BayCare® Online system, Bayer MaterialScience has generated an extensive and practical product stewardship tool in the United States. This pools all relevant information for employees and customers on how products from Bayer MaterialScience in the United States are to be used and disposed of safely. The instructions drawn up by Bayer MaterialScience and other experts can be accessed via the Internet.

Product safety at Bayer CropScience

Bayer CropScience organizes numerous training events for customers and partners to ensure that its products are used correctly, safely and specifically in line with our principles of product stewardship. These efforts are supported by the packaging and application technology that we use, such as our new “Abanse®” metering device for banana plantations which we distributed to farmers in 2006. The main aim of the training programs is to minimize the unwanted effects on people, the environment (water, soil, air) and beneficial organisms. Many of our training programs focus on farmers in developing countries. Numerous workshops and on-site training sessions are held to instruct them on the holistic measures of integrated crop protection.

Bayer CropScience introduced the innovative BioBed/Phytobac® system in 2004 for the environmentally compatible cleaning of crop protection sprayers. A container filled with biologically active soil substrate contains micro-organisms which rapidly decompose residues of crop protection products without allowing them to pass into the environment. In late 2007, Bayer CropScience supported the CleanRegion project in the organization of the 2nd BioBed Workshop in Ghent, Belgium, an event attended by delegates from Belgium, France, Germany, Greece, Italy, the Netherlands, Poland, Romania, the Scandinavian countries, Spain, Turkey and the United Kingdom.

Safe disposal of crop protection products

Our responsibility for our products goes far beyond their use; it also includes management of empty product packaging and the disposal of products which have exceeded their shelf-life. We collect empty crop protection containers in countries which do not have functioning waste management systems and ensure that they are disposed of properly. We have started further initiatives to collect empty product packaging in collaboration with national governments and CropLife International, the international association representing the crop protection industry.

Stockpiles of obsolete crop protection products are a problem in a number of countries. Bayer CropScience is working with CropLife to provide financial, technical and human resources to dispose of these stockpiles. A particular focus is on Africa as part of the “Africa Stockpiles Programme” (see the extensive coverage of the Bayer Sustainable Development Report 2006 link).

Replacement of who Class I pesticides

Bayer CropScience only distributes crop protection products which have been granted regulatory approval by the authorities in the countries concerned, which are safe when used responsibly and as intended, and which pose no risk to either people or the environment. We are aware that crop protection products may not always be used correctly under certain circumstances in some Third World countries. This is why the company has undertaken to gradually replace products in who Class I. This is being accomplished, for example, by developing and introducing new active ingredients, products, application technologies and types of packaging. Bayer CropScience has made major progress in recent years, removing many of the Class I products from its portfolio in the past five years. The active ingredients discontinued during this period include methyl and ethyl parathion – we have not sold ethyl parathion in developing countries since 1992 – monocrothophos, oxydemeton-methyl, amitraz and trichlorphon. Bayer CropScience will maintain this approach systematically. Bayer CropScience supports the safe use of its products locally through an extensive training program, some of which is carried out in conjunction with national cotton companies.

However, there are still some vital products for which no alternative is available because it takes a long time to develop and register new crop protection products. In addition, individual countries differ considerably in terms of cultivation and market conditions and the pests that affect them, and this factor makes it impossible to provide a single standardized solution

If no alternatives are available, we promote the safe use of these preparations by providing numerous additional training events for operators. The “Agrovida” program, which Bayer runs in many South American countries, should be mentioned in this connection; it has long proven successful in ensuring that crop protection products are used safely. In recent years, many tens of thousands of people employed in agriculture have taken part in the program. It is designed for various groups of agricultural workers and farmers and focuses on teaching them about risk management concepts, how to use safety equipment properly, and how to avoid product abuse and incorrect application. It involves vocational instructors, farmers, crop protection distributors and independent advisors. Our company organization in Colombia, for example, has received an award from the Ministry of Agriculture for its exemplary handling of this difficult task.

Measures to combat counterfeit products

Counterfeit products and trade in illegal products – particularly pharmaceutical and crop protection products – are a major area of concern for Bayer. Counterfeit products may not only be ineffective, they can also damage health and the environment (see above). We collaborate with distributors, industry associations, the authorities and the WHO worldwide to increase awareness of the problem and to foil the efforts of counterfeiters. We are also concerned to protect patients from the risks to which counterfeit drugs expose them. Bayer HealthCare is intensifying its efforts to raise awareness about this issue and has launched the “Warning: Counterfeit” campaign. Bayer also helps to combat the problem through technical product safety measures, internal and external investigators and legal prosecution. These efforts can only succeed if the industry, the associations that represent it and both government and international organizations join forces. Bayer HealthCare is therefore working with the competent authorities worldwide and is also actively supporting the anti-counterfeiting activities of the WHO in the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Bayer CropScience has adopted specific measures to prevent product counterfeiting in areas known to be problematic. Evident and concealed forgery-proof elements are attached to selected products. These include special holographic seals used in some countries in eastern Europe which can be combined with a HOLOSPOT security label. These elements allow farmers and distributors to identify counterfeit products rapidly and reliably. In Brazil, Bayer CropScience has launched the “Be Original” campaign in which security labels are attached to certain products; the labels cannot be removed intact from the original product, making it impossible for them to be attached to counterfeit goods. These activities are flanked by intensive communication and training for customers and suppliers.

Bayer Technology Services has collaborated with its British partner Ingenia Technology Ltd. to develop a forgery-proof way of marking and identifying objects and packaging. ProteXXion® is the low-cost way of protecting goods against forgery and provides a means of checking the authenticity of a product at every point in the supply chain. ProteXXion® uses a technology called laser surface authentication (LSA) which records and recognizes the individual “fingerprint” of an object, i.e. its natural surface structure. 

Responsible marketing

Our products are marketed in accordance with strict directives. In the medical field, in particular, we are particularly concerned that our activities should be in compliance with the relevant legislation and codes of conduct. This also applies to our efforts to support patient organizations and our marketing activities. We follow the “Ethical Criteria for Medicinal Drug Promotion” published by the WHO, the corresponding codes of conduct drawn up by the international pharmaceutical association IFPMA, and national codes of conduct. We are also a member of the industry associations in all the countries in which we operate and support their codes of conduct.

In the field of crop protection, Bayer CropScience observes the International Code of Conduct on the Distribution and Use of Pesticides supported by the FAO and WHO (previously known as the FAO Code of Conduct).
top
top
top
top
top
top
top
top
top
Search
Search
Download Center
 
Links
 
 
 
Podcast
Podcast-Center
Additional Info Links
Enter the relevant code given in the printed version of the Sustainable Development Report