b) Registration for information media for our members
Once per year, BAH invites its members to the general meeting. The general meeting is one of the organs of BAH, besides the Management Board. The tasks of the general meeting comprise, among others, the election of the members of the Management Board and the endorsement of amendments to the articles of association.
The next general meeting of BAH is scheduled for 24 and 25 September 2019.
The German Medicines Manufacturers´ Association joins forces of about 400 companies. The organs of the association according to German association law are the general meeting and the Management Board. In addition, the Management Board has established committees and advisors who support the work of the association. On the following pages, you will learn more about the panels and the persons represented in these panels.
By company membership BAH, with its about 400 members, is the leading trade organisation of the pharmaceutical industry in Germany. Besides its political activities the work of the association is characterised by comprehensive science and health policy based work for its members.
Good reasons for membership
Advice – We´re here for you: The experts at BAH provide competent advice to you regarding many questions encompassing medicinal products and related subject areas, such as medical devices or food supplements. Fast and comprehensive information: With us, you are always up to date. We inform our members daily about new developments concerning medicinal products. In addition, we offer informative meetings and conferences on different topics free of charge. Analysis: Together with its member companies, BAH analyses both health policy and legal and scientific topics which are relevant for medicinal products, and elaborates expert statements, opinions and position papers. Advanced training, publications and service: With our “Science and Economy Service” (“Wissenschafts- und Wirtschaftsdienst, WiDi“) we offer numerous advanced trainings. In addition, we issue numerous publications, e. g. Standard Operating Procedures (SOPs). Furthermore, our member companies can use additional services, such as the generation of Resistance Tables for antibiotics. Your engagement counts: You can engage actively in our work and by this shape the work of the association.
How can your company become a member of BAH? You can find the application documents for membership to the right.
Please do not hesitate to contact us if you have any questions concerning membership. We would be pleased to assist you.
By company membership, the German Medicines Manufacturers´ Association (BAH) is the leading trade organisation of the pharmaceutical industry in Germany. It represents the interests of about 400 member companies, which create about 80,000 jobs in Germany. Globally operating medicines manufacturers are as involved in the manifold activities of the association as the broadly represented medium-sized businesses.
Besides medicines manufacturers, BAH membership is also comprised of pharmacists, lawyers, publishing houses and agencies, as well as market research and opinion research institutions.
BAH covers the entire range of the industrial landscape from self-medication medicines (OTC) through to prescription drugs (Rx) and medical devices. BAH advocates for secure and responsible self-medication through professional medical and pharmaceutical advice. Therefore, BAH strongly supports the statutory protection of the owner-operated pharmacy as primary institution for distribution.
Contact partner for politics and science
Due to its high degree of professional competence and expert knowledge, BAH is a close contact partner for politicians, authorities and institutions within the healthcare sector, and provides a strong link between various interest groups. In addition to political activities, the BAH is engaged in extensive science-based work in the pharmaceutical area. BAH collects and evaluates information on medicines and elaborates opinions on developments in the pharmaceutical sector.
Logistically, BAH manages these tasks through its offices with about 45 employees. The work of the association is driven and guided by the Management Board and numerous committees and working groups.
The establishment of the European single market has necessitated representation of the interests of medicines manufacturers to the European Commission and the European Parliament.
In Europe, the Association of the European Self-Medication Industry (AESGP) has adopted this task. AESGP was founded in 1964 in Paris. Since 1990, it is based in Brussels. Beyond the European borders, BAH is involved in the activities of the World Self-Medication Industry (WSMI).
On 7 May 2013 BAH and involved companies founded the association “Initiative medicines for children“ (“Initiative Arzneimittel für Kinder”, IKAM). The aim of the association is to support the safe use of medicines in children. INTEGRITAS, the “Association for fair advertising of remedies” („Verein für lautere Heilmittelwerbung e.V.”), was founded in 1962 on the initiative of BAH. The aim of the association is to preserve fair advertising for medicinal products and related products as an important instrument for fair competition in social market economy, including consumer protection.
By company membership BAH, with its about 400 members, is the leading trade organisation for the pharmaceutical industry in Germany. BAH member companies create about 80,000 jobs in Germany. Due to the high level of professional competence and expert knowledge, BAH is a close contact partner for politicians, authorities and health institutions. On the following pages you will learn more about BAH and its activities.
The permanent changes to European law on medicinal products are a big challenge for pharmaceutical manufacturers. They include legal and procedural provisions concerning pharmacovigilance, i.e. the safety of medicines, or the harmonization of the requirements of the EU Member States concerning market approval or manufacture, all by themselves welcome objectives. However, the necessary efforts to implement them often outweigh their additional benefit.
The most recent revisions of European law on medicinal products related among other areas to pharmacovigilance. However, pharmacovigilance standards in Europe – similar to other sectors of regulation – are already very high. For many stakeholders, further measures require additional efforts including high expenditures of time and money without a perceptible improvement to the safety of medicines. Until several years ago, a risk management plan for medicinal products was only required in exceptional cases. This was changed by the so-called ‘pharmacovigilance package’ of 2010 which also defined the respective regulatory framework conditions. Nowadays, such a plan must be submitted with every application for a marketing authorisation. This even applies to medicinal products with known active substances for which numerous marketing authorisations have already been granted and for which competent authorities have already acknowledged an unremarkable risk profile and so far never required a risk management plan.
The pharmacovigilance package has also placed immediate financial burden on pharmaceutical manufacturers. New pharmacovigilance tasks for the ?European Medicines Agency’ (EMA), the competent authority for market approval of medicinal products in the EU, need to be financed. These tasks include the conduct of EU-wide pharmacovigilance procedures, the evaluation of safety-relevant information from scientific literature, scientific assessments and comprehensive information for the public. They are financed by fees paid by the marketing authorization holders. The fees cover pharmacovigilance activities at the EU level, especially those related to EU-wide assessment procedures such as ‘Post Authorisation Safety Studies’ (PASS), ‘Periodic Safety Update Reports’ (PSUR) and risk assessments. In addition, all marketing authorisation holders must pay an annual fee.
BAH believes that these fees are inappropriate. Particularly for marketing authorisation holders possessing a large product portfolio or products with a low market share, the fee structure is problematic. In the midterm, such high pharmacovigilance fees could lead to the effect that even products with significant benefit for patients are no longer marketed and accessible to medical practitioners and patients.
Example marketing authorisations
The simplification of procedures for obtaining and maintaining marketing authorisations can be particularly difficult to implement. One example being the ‘better regulation’ initiative of the European system for variations to marketing authorisations. Since 2012 all variations to marketing authorisations in Europe must be submitted to competent authorities according to a uniform system, regardless of whether the marketing authorization has been granted via a European or purely national procedure. Implementation of the system in practice is highly complex and susceptible to errors, and constitutes an enormous workload for marketing authorisation holders and representatives from competent authorities.
The requirements concerning Good Manufacturing Practice (GMP) for the manufacture of medicinal products have risen continuously for many years. The increasing complexity of very detailed rules lead to time- and cost-intensive implementing activities, raising the bar especially for small and medium-size enterprises. In the meantime, as well as the actual manufacture of medicines, the manufacture of active substances and other starting materials including excipients and packaging materials, as well as their distribution channels, have been widely regulated. The respective so-called GMP and GDP rules (Good Distribution Practice) have almost doubled during the last decade. This does not only create additional expenditures of time and personnel for the manufacture and testing of medicinal products, the increasing amount of tests and certificates also makes the manufacture of medicinal products more and more expensive.
Further improvements must be proportionate
Medicinal products which may be placed on the European market according to European law fulfil high safety standards. The requirements concerning manufacture and marketing authorisation are enormous. This high level is the result of step-by-step adaptation of the European law for medicinal products to technical and scientific progress. Future changes must be proportionate. They should not rely exclusively on theoretical improvements, but must also have a benefit for the patient. On this basis it must be thoroughly evaluated how much effort can be expected from all parties involved, if the objective is not the improvement of a result but ‘merely’ the design of procedural aspects.
Our members are predominantly comprised of pharmaceutical manufacturers (full members), but also include pharmacists, lawyers, publishing houses and agencies, as well as market research and opinion research institutions (associate members).
You can find a list of our full and associate members here.