The development, approval, manufacture, distribution and, not least, dispensation of medicines are shaped by a variety of regulations. The European Union and national legislators are constantly making their contribution to the growing volume of regulations with new developments. Safety and quality requirements are constantly increasing. This is not always an easy thing for those involved to deal with, especially with national and European supervisory authorities placing great emphasis on such regulations.
Pharmacists are constantly facing new challenges. It is not just the spatial requirements for the authorisation to operate a pharmacy that are continually being modified; the permitted range, possible services and advertising options are also subject to constant change. This also involves issues resulting from the position of the pharmacy as a cost interface between service providers and the pharmaceutical industry: Retaxierung (re-appraisal of prescription billing), discount contracts, aut-idem, reference price groups.
Unlike normal consumer goods, medicines and other medicinal products are not harmless products. Whether it be in the prescription or over-the-counter sector, contra-indications, reciprocal effects, side effects or incorrect dosage can lead to health risks. Advertising that essentially aims at encouraging use of a certain product may be at odds with these risks. Medicinal product advertising law is intended to protect the consumer from impermissible advertising. We will support you in this complex matter and help you to bring your interests and goals into harmony with provisions under medicinal product advertising law.
The situation for marketing foodstuffs has changed with the introduction of the European Single Market. The number of foods on offer has increased significantly. This is due to the fact that culinary variety is no longer allowed to be restricted by national regulations. The principle of origin applies here: products that can be legally sold in one member state of the European Union can also be marketed in the other member states.
Even if marketing medical products is subject to simpler obstacles than the sale of medicines, the existing regulations are not to be underestimated. Problems often occur particularly in the sale and advertising of medical products.
Cosmetic products are subject to extensive legal frameworks and regular changes in terms of their composition, manufacture, labelling, advertising, sale and monitoring. This is partly due to consumer safety. In addition, there are often issues regarding the differentiation of the product from, for example, medicinal products, due to confusion about composition.
One key area of focus in the work of DIEKMANN Rechtsanwälte is pesticide law. Pesticides face a lot of tension in terms of public perception. On the one hand, pesticides are required to ensure a consistent supply of low-price, high-quality products over increasingly small agricultural areas. On the other, people see pesticides as something threatening, as they interfere with the ecosystem.
Competition law, by means of the German fair trade act (UWG), prohibits unfair business dealings. This act sets out banned conduct, for example, deception. In addition, it incorporates standards that govern market behaviour, such as individual provisions of the German medicines act (AMG). This makes it clear that in order to review and advise on advertising as well as to take action against violations of competition law, what is required is sound knowledge of both UWG and specific areas of the relevant standards governing market behaviour. We can provide you with this
Classic understanding of trade marks and other commercial designations has changed. Trade marks and other commercial designations have long moved away from their classic function of simply identifying the good or service of a company or the company itself, and are now one of the key factors in a company's image building. The advertising value associated with well-known trade marks and commercial designations as well as the marketing effort involved in developing and establishing new product designations, logos or company names contribute considerably to the success of a product and therefore the company itself.
Copyright often forms the starting point for immaterial value creation. It gives its holder exclusivity rights and, alongside works such as music, language (computer programs!), literature and the visual arts, for example, protects creative outputs that, as such, do not feature sufficient individual form, e.g. those of a practising artist or a producer of sound-carrying media (known as ancillary copyrights).
The provisions of Community law are of great importance for legal consulting in our areas of activity. This is due to the realisation and implementation situation: because Community law takes precedence over national law, it is essential that the question of conformity with Community law be verified at each stage, if required by calling on the European Court of Justice – whether it be through contract violation proceedings initiated with the European Commission by means of a complaint or through an order for reference prompted as part of court proceedings.
Under certain conditions, you are entitled to up to 600 euros of compensation from the airline under EU Directive 261/2004, which is aimed at protecting consumers. In our experience, airlines often try to get out of these payment obligations by shunning or contesting your claim. Without legal assistance, it is often almost impossible to enforce your payment claims.
DIEKMANN Rechtsanwälte can help you get what's due to you!