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Market opportunities and challenges

Due to the complexity of Life Sciences Law, the diverse business opportunities in the Life Sciences Industry face great challenges. In addition to traditional business law, there are numerous special laws to be observed.

 

In this publication we provide an overview of the most important areas of law, starting with Pharma­ceutical and Food Law, Cosmetics and Consumer Goods Law as well as Chemicals Legislation and Waste and Packaging Law. We offer a wide range of topics that are of importance for the Life Sciences Sector and in particular address current developments and issues.

 

The following articles show how the individual areas of law are interwoven and basically follow the same leitmotif: The compatibility of economic interests with the protection of health, consumers, the environment and to guarantee fair competition. We attach particular importance to the section on Internationalisation. A look beyond the National Borders shows that we are dealing with basically the same questions and problems worldwide in the field of Life Sciences. However, the solutions found in the relevant legislations are sometimes very different. Knowing the law and these differences is, however, a basic prerequisite for successfully embark­ing on a new path.

Interview with Dr. Klaus

Pharmaceutical Law
The high density of regulations is a constant challenge for companies and investors in the pharmaceutical industry: The legal requirements for the development and production as well as the distribution, advertising and monitoring of medicinal products drugs and medical devices are demanding. The complexity of pharma­ceutical law results not least from the fact that it is an interdisciplinary cross-sectional matter: In addition to regulatory requirements, numerous regulations of conventional business law must also be observed, e.g. antitrust and competition law, patent and trademark law, foreign trade law, criminal and administrative offence law, and data protection.

Food Law
Food law is characterized by constant development and comprises a wide variety of sector-specific provisions. In addition, there are numerous interfaces with traditional commercial law (e.g. antitrust and competition law, intellectual property law, criminal and regulatory offences law). Companies operating in the food industry must therefore observe a multitude of legal requirements, starting with the product idea and continuing through the production and marketing of their food, feed and food contact materials, and closely follow developments in legislation and case law to ensure the necessary compliance.

Cosmetics and Consumer Goods Law
Cosmetics and other consumer products (e.g. textiles, toys, furniture, detergents and cleaning agents) come into direct contact with humans. The laws on cosmetics and consumer goods therefore place high demands on their harmlessness to health. In order to enable consumers to make informed choices, additional requirements are placed on labelling and advertising. This legal framework is rounded off by strict market surveillance rules. Safety assessments, the examination of advertising claims as well as the decision whether recalls are actually necessary in case of product defects constantly put the business activities of the companies concerned to the test.

Chemicals legislation
Chemical substances are found in almost all products, which is why chemicals legislation has an impact on most companies, especially in the life science sector. They must therefore be aware of the numerous require­ments and be able to apply them correctly when manufacturing, using, importing or trading in chemical substances and mixtures. The cornerstones of European chemicals legislation are the REACH and CLP Regulations. There are also regulations for special areas of application, for instance for cosmetic products, biocides, plant protection products and fertilizers. The body of regulations on chemicals is therefore complex. In addition to specialization, a sound knowledge of European law and an interdisciplinary approach are necessary to master chemicals legislation.

Waste and Packaging Law
The waste law is characterized by a multitude of European and national legal acts. The cornerstone is the Waste Framework Directive, which in Germany is implemented in the Waste Management and Product Recycling Act (Kreislaufwirtschaftsgesetz). In addition, there are regulations for specific product waste, i.e. in the German Packaging Act (Verpackungsgesetz). The core element is the so-called waste hierarchy: waste prevention, reuse, recycling, other recovery, disposal. Waste should therefore primarily be avoided or used effectively as raw materials. The New Circular Economy Action Plan as part of the Green Deal also aims to reduce the EU’s consumption footprint. All companies that potentially generate waste are bound by waste legislation. Sustainable waste management and the establishment of environmental compliance management systems therefore play a central role, especially in the Life Science Industry.

Internationalisation
The Life Science Industry is globally networked, with business partners worldwide and target markets with a wide variety of legal requirements for products and services. Therefore, not only intercultural key competencies are required, but also knowledge of international law and with regard to sector-specific legal requirements in the respective marketing country. While many areas of law relevant to the Life Science Industry are harmonized within the EU, very different rules may exist in third countries. These rules must be known and correctly applied if complaints with possible bans and sanctions are to be avoided.
​published on 11 November 2020

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