Environmental, Sustainability & Supply Chain Scrutiny
Sustainability in the Life Sciences sector
The development of a climate-neutral healthcare industry is one of the EU’s most important current goals and compliance with ESG standards will be a crucial factor for innovative healthcare companies. Establishing sustainability standards in healthcare companies requires in-depth knowledge of both ESG standards and the specific regulatory requirements for pharmaceuticals and medical devices. Thanks to our specialisation in the life sciences and healthcare sector as well as in ESG regulations, we can support our clients in taking a pioneering role in implementing ESG standards.
Environmental & sustainability issues will also gain increased importance in the context of approval and conformity assessment procedures in the future, on which we advise clients on an ongoing basis. Also in other areas of the product cycle, the life sciences industry has also discovered the area as a differentiator following the digitalization topics of recent years, be it in the area of environmentally friendly manufacturing processes, replacement of chemical substances with ecological substances (keyword: Green Chemistry) or take-back programs for empty primary packaging. Such voluntary and manufacturer-organized take-back programs help to optimize the disposal of pharmaceuticals or medical devices and reduce environmental impact by enabling users to return unneeded or expired medicines. In order to successfully implement a take-back program, for example, companies must take into account the diverse and complex legal framework with regard to the return and disposal of medicinal products or medical devices. We advise on all regulatory aspects, including waste management issues.
In the area of ESG, we advise our clients in particular in relation to the following:
- Continuous information on ESG-relevant regulations and new legislative procedures
- ESG risk analysis and risk management
- Draft and implementation of corporate ESG codes
- Third party due diligence systems
- Administrative, judicial and extrajudicial disputes at national and international level
- Corporate sustainability reporting (CSRD)
- Legal support of complex ESG planning and approval procedures
Environmental and sustainability advertising and promotion
Such environment-related initiatives by companies are increasingly to be communicated as part of external relations and promotion. “Climate neutral,” “sustainable packaging,” “recyclable” – when sustainability and environmental protection are integrated into advertising, questions quickly arise that companies in the pharmaceutical and medical technology industries were not usually confronted with before: What are the basics and standards for such advertising? What are the special requirements in connection with pharmaceuticals and medical devices? In addition, the EU Commission intends to create uniform EU regulations for environmental claims with the so-called “Green Claims Directive”. What does this mean for companies? We advise companies on all these topics, both on a project basis and on an ongoing basis in their operational business.
Supply Chain Scrutiny
Fulfilling the extensive obligations of the German Supply Chain Sourcing Obligations Act (Lieferkettensorgfaltspflichtengesetz – LkSG) poses major challenges for the pharmaceutical and medical device industry in practice and represents a further component of our range of legal consulting services. This is because not only large pharmaceutical and medical device companies are directly affected by the new law, but also indirectly medium-sized companies and German sales subsidiaries, since customers (other stakeholders such as hospitals or wholesalers) sometimes demand extensive self-declarations or contractual regulations from them, in which, for example, far-reaching risk assessments, supplier assurances, auditing rights and reporting are required. The obligations arising from the LkSG also already play a significant role in tenders issued by health insurance funds. We will be happy to advise you on the implementation of the LkSG if your company is directly affected, but also on the extent to which the LkSG obligations for direct and indirect suppliers actually go and which measures are sensible and effective. Our services include, inter alia:
- Advice on the implementation of the Supply Chain Due Diligence Act (LkSG), in particular identification of the exact obligations (direct or indirect applicability), gap analysis, introduction of a formal system, draft company statements, supplier letters, etc.
- Third party due diligence systems
- Contractual design of supply chains and distribution structures
The new Whistleblower Protection Act came into force on 2 July 2023. Among other things, it obliges companies with 50 employees or more to set up a whistleblower system with an internal reporting centre. Whistleblower protection is an important part of your company’s compliance system. We will be happy to advise you on the implementation of your obligations and on individual legal questions. For example, we advise on the setting up of whistleblowing standards, can check whether the system you have implemented or are planning to implement complies with the requirements of the Whistleblower Protection Act and advise on the handling of whistleblowing investigations.