Medicinal products and medical devices are heavily regulated in Europe and Germany. In this industry, strategic decisions on how to best place a product on the market and then assess its performance are strongly influenced by complicated legal provisions and industry guidelines. Working around these bureaucratic hurdles can prove difficult without expert legal guidance. At Schlun & Elseven Rechtsanwälte, we are more than capable of providing our clients with the targeted advice, assistance and legal knowledge they need.
Due to our background in the sector of medical law, the dual qualification of our founding partner and the professional expertise of our attorneys, we guarantee optimal representation and full-service consultation to our clients in the German health sector. Our deep industry focus and experience enable us to advise clients on all aspects of the product life cycle – from innovation and development to commercialization and the eventual restarting of the process – and in contentious court proceedings with regulatory authorities.
German Healthcare & Life Sciences – Full-Service Law Firm
Generally, the life sciences and healthcare industries are highly regulated, and legal advice in the field is concerned with medicine and its relationship to the law. It is primarily based on the individual’s fundamental rights and how they balance with the rights of the doctor or health practitioner. Our lawyers act for healthcare clients worldwide, including hospitals and healthcare systems, as well as clinics, health insurers, academic medical centres and retail pharmacies on a wide variety of regulatory, financial and litigation issues all over Germany.
From our offices in Cologne, Aachen and Düsseldorf and conference room facilities around Germany, our lawyers advise our clients in the industry across many legal areas. Whether you require ongoing legal support and partnership with our law firm or require a lawyer for a once-off legal dispute, our lawyers have something to offer you. Contact our firm today to find out more about us.
Commercial Activities & German Contract Law
It is vital to have solid distribution networks with legal protections in place in the life sciences industry. Our lawyers are experienced negotiators, have a deep knowledge of commercial law in Germany, and can provide the necessary guidance for your company’s design of distribution and supply networks. Our team regularly designs and reviews contracts for our clients and can ensure that your contracts fulfil your demands while considering the unique aspects of the industry. Specific agreements our lawyers advise on in the life sciences and healthcare industries include (but are not limited to):
- Clinical Study Agreements,
- Collaboration and License Agreements,
- Manufacturing Agreements,
- Partnership Agreements,
- Research Service Contracts,
- Technology Transfer Agreements.
2020 has shown the value of force majeure clauses in distribution agreements and how and when they can be enforced. Allow our experts to analyse your contracts and distribution and supply agreements.
Corporate Law Concerns: Healthcare & Life Sciences Industries
The corporate lawyers at Schlun & Elseven Rechtsanwälte are available to advise your company on vital legal matters from corporate structures, the restructuring of current companies and on mergers and acquisitions in the industry. When examining corporate models pursued by our clients in the industry, our lawyers provide their specialist expertise with the objectives of the client kept central to matters. This applies to new companies entering the market, as well as to experienced companies aiming to restructure.
In expansions and mergers, our experts advise on how the goals of the company can be achieved in a legally compliant manner, where the requirements of competition law are fulfilled. Mergers and acquisitions in the field of healthcare and life sciences are further complicated by the myriad of regulations within the field.
As negotiators with proven track records and experience, the team at Schlun & Elseven use their industry-specific expertise to oversee your expansion and ensure it takes place successfully. Additionally, our lawyers provide our clients with incisive advice regarding potential breaches of antitrust law by competitors and whether they have the option of pursuing legal action.
Employment Law: Healthcare & Life Sciences Industries
At Schlun & Elseven Rechtsanwälte, our employment lawyers advise and support those in the healthcare and life sciences industries across the board in legal matters. German law provides strong protections for employees which means support from experts in employment law cannot be overlooked. Avoiding legal disputes where possible is important in order to save time and finances as well as for employee morale.
Allow our employment law experts to design and implement suitable policies within the workplace which consider not only the legal requirements but also best-practice procedures within the industry. Such policies include anti-bullying and harassment policies, disciplinary procedures as well as collective bargaining systems.
As certified specialists in the field of employment law, Dr. Thomas Bichat and Mr. Jens Schmidt provide our clients in the healthcare and life sciences industries with excellent assistance and support in employment cases. Should a case reach the labour court, our experts can oversee the case and provide you with leading representation.
Litigation, Arbitration, Negotiation and Dispute Resolution
When legal disputes arise, your company will require lawyers with the required depth of experience and track record. From criminal cases for alleged medical negligence to commercial litigation and civil disputes and enforcement procedures, at Schlun & Elseven Rechtsanwälte, we have the legal professionals for the case. Furthermore, our expert lawyers are available to provide considered legal opinions for our clients on issues concerning contractual clauses and the correct implementation of legislative requirements.
Our lawyers consisting of certified experts and former public prosecutors, assist our clients throughout the process, from initial investigations and preparation to the court case itself and any subsequent appeals. Your business’s long-term and short-term goals will be kept central to our strategy throughout the process.
We advise clients on dispute resolution mechanisms, such as arbitration, mediation, negotiation and, if necessary, litigation.
Our medical negligence lawyers provide private hospitals and other medical practitioners with clear advice concerning practices they can implement to reduce the risk of medical negligence cases arising. Such cases are time-consuming, costly and can hugely impact the professionals involved. Avoiding them at all costs is a priority for those in the medical industry. § 630a (2) BGB outlines that:
(2) Unless agreed otherwise, the treatment must take place according to the medical standards that are generally recognised at the time of the treatment.
Having measures in place to ensure that the practices implemented are of the required standard is of the utmost importance. Allow our lawyers to analyse the measures implemented and the standards expected and then provide your medical practitioners with targeted legal advice.
Should the issue reach the stage where your group needs legal support, our lawyers can also be relied upon to represent you in court.
Whistleblowing in the Healthcare Industry
At Schlun & Elseven Rechtsanwälte, we advise companies and whistleblowers concerning their rights and responsibilities under German law. For companies, it is vital to ensure that internal grievance structures are in place to provide employees and others with the option of using them first. Appropriate mechanisms should be secure, confidential, effective and of the required standards. Not having such systems can lead to those with complaints going public.
Whistleblowing can cause reputational damage to companies, causing them to lose customers and reduce their income. Without appropriate systems, issues of corruption, illegal activity or poor standards cannot be uncovered without controversy.
Whistleblowers should also consider legal advice before taking major action. Whistleblowing without first receiving legal support can leave a whistleblower open to disputes and other difficulties with their employer. Find out what you need to know about German whistleblowing law by contacting our team of lawyers.