The legislation governing medicinal products and medical devices is extensive and complex.

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International Trade, Regulatory and Government Affairs

The core of our legal services is our knowledge of all aspects of product and company life cycles, and our vast industry knowledge. At DLA Piper, we have a special focus on the life sciences industry with lawyers with complementary professional expertise who can advise on all essential issues relating to medicinal products, medical devices as well as food and feed. We work across borders, and thanks to our global network we are able to provide expert legal advice.

Medicinal products and medical devices

The legislation governing medicinal products and medical devices is extensive and complex. The core of our legal services is our knowledge of all aspects of product and company life cycles, and our vast industry knowledge enables us to advise all types of companies.

Market access and product licences

The process of obtaining a licence to sell medicinal and other products can be prolonged and difficult and require extensive data. We have in-depth knowledge of the legislation in this area, and we advise on all legal issues arising in connection with data protection, access to public administration files, etc. We also have broad experience of negotiating with government agencies and other public authorities and of how to handle regulatory issues relating to medical devices.

Marketing and advertising

We advise on the special issues relating to the marketing and advertising of medicinal products and medical devices. We have vast experience of ensuring that the material and marketing efforts of companies comply with the statutory requirements and guidelines for this industry.

Research, development and clinical trials

DLA Piper Denmark has vast experience with the regulatory framework concerning R&D and clinical trials, and the contractual needs between private and public partnerships, such as Sponsor-Investigator collaborations.

Compliance programs - risk management and crisis response

We have extensive experience in advising on and providing tailor-made compliance programs as well as emergency management for companies in both the pharmaceutical and medical devices industries. We understand the needs in these specific industries and are intimately familiar with the particular risks that must be accommodated.

Product liability and dispute resolution

Product liability is becoming increasingly important for companies within the pharmaceutical and medical devices industries. DLA Piper Denmark provides advice on all aspects of product liability. We also assist in preventing product liability cases through limitation of liability and warnings. Our insurance department has a wealth of experience within product liability insurances.

We are well-known and ranked for our capabilities within dispute resolution, including mediation and arbitration. Our Life Science team members have conducted several cases before the Danish courts, including the Danish Supreme Court, and the Court of Justice of the European Union.

Intellectual property

There are few other industries where intellectual property rights play such an important role. We know how important it is for a company to obtain and protect its intellectual property rights, and we appreciate the importance of protecting the company's exclusive rights. We also have special experience of litigating disputes involving intellectual property rights.

Corporate/M&A

DLA Piper Denmark’s corporate M&A team has many years of experience with assisting life science companies and possesses extensive expertise and specialized knowledge within the life science sector making our team well-resourced to handle any legal matter pertaining to this industry.

We have the capabilities and capacity to carry out any legal assignment concerning the sale and purchase of companies at every level and across all fields of the life science industry covering all aspects of the due diligence process, negotiation of transaction documents, and more. Additionally, our team assists with the incorporation of entities, registration with relevant public authorities and have significant experience with all legal aspects of placing investments in the industry. We also have extensive experience in dealing with the legal aspects of the restructuring of groups and have assisted in many large-scale restructuring processes.

Enhancing these strengths, our team is well-versed in tax laws, capital markets, finance, and conducting corporate investigations. This ensures that we provide legal support tailored to the unique needs of the life science sector.

Competition law

Our competition law team has extensive experience of advising companies in this industry. Often, the markets involved are concentrated, which increases the risk of problems relating to competition law. Our expertise covers all areas relating to competition law, including merger control, anti-competitive agreements, abuse of dominant position as well as state aid and problems at the intersection between IPR and competition law.

Public procurement law

Public procurement legislation plays an essential role for companies selling medicinal products or medical devices. Medical devices, in particular, are mostly sold to public-sector customers, which are required to comply with the public procurement rules. We have extensive experience of advising companies during the tendering process and representing them in connection with complaints.

Dispute resolution

We are top ranked in the area of dispute resolution, including arbitration and mediation. On several occasions, our life sciences team has represented clients before the Danish courts, including the Supreme Court and the European Court of Justice.

Food and feed

The legislation governing food is intense and constantly changing. Our life sciences team has the necessary expertise and experience to advise companies on all aspects of food law, including research, compliance of manufacturers and distributors, import/export and marketing.

The food industry is highly regulated by EU law, but Denmark has special rules in several areas. We have vast experience of handling the uncertainty this may cause, and we are in dialogue with the public authorities on the problems faced by companies.

The composition of our specialist team also enables us to advise companies on all derivative problems, e.g. product liability, tax and IPR. Our lawyers are among the best in the areas of litigation and arbitration, and we have vast experience of representing our clients in cases not only before the Danish courts but also before international courts and institutions, including the European Court of Justice and the European Commission.

Labelling, marketing and health claims

In recent years, food manufacturing companies have increasingly been allowed to market their products by means of health claims. We advise both Danish and foreign clients on all aspects relating to the packaging, labelling and marketing of products, including sale and marketing on the Internet.

Requirements for food ingredients

The requirements for food ingredients are heavily regulated, and this area is characterised by a large number of special rules, including restrictions which are applicable only in Denmark. We advise Danish and foreign clients on the use of additives, nutrients, GMO products, novel food, animal ingredients and plant components and on other restrictions for ingredients, such as processing and chemical contaminants, e.g. pesticide residues.

Self-monitoring, health inspections, crisis management and withdrawals

We help companies establish self-monitoring programmes and advise them on how to handle health inspections. We have vast experience of dealing with improvement notices, prohibition orders and complaints. If sanctions are imposed by public authorities, we can help companies ensure that the sanction imposed is the least intrusive. We always keep in mind that non-compliance may result in substantial financial losses and damage to the company's reputation. For that reason, the dialogue with the public authorities is paramount to dealing with the challenges faced by our clients.

Dietary supplements and nutrition for special target groups

The food industry produces a large number of niche products. Our life sciences team advises on the sale and marketing of dietary supplements and products for special target groups, e.g. food for special medicinal purposes and sports nutrition products.

Cannabis industry

DLA Piper is one of the leading advisors regarding the nascent cannabis industry. We are aware of the uncertainties within the industry and is prepared to help clients navigate these.

We provide our clients with advice on start-ups, private and public fundraisings, acquisition, and post-merger and we cover the range of corporate, IP, technology, employment and regulatory.

We advise operators at each stage in the supply chain, including matters of liability and labelling as well as packaging and application for quality control certifications as to ensure that the required minimum standards are met.

We also assist companies in evaluating and preparing expansion strategies, including joint ventures, mergers, and acquisitions and, if appropriate, public equity investment.

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