Pharmaceutical & Medical Law
The technology and innovations surrounding pharmaceutical and medical devices are constantly evolving and changing, while the regulatory environment focuses on budgets, spending, social reimbursement and general healthcare issues. Pharmaceutical & Medical Law is one of our stronger focus areas, and one that we invested significant focus in.
Our Pharmaceutical & Medical Law practice group regularly represents and advices pharmaceutical companies, health care providers, and other key players in the pharma industry. We have an extensive track record of Hungarian and international clients with various matters in the sector.
Client First Approach
We provide solutions for current and anticipated problems through mutual collaboration between our team and yours. We solve and alleviate the legal obstacle.
Our team consists of attorneys trained in several countries, including the United States, Germany, and France.
We are a firm built on cooperation and collaboration not only with our client’s – but internally within our firm.
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Pharmaceutical & Medical Law
We have extensive experience helping clients in the biotechnology and pharmaceutical industries to resolve trade secret and patent infringement matters and developing best practices and strategies for protection of intellectual property. Our pharmaceutical and medical device clients benefit from the intellectual property expertise that members of KNP LAW obtained in the prosecution and defense of innovations, patents, trademarks, and trade names.
In the framework of pharmaceutical patents KNP LAW continuously monitors the compliance with all legal obligations related to patent rights.
Our experience as counsel in product and service liability litigations allows us to assist with strategies for compliance and liability avoidance. KNP LAW also assists pharmaceutical clients in commercial disputes. There is a wide range of matters our team has represented pharmaceutical companies in. These disputes were with vendors, contractors, suppliers, or joint venture partners.
In recent years, our focus has also shifted to the representation of our clients against disputes arising out of challenges which are brought by the Hungarian authorities.
Pharmaceutical Regulatory Matters
We can help clients identify the best regulatory pathway and patent strategy to bring a product to market. We work by drawing up answers to questions related to the eligibility of various approval pathways, labeling, patent certifications, and the scope of various nonpatent exclusivity provisions. Hungary, with its central location in Europe, membership in the EU for over 16 years, and in the Schengen treaty for 12 years, makes the country an ideal environment for the importation and distribution of the pharmaceutical products not only as an entry point to Hungary, but for the EU as well. To elaborate further on these benefits:
- Hungary is ideally located in Central Europe, with easy access by land and air;
- Several international pharmaceutical companies have distribution centers and factories in Hungary from where they supply other European countries and know the ins and outs of the related logistics;
- There are numerous full-scale wholesale pharmaceutical companies who operate in Hungary who also have a manufacturing authorization for the importation of products into the EU;
- Hungary is an ideal choice in terms of both human resources and material conditions. The workforce is well-trained and affordable, and there are a number of storage facilities near Budapest which are suitable for wholesale pharmaceutical distribution activities, including storage; and,
- The Hungarian pharmaceutical authority has an excellent reputation in the EU and specifically with the European Medicine Agency (EMA), which is vital when expanding throughout the EU (through a decentralized or mutual recognition procedure).
Public Procurement of Pharmaceutical Products
In the framework of pharmaceutical law, KNP LAW acts and assists companies as tenderers in public procurement proceedings and other procurements initiated by governmental bodies such as the National Health Insurance Fund of Hungary (NEAK in Hungarian), the National Public Health Center (NNK in Hungarian), and the National Healthcare Service Center (ÁEEK in Hungarian). During the procurements KNP LAW provides full legal services from the beginning of the proceedings which includes review and revisions of the tender documentation, assistance in the usage of the Electronic Public Procurement System (EKR in Hungarian) and we help to make an appropriate offer to fulfill the requirements of the procurement. We accompany our clients during the whole process to conclude and afterwards perform the agreement related to the procurements.
We prepare contracts related to clinical trials for our clients and our team continuously contributes interpretation arising from these clinical trial contracts. Additionally, during our activity, we constantly monitor changes in the legislation related to clinical trials and, in parallel with our monitoring activity, we always try to provide our clients with up-to-date information.
Pharmaceutical Promotion and Advertising
We review and revise all the promotional and non-promotional materials sent by pharmaceutical companies in accordance with Hungarian and European pharmaceutical legislation and ethical regulations in force. Our aim is to facilitate the promotional and advertising activity of our clients and to enable a constantly transparent, ethical, and foreseeable business practice while being open to new and innovative business solutions at the same time.
We not only give pre-qualification on materials, but our team also provides professional advice to clients on individual issues and we liaise with authorities to meet all requirements set out in the authorities’ resolutions.
Marketing and Distribution of Pharmaceutical Products
Our primary goal is to reduce the burden for our clients in all respects. That is why KNP LAW offers customers a complete strategic package for marketing pharmaceutical products. In our strategy package, we provide various alternatives for marketing, and we prepare the documents through the best regulatory pathway in for the specific organization in question. Later, during the marketing authorization process, we act and assist on behalf of our clients and we will compile all the necessary documents for our clients. Furthermore, we give legal advice and assist in the process of the establishment of distribution rights of pharmaceutical companies in the whole process.