Pharmaceutical & Life Sciences Law
Pharmaceutical & Life Sciences 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 more substantial focus areas.
Our Pharmaceutical & Medical Law practice group regularly represents and advises pharmaceutical companies, healthcare 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.
More about this service
We have extensive experience helping clients in the biotechnology and pharmaceutical industries resolve trade secret and patent infringement matters and develop best practices and strategies for protecting 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 compliance with all legal obligations related to patent rights.
Our experience as counsel in product and service liability litigations allows us to assist with compliance and liability avoidance strategies. KNP LAW also assists pharmaceutical clients in commercial disputes. Our team has represented pharmaceutical companies in a wide range of matters. 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 brought by the Hungarian authorities.
Pharmaceutical Regulatory Matters
Hungary, with its central location in Europe, and membership in the EU and the Schengen Area for several years, makes the country an ideal environment for importing and distributing pharmaceutical products not only as an entry point to Hungary but for the EU as well. 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. To elaborate further on these benefits:
- Hungary is ideally located in Central Europe, with easy access by land, water (River Danube), and air;
- Several international pharmaceutical companies have distribution centers and production sites in Hungary from where they supply other European countries and know the ins and outs of the related logistics;
- numerous full-scale wholesale pharmaceutical companies operate in Hungary that also have 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 several storage facilities near Budapest are suitable for wholesale pharmaceutical distribution activities, including storage and product release; and,
- The Hungarian pharmaceutical authority (OGYEI in Hungarian) 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 Hospital Directorate (OKFŐ in Hungarian). During the procurements, KNP LAW provides complete legal services from the beginning of the proceedings, including reviewing and revising the tender documentation and assisting in using the Electronic Public Procurement System (EKR in Hungarian). We also help make an appropriate offer to fulfill the procurement requirements. We accompany our clients during the process to conclude and afterward perform the agreement related to the procurements.
We prepare contracts related to clinical trials for our clients, and our team continuously contributes interpretation from these clinical trial contracts. Additionally, during our activity, we constantly monitor changes in the legislation related to clinical trials. In parallel with our monitoring activity, we always 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. We aim to facilitate our clients' promotional and advertising activity and enable a constantly transparent, ethical, and foreseeable business practice while simultaneously being open to new and innovative business solutions.
We not only give pre-qualification on materials, but our team also provides professional advice to clients on individual issues. We also 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. KNP LAW offers customers a 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 for the 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.
Do you handle commercial communication and advertising issues related to pharmaceuticals?
Yes, we handle all pharmaceutical advertising issues.
Do you assist with regulatory issues related to pharmaceuticals and medical devices?
Yes, we handle regulatory issues and licensing for pharmaceuticals and medical devices.
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 clients – but internally within our firm.
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