Healthcare and Life Sciences

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Marianna Holland
5 years ago
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1 Healthcare and Life Sciences

2 Introduction Uría Menéndez is an independent law firm that was founded in Madrid in 1946 by Professor Rodrigo Uría González. We currently have seventeen offices in Spain, Portugal, where we operate as Uría Menéndez - Proença de Carvalho, and major cities in Europe, the Americas and Asia. We advise on Spanish, Portuguese and EU law in business-related matters and assist our clients in their international transactions through our network of offices and our close links with prestigious law firms around the world. After almost two decades in Latin America, we have further strengthened our ties to the region with the creation of the first major Ibero-American law firm Philippi, Prietocarrizosa, Ferrero DU & Uría (PPU). PPU was set up in January 2015 following the merger of Philippi (Chile) and Prietocarrizosa (Colombia) and grew in January 2016 with the incorporation of the Peruvian law firms Ferrero Abogados and Delmar Ugarte. PPU now has more than 350 lawyers and offices in Chile (Santiago), Colombia (Bogotá and Barranquilla) and Peru (Lima). We are one of the most prestigious law firms in Continental Europe and have adhered at all times to our core principles: rigorous analysis of the law, professional services of the highest quality and long-lasting relationships with clients, capacity for innovation and honesty, decency and strict compliance with high ethical and professional standards; in a nutshell, we strive to excel at all levels. Rodrigo Uría Meruéndano 02

3 We are one of the few leading Iberian commercial law firms that has a specific Healthcare and Life Sciences. We have set up this area to meet our clients demand for specialist advice. The members of our Healthcare and Life Sciences Area advise on all areas of the pharmaceutical, biotechnology, health, food and cosmetics industries, including regulatory, contractual, competition, intellectual property and M&A matters. We offer our clients expert advice of the highest quality. We advise both national and international clients on the start-up of their activities in Spain and Portugal, the launch of new products, the expansion of their activities through strategic alliances with other market operators, protecting their products (e.g., intellectual property rights), and on the licensing of products for development, manufacturing and marketing purposes whether licensors or licensees. Our services also include advice on the marketing of pharmaceutical products and medical devices, including price setting, the inclusion (or exclusion) of pharmaceutical products and medical devices in the reimbursement system, and the creation of direct and indirect wholesale policies. We represent our clients in civil and administrative litigation proceedings, appealing involving competitors (e.g., unfair competition, liability and contractual claims) and public authorities (appeals against measures or regulations adopted by the authorities). We advise on the design of promotional and advertising strategies and on the implementation and control of anti-corruption compliance programmes, something which is particularly important in an industry that works very closely with governmental officers. In essence, our aim is to accompany our clients at every stage and in all aspects of their activity. Our commitment to these industries has led us become involved in the most important developments in this sector. For example, our role in defending the legality of new wholesale policies adopted by pharmaceutical companies is widely recognised as having been very important for the restructuring of the pharmaceutical distribution sector, as has our advice on the design of strategies related to government policies aimed to reduce pharmaceutical expenditure. 03

4 The members of our Healthcare and Life Sciences Area are based in our Madrid, Barcelona and Lisbon offices. There are currently six partners, two counsels, four senior associates and more than twenty associates. A large number of lawyers from our Public Law, Litigation and Arbitration and Competition Practice Areas are also health and food specialists, which allows us to create expert ad hoc working teams. 04

5 Healthcare and Life Sciences Our specialist in-depth knowledge of the legislation applicable to the pharmaceutical, health, cosmetics and food industries means that we can fully understand and meet our clients concerns and needs. We offer a high quality and efficient service. Our Healthcare and Life Sciences Area is renowned for its knowledge of the sector and for its experience in restructuring commercialisation models for medicines and medical devices, protecting client interests in matters related to financing and prices, and advising on strategic alliances within the sector. Our experience includes: General advice on the legislation applicable to the health, pharmaceutical, biotechnology, cosmetics and food industries M&A of pharmaceutical laboratories, medical device companies and cosmetics and food sector companies Joint venture, co-development, licensing, co-marketing, co-promotion and exclusive promotion contracts Reimbursement and price regulation of medicines and medical devices. Advice on restrictions to the prescription, dispensation and financing of medicines Supply, distribution and agency contracts. Restructuring of commercialisation models. Market supply and parallel trade Direct sales to pharmacies and sales to hospitals (public tenders) Collection of payments for medicines and medical devices from public authorities: claims for principal or interest and transfers of credits held against public authorities Labelling, advertising and promotion of medicines, medical devices, cosmetics and foodstuffs; compliance with legislation and professional codes of conduct and ethics These excellent professionals know the sector and its legislation. They are exceptional and very capable of offering added-value advice. Chambers Europe 05

6 Promotional compliance audits Clinical trials: contracts and liability Protection of pharmaceutical patents Product liability Proceedings before the Spanish Ministry of Health, the Spanish Medicines and Medical Devices Agency, the Surveillance Unit of the Spanish Pharmaceutical Industry Association (Farmaindustria) and the Complaints Committee of the Spanish Advertising Self-Regulation Organisation (Autocontrol). Also, judicial (either contentious-administrative or civil) proceedings Removal, storage and use of human organs and tissues and their commercial distribution Clinical responsibility and liability risks for healthcare facilities and professionals Functional foods and borderline products It advises a large number of pharma and biotech clients, who appreciate the strong industry focus of the teams in Barcelona and Madrid. Chambers Europe Recent highlights include advising innovative pharmaceutical companies on the new cost-cutting measure implemented by the government. Chambers Europe 06

the SPD company Dr Clive Simon, Principal, The SPD Company.

the SPD company Dr Clive Simon, Principal, The SPD Company. the SPD company With decades of local and international experience at the coalface, The SPD Company s specialists have built a solid repertoire of in-depth technical knowledge within the highly-regulated