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Pharmaceutical law

Sales purchase of pharmaceutical laboratories; pharmaceutical sector companies and clinical trial agreements.

The pharmaceutical law is a set of norms or provisions regulating, directly or indirectly, the pharmaceutical activity in all its aspects. The reason why medicines have their own legislation is because they have a particular nature and idiosyncrasy, inasmuch as they are public goods managed by the State in order to guarantee, regulate and direct the fulfilment of the purpose for which they were intended, which is none other than the Public Health.
We provide our clients with strategic consultancy services, specially focused on the analysis of opportunities and risks derived from the legal framework and the amendments of the same. Practice areas of the pharmaceutical law include:
· Sales purchase of pharmaceutical laboratories
· Obtaining registration with health and industrial authorities
· Legal status of laboratories and wholesalers
· Prices and reimbursements systems
· Supply agreements
· Import and export
· Liability of the product
· Legal procedures as regards pharmacy
· Protecting pharmaceutical inventions

Obtaining registration with health and industrial authorities.

Medicines are regulated throughout all their life cycle. For this reason, they must obtain the corresponding marketing authorization granted by the AEMPS (Spanish Agency for Medicines and Health Products) after evaluating their quality, security and effectiveness, and any variation that takes place shall be likewise authorized and/or notified previously to the AEMPS. Such evaluations enable to ensure the positive benefit-risk relation of the medicines throughout their development in the market. Our firm offers to its clients in this area the legal advice necessary to duly comply with the regulations in force.

Prices and reimbursements system. Supply agreements. Import and export.

There is no doubt that the pharmaceutical sector has undergone constant change. The new biopharmaceutical and health products set up a fascinating scenario, combining the research in genetics and the personalized medicine based on the information. Saving time in the research, registration and marketing of products is basic in order to compete efficiently. The firm Villalba-Coloma-Ankersmit, with extensive experience gained thanks to our clients’ trust, undertakes a continuous legal research in this area and, therefore, feels not only prepared but also considerably experienced to represent and protect our clients’ interests in a number of issues:
· Legal status of laboratories and wholesalers
· Clinical trials
· Prices and reimbursements systems
· Supply, licence, co-promotion and co-marketing agreements
· Labelling, advertising, therapeutic information and medicines promotion
· Liability for product and information default
· Filing for proceedings before the AEMPS or the appropriate Ministry
· Data protection and use of said data for the marketing and recruitment in clinical trials
· Sales purchase of pharmacies

Protection of pharmaceutical inventions. Confidentiality, manufacturing by third parties, clinical process, transfer of registries and distribution.

The patent is an exclusive right granted by the State for a new invention and implies an inventive activity liable to application. The patent is granted by the Spanish Office for Patents and is valid for a limited period of time. In general terms, the confidential commercial information offering a competitive advantage to a business may be considered as a commercial secret. The misappropriation and the unauthorized disclosure or use of said information is deemed to be an unfair practice and a violation of the commercial confidentiality. Depending on the legal system, the protection of the commercial confidentiality is part of the general concept of protection against the competition.

Administrative pharmaceutical and health law. Advice on competition and unfair competition matters.

We advise on all matters affecting pharmaceutical companies in their day-today, ranging from patents, trademarks and unfair competition trough intellectual property rights and know-how, including licencing agreements and co-development agreements. At the same time, we advise on company, commercial and contractual matters. Furthermore, we advise on setting a business activity, obtaining marketing authorizations of products, setting prices and reimbursements from the Administration, and all issues in respect of the manufacturing, advertising, marketing and sale of products. We also act for our clients before the Administration and in all kinds of court proceedings.

Mergers and acquisitions, joint ventures and strategic alliances.

Over the last few years the global pharmaceutical market has been affected by a continuous merger and acquisition movement of businesses from this sector. Synergies of different kinds have been applied, allowing businesses to continue in a highly competitive sector currently divided into two main blocks of American and European businesses together with new competitors from Asia. At Villalba-Coloma-Ankersmit we are prepared to advise our pharmaceutical business clients on acquisitions, mergers with other corporations, or negotiations aimed at implementing strategic commercial alliances.