The Lawyers and Consultants that make up the Health Law Department have extensive practice and expertise in providing direct legal services to pharmaceutical and biotechnology companies at all stages, we are proud to have constituted a team to match several services that require regulators and hospital units.
The legal advice to the research & development phase of clinical trials, in particular applications for authorization to conduct clinical trials and the establishment of agreements with institutions; test centers and researchers, also including property rights protection industrial, trademarks and patents, besides the monitoring of regulatory procedures necessary to obtain AIM and other licensing, namely production, and to follow up on all regulatory issues that arise, including litigation.
The Department of Health Law has developed a strong differentiation regarding, in particular:
- Medicines prices;
- Personal databases, preparation of documentation for collection and consent, authorization or registration within the CNPD;
- Circulation within the EU, import and export to third countries, applicable standards to parallel imports;
- Price sharing by the State and the establishment of distribution circuits;
- Commercial practices, namely discounts, promotions, events and the regulation of the marketing of medicines in general, whether in the hospital or outpatient market;
- Drug Advertising, which includes specific training (norms and procedures) to marketing teams;
- Competition issues;
- Manufacturing – GMP;
- Clinical Research – Collaboration protocols with entities and researchers;
- Public tenders.
- Licensing business;
- Joint ventures;
We differentiate ourselves by responsiveness and multifaceted team that interacts in total harmony with the various departments of the companies their clients, in pursuit of achieving successfully:
– Best advice on projects of business customers in the area, covering the international component;
– permanent compliance with the legal and ethical rules governing the sectors concerned;
– To ensure the rapid and effective defense in any proceedings involving business customers, whether judicial or arbitral level.
We also ensure, by the specialization gathered in the department, an adequate and specialized response in the following areas:
- Civil and Criminal Liability of Physicians;
- Civil Responsibility (tort law) of the Pharmaceutical Industry;
- Civil Liability of Health Establishments;
- Liability Insurance for damages caused in the exercise of Medicine.
Head: Luís Nobre Guedes