Lawyers and Consultants integrating the health department have a wide experience and specialisation in advising directly pharmaceutical and biotechnology companies in all stages and we are proud of having built a team that meets all market demands, where are included regulatory entities and hospital units.
Our experience comprises assistance in investigation and development stages, of clinical trials, particularly applications for authorisation to conduct clinical trials and the establishment of agreements with institutions and test centres and researchers.
We are also actively involved in the protection of industrial property rights, trademarks and patents and in the follow-up of regulatory procedures (including litigation) necessary to obtain AIM and other licensing and specific partnerships in the area.
The Health Law Department has been developing a strong difference regarding, namely:
Medicines’ prices;
Co-payments by the State and the establishment of distribution channels;
Personal databases, preparing documentation of collection and consent, authorisation or registration before the National Commission on Data Protection;
Circulation within the EU, import and export to third countries, applicable rules to the parallel importation;
Commercial practices, namely discounts, promotions, events, regulation of the marketing of medicines in general, whether in the hospital or outpatient market;
Medicine advertising, which includes specific training (rules and procedures) to marketing teams;
Competition issues;
Manufacturing – GMP;
Clinical Research – Collaboration protocols with entities and researchers;
Commercial licensing;
Joint ventures;
Compliance;
Public tenders;
We differentiate ourselves by responsiveness and multifaceted team that interacts in total harmony with the various departments of our business customers, in pursuit of achieving successfully:
Best advice on projects of business customers in the area, also comprising the international area;
A permanent compliance with the legal and ethical rules governing the sectors concerned;
Ensuring an expedite and effective defence in any proceedings involving business customers, whether judicial or arbitration.
We also ensure, by the specialisation gathered in the department, an adequate and specialised response in the following areas:
Civil and Criminal Liability of Physicians;
Civil Responsibility (tort law) of the Pharmaceutical Industry;
Civil Liability of Health Establishments;
Civil Liability Insurance for damages caused in the exercise of Medicine.