The pharmaceutical industry is responsible for the development, production and marketing of medication and its importance as a global sector is indisputable and cannot be underestimated.
The main aim of the industry is to develop and provide medicines that prevent or cure diseases and help maintain health. As such, it is an industry that directly affects the lives of everyone around the world and has several international regulatory bodies to monitor the safety, quality and pricing of medication, together with patent applications and registrations.
In Romania, medicines are subject to a variety of laws and regulations issued by various authorities including the Romanian Ministry of Health, the National Agency for Medicines and Medical Devices and the National Health Insurance House. These authorities have a role in relation to the patenting, testing and marketing of medicines, especially prescription-only medicines.
While most observers predict a robust expansion of the Romanian pharmaceutical market in comparison with its fellow EU member states, there are caveats to this. Issues over pricing, claw back taxes and the uncertainty about financing of the healthcare system are likely to become more prominent over the coming months and years and this is may create an increasingly negative outlook for the market.
Our Relevant Experience
- Advising many innovative international pharmaceutical companies on strategic issues related to pricing and reimbursement in light of the multiple changes to pricing legislation.
- Advising various innovative international pharmaceutical companies in relation to regulations governing clinical trials, including drafting and revising different agreements and any supporting documents required in the performance of clinical trials.
- Advising several international pharmaceutical companies in relation to the transparency obligations and disclosure procedure required under Romanian legislation and the pharmaceutical industry disclosure codes, including revising all documents to be submitted to the relevant authorities.
- Advising and assisting large international pharmaceutical companies in relation to various internal investigations, including performing legal and forensic investigations, revision of information, interviewing employees, drafting investigation reports, assisting with revising and implementing internal standard operating procedures and providing legal and compliance training for employees.
- Advising and assisting various large international pharmaceutical companies on strategic issues relating to the healthcare assessment procedure and during the negotiation of cost-volume/cost-volume-result agreements.
- Advising and assisting various large international pharmaceutical companies on patient support programmes, national therapeutic programmes, outpatient healthcare, distribution of medicines outside the traditional distribution chains and administration with professional healthcare support.