Want to know more about regulatory reforms in Spain? Read on! Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
At present, the main proposals for regulatory reform are referred to the Spanish regulations on:
- price and reimbursement of medicinal products and medical devices,
- advertising of medicinal products and medical devices, and
- non-interventional studies with medicinal products.
2. When are they likely to come into force?
The process for approval of the above mentioned proposals is still ongoing. Considering the current political situation in Spain (recent elections at a national and, in some cases, regional level), it is difficult to predict when such proposals will be approved and how the final texts of the same will be.