What major regulatory trends are emerging in Europe and in Spain? As one of the founding partners of a law firm focused uniquely on the life sciences industry, Faus & Moliner Abogados, Jordi Faus has been confronting the industry’s unique legal issues for over 25 years. In a recent PharmaBoardroom interview, he identifies five European, and more specifically, Spanish, regulatory trends.
Readiness for Regulatory Reform
From the perspective of his in-depth understanding of the industry and its regulatory, social and political environment, as well as the legal implications involved, Faus pinpoints the willingness of stakeholders in Europe to evolve the regulatory environment. “Regulators, the industry and people in charge of the public healthcare systems are all pushing for regulatory innovation,” he says.
In Spain, there has also been a move towards reform and Faus identifies the Spanish Ministry of Health’s current work on amendments to address market access, pricing and reimbursement issues as a positive step: “The mere fact of talking about these matters has already resulted in some procedural improvements in Spain,” he says.
An important trend Faus identifies is the increasing importance of patient involvement in the drug development and registration process and how the push for access must be balanced with the security of new drugs and the restrictions of public finance. “The big challenge in today’s world is how to harmonise the pressure for access from patients – who demand that new drugs are available as soon as they come out– and the uncertainty of new products, along with the impact on a country’s finances.”
The big challenge in today’s world is how to harmonise the pressure for access from patients and the uncertainty of new products, along with the impact on a country’s finances
Jordi Faus, Faus & Moliner Abogados
The rise in patient awareness also implies a series of legal issues, says Faus: “The position of patients is growing in importance, demanding what we call individual patient rights. Like it or not, we will have a debate about this because, in all modern constitutions, the right to life is considered a fundamental right. What does that mean? Does it mean that you have a right to exist, or does it mean that you have a right to a treatment that will save your life? For public systems, does the system have the obligation to pay for those treatments?”
These rights, according to Faus, have already been acknowledged to some degree in Spain. “There are precedents that recognise the right of patients to have access to certain drugs based on the protection of fundamental rights, which may be enforced via special, faster procedures,” he comments.
“Market access decisions have become increasingly complex,” says Faus, with risk-sharing becoming a major tendency: “The industry is now facing situations where payers want to have risk-sharing mechanisms, volume-based contracts or deferred payment systems.”
In addition, Faus notes that the relationships between companies, payers and hospitals have evolved, giving rise to a number of legal considerations. “Nowadays, companies understand that they may add value by collaborating in the diagnosis of diseases, the follow up of patients, the gathering of data, keeping patients away from hospitals, and so on. This, of course, raises many legal issues.”
Another hot topic for Faus is price transparency and whether companies and authorities should share all price-related information with the public. “We have heard a lot about [price transparency] in the context of the European Union’s vaccine contracts during the pandemic; it is an area where you must find a balance between transparency and negotiation power. It is logical and fair that the public wants to know how the government is spending its money, so the system must give information to the public, but I am not sure if it is necessary to go into specific details if this harms the negotiation power of the authorities,” he says.
Regulatory Impact on Spain’s Clinical Trials
For Faus, Spain has become an attractive location for clinical trials thanks not only to the quality of its healthcare system, but also the evolution of its regulatory environment and the efforts to centralise approvals within the country’s highly regionalized system. “The regulatory tools have helped because we now have a system where you can have one ethics committee approval that is valid throughout the whole country. Regional authorities have been active in developing reasonable templates for agreements. We do plenty of work in clinical trial agreements and have seen a positive evolution.”