Many are the challenges facing the healthcare environment these days. Parallel to these are the challenges of the pharmaceutical sector, as the impact that demographic, social, technological, epidemiological, and economic changes and challenges have on the former undoubtedly leaves the pharmaceutical sector with the need to contribute to responding to them, safeguarding the continued existence of a public and universal healthcare system, like ours, which allows for evolution not only to provide the best treatment for illness, but to evolve to begin to talk about global health.
Among the challenges posed, some stand out whose impact is undeniable, and their progressive but unstoppable arrival. Such is the advance of aging, chronicity, and dependency; clinical advances, often associated with technological progress, have brought to the forefront – of interest to healthcare professionals, authorities, and patients, but also to the dissemination and media environment – access to therapeutic innovation.
An innovation that sometimes has clinically relevant results and contributions, and other times, not so much. Both will continue to arrive, but all are increasingly accompanied by an enormous economic impact, and therefore carry with them the challenge of seeking efficiency, which makes the system in which we operate sustainable.
It is in this environment that the major regulatory changes in the pharmaceutical field will presumably be addressed and faced imminently. Changes from basic pharmaceutical regulations that will transpose some of the dictates of the European pharmaceutical package, such as the update of the Law on Guarantees and Rational Use of Medicines, or the Royal Decree on Health Technology Assessment, recently published.
Contextualized to respond to the need for regulatory development regarding health technology assessment, in a European working environment that has new regulations in the field and an urgent need not only to make information and communication transparent among all stakeholders, through a predictable and transparent system, both in methodology and temporal horizons, for the decisions and processes of incorporating these health technologies into the National Health System.
In this situation, the new Royal Decree resolves some of the identified needs, but still leaves thorny aspects open, which, although it contemplates them in philosophical terms, leaves them under the protection of methodological guidelines and the subsequent work of the so-called adoption group (positioning group in the draft Royal Decree) that will be created as determined by the norm.
Specifically, the Royal Decree avoids closing in the norm what should be understood by "relevant additional clinical benefit" or by "alternatives of similar clinical benefit", which has an important consequence: the final text improves the comparative framework, but does not shield two concepts that would have been very useful for pricing, financing, and positioning, especially to distinguish between clinically relevant innovation, minor incremental benefit, and equivalent or similar clinical value therapeutic alternatives, aspects on which the tension of the process is concentrated, and which would be more solidly protected if, even incorporating the "relative position of the health technology" it does not define that positioning consists of determining its concrete place in therapeutics, prevention, or diagnosis, nor does it expressly require its location to be specified with respect to the set of available options in terms such as: first line, preferred alternative, equivalent alternative, use restricted to subgroups, conditional use, standard substitution, non-preferred, etc. Perhaps the change of name we alluded to (from positioning group to adoption group) has to do with this new approach.
Another of the thorny issues, the one linked to transparency, seems to be considered asymmetrically. The Royal Decree incorporates the obligation to provide information on public or non-profit financing and on production and development costs necessary for economic analysis. However, it does not fully incorporate the proposal for robust transparency on reliable production, research, and development costs, with a clear breakdown between own, private, public, and non-profit financing, nor does it expressly link this information to the setting of a fair price.
It remains as information required for economic evaluation and eventually for pricing and financing procedures. Therefore, transparency is advanced, at least in dialogue. Whether it will be sufficient to resolve the needs, or if, on the contrary, the approach will pose a limitation to the progressive flexibility and adaptability that the financing system would need to acquire, are questions for which no one has the answer.
It does not fully incorporate the proposal for robust transparency on reliable production, research, and development costs
However, these changes aim to provide solutions to many of the previously raised challenges, and to update the basic pharmaceutical regulations to adapt to the current social, therapeutic, and technological reality. At this point, I believe it is worth making an important reflection. And that is that, beyond adapting, regulatory developments have two enormous additional responsibilities.
On the one hand, they must foresee and propose solutions to the needs of the immediate future in the pharmaceutical field, which undoubtedly has economic sustainability and the need to facilitate patient access to therapeutic advances among its greatest urgencies; and on the other hand, to recognize and value what has been rigorously built by its professionals and to advance from the detected inefficiencies, without deconstructing what has been valuable in what has been done.
The new times pose values such as transparency, technical scientific rigor, interdisciplinarity and participation of professionals, and the voice of patients as non-negotiable, the latter aspects that the Royal Decree seems to consider. However, whether the formula proposed by the Royal Decree, as approved, answers these questions will be shown by the passage of time.
It only remains to express the wish that the voice of the professionals involved will be taken into consideration
In this context, as the Spanish Society of Hospital Pharmacy (SEFH), it is a priority for us, aligned with these policies, both nationally and internationally, to continue contributing to the improvement of decision-making regarding the rational use of medicines and to continue contributing, through the vast knowledge of many of the professionals who make up our society, to the process of drug evaluation.
Many are therefore the challenges, as many as the expectations. It only remains to express the desire that the voice of the professionals involved be taken into consideration to contribute to aligning objectives and results, for the benefit of patients, the system, and society.
about the author:
Cecilia Martínez Fernández-Llamazares is president of the Spanish Society of Hospital Pharmacy.