Technology reaches all areas, and the health sector was not going to be any less. It seems that after two years, The Ministry of Health has launched the draft of the Royal Decree on the Evaluation of Health Technologies (ETS)which will now define the approval and financing process for medicines and health technologies. This Royal Decree began as a public consultation with the aim of aligning with European regulations (EU Regulation 2021/2282), but it goes further because the project aims to promote the evaluation processes of health technologies to improve efficiency and ensure that everything the world has access to medicines and health products.
In Europe, each country makes its own decisions and establishes its criteria for access to treatments and “this fragmented the European market,” commented to this newspaper the partner responsible for Health & Life Sciences at EY, Borja Sangrador, and the partner of public law of EY Abogados, Laura de Pedro. In Spain, the evaluation of health technologies to date has been managed by the Spanish Agency for Medicines and Health Products (AEMPS) and the Spanish Network of Agencies for the Evaluation of Health Technologies and Benefits of the National Health System (RedETS), each with its own methodology.
Now, although the regulation is framed within a common framework and the standard has arisen “to guarantee equitable and efficient access to health innovations throughout the EU”, pointed out the two EY partners, it does not mean that all EU countries European Union implement the same measures. “Each State has the flexibility to adapt these principles to its own national context, adjusting procedures and priorities according to its health needs and structures.“, pointed out the two EY partners.
The Spanish regulations are full of new features for the health system. For example, It is expected that the use of resources will be optimized, Experts and patients are included in decision-making to prepare analyzes of new medications or technologies. In this way, the bodies in charge of carrying out studies of new medicines “will ensure that patients, clinical experts and other relevant experts are involved individually or collectively in the evaluation process, giving them the opportunity to make contributions to the draft reports”, indicates the standard.
From 650 days to 210 days
Likewise, the Royal Decree encourages the creation of health innovations to improve access to new medicines and for this, in addition, approval deadlines are established for a new drug, in such a way thatThe time will be drastically reduced from the current average of 650 days to 210. Likewise, the most striking thing is that Mónica García’s department is committed to a tight schedule. “For the completion of the report on the clinical part of the medications, the deadline will be 90 calendar days after the communication of the decision by the competent body for its authorization,” the text begins. The same three-month period will be added for the economic report. Furthermore, “these deadlines will be extended by an additional 30 calendar days if, at any time, during the preparation of the draft reports, it is considered necessary to obtain other specifications or clarifications.”
The importance of autonomy
Furthermore, and as until now, the autonomous communities will have a main role in the final decision-making, with six regions having a direct vote in the last part of the approval process. This was an old demand from both healthcare professionals and people suffering from a disease related to the new drug. Until now this issue had been reluctant, but the new text allows the possibility. In general, The Ministry of Health sees this Royal Decree as an opportunity to grow the industrial capacity of the Spanish pharmaceutical and technological sector.
“Although it would be possible to have a certain industrial implementation and for these health technologies to not be used in the country, reality indicates that it is difficult for a health technology produced in one country to have a commercial run in others if it is not equally marketed in the country of origin. […] It is worth drawing attention to a double impact: on the one hand, the direct positive impact on industrialization, employment and trade balance; on the other hand, the positive impact it also has on strategic autonomy,” the document says.
Benefits for companies and patients
The defenders of this Royal Decree argue that there are many benefits it will have, not only for companies in the sector, but also for society as a whole, since these technological advances will mean an improvement in the quality of life of people and, therefore , an increase in life expectancy. Besides, The efficiency of the entire healthcare system will be improved, which will reduce waiting times. However, patients will have access to more efficient treatments and medications that will adapt to their needs.
In the case of the healthcare system as a whole, and as the two EY partners point out, “the advantages focus on efficiency and sustainability. Healthcare technological evolution encourages research and development of new solutions.” On the other hand, the regulations focus on small and medium-sized companies, which will also obtain benefits from this Royal Decree. “SMEs will benefit from administrative simplification and reduced fees, which will foster both their competitiveness and innovation in the health sector in general,” Sangrador and de Pedro stated. And they added that “this support for SMEs will undoubtedly contribute to energizing the market and facilitating the entry of new technologies into the health system.”
The regulations have not yet been approved and are still a project on the table.. Therefore, when can we start to see the first green shoots? In the short term, transparency in the processes and management of these will reinforce trust in the health sector, which will promote the active participation of all those involved – patients, professionals and organizations -, in addition to reducing bureaucratic obstacles and their costs. . All of this will make “faster access to innovative treatments and technologies, benefiting patients, particularly those with chronic diseases or those who are in rural areas,” commented Sangrador and de Pedro.
In the medium term, a better use of resources will begin to be seen, allowing us to be more efficient and focus on the development of new tools and methodologies, achieving a more accessible and equitable health system. However, to be able to appreciate more long-term changes, we will have to wait. The EY partners highlighted that “over time, the Spanish healthcare system is expected to improvemore competitive at an international level, and that cost-effectiveness evaluations allow for a better distribution of resources“, and added that “industrial development and research will also be strengthened.”
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