AELMHU's contributions to the new public consultation of the Ministry of Health.

AELMHU's contributions to the new public consultation of the Ministry of Health.

The Spanish Association of Orphan and Ultra Orphan Drugs (AELMHU) has participated in the process of contributions to the Preliminary Public Consultation on the Draft Bill amending the Consolidated Text of the Law on Guarantees and Rational Use of Medicines and Health Products.

From our Association, we welcome the fact that the current Executive considers Rare Diseases a priority, stating in its government agreement its commitment to "integrate the needs of rare diseases in the overall planning of universal coverage, ensuring access to diagnosis and treatment for all people, regardless of where they live and the pathology with which they live". (section 2.2.11.).

In order to contribute to materialize the impulse that this commitment implies, AELMHU considers it very opportune to update the current law on guarantees and rational use of medicines and health products with the aim of continuing to deepen in numerous aspects such as the recognition of the economic and social value that pharmaceutical research on new products and indications contributes, equity in access to these treatments, the streamlining of bureaucratic processes, the improvement of the evaluation process, etc., and to provide greater certainty, transparency and participation in the entire approval process, among other issues.

For this reason, and from the conviction that this is an issue that concerns us all -patients, professionals, industry and public decision-makers-, we have participated in the Public Consultation process, making a series of recommendations in different areas:

  1. Financing and pricing of the HMH and their inclusion in the pharmaceutical provision of the National Health System, in order to provide certainty, agility and greater transparency in the processes.
  1. Product evaluation process, proposing a consensual solution that allows information to be shared in an agile manner (preferably in digital format), establishing a predictable procedure for the presentation, resolution and reporting of claims, and increasing patient participation in this phase of the process, with a "voice and vote" in decision-making, among others.
  1. Financing linked to clinical and financial results, with actions aimed at greater transparency and governance, to homogenize the existing territorial disparity and facilitate data collection, among many others.
  1. Exclusion from the Reference Price System.
  1. Exclusion of Orphan Drugs from the extension of the four-monthly contribution for dispensation in healthcare centers.
  1. New mechanisms to speed up access for patients with Rare Diseases, reflecting the specificities of Orphan Drugs and the need to encourage them, in line with the provisions of the European Regulation on Orphan Drugs, and contribute to improving access conditions.
  1. Incorporation of the patient and clinician perspective in the support groups of the Advisory Committee for the Financing of the NHS Pharmaceutical Benefit (CAPF).
  2. Exemption of the users' contribution in the outpatient pharmaceutical service for Orphan Drugs.
  1. Incorporation of the lessons learned from the pandemic in terms of streamlining authorization and commercialization processes, use of digital solutions for clinical trials, regulatory submissions and home-based care, and public-private collaboration.
  1. Sufficient funding for the Spanish Agency of Medicines and Health Products (AEMPS) to enable it to carry out its work with agility and guarantees.
  1. Ensure equity in access between different Autonomous Communities.
  1. Incentives for pharmaceutical innovation.
  1. And support for the digital transformation of the sector.

If you would like to know the details of all these proposals, please consult the complete Recommendations document.

AELMHU Recommendations