Salud por Derecho, together with eight other national and international organizations, has sent a letter today to members of the ENVI Committee, urging them to ensure that the review process of the European pharmaceutical strategy is an opportunity “to improve” the hospital exemption, rather than a chance to “dilute and regress” what has proven to be highly effective in saving lives.
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Dear Member of the European Parliament,
The current review of the pharmaceutical package proposed by the European Commission presents an opportunity to address the bottlenecks and difficulties within the existing legislative framework concerning equity, access, and affordability of health technologies. The dossier related to the proposed Directive on medicinal products for human use, now in ENVI, already has a draft report addressing the hospital exemption (HE).
Since its regulation in 2007, HE has proven to be a successful initiative for the development of advanced therapies. Widely perceived by the scientific community as a positive instrument, HE allows hospitals to innovate and respond to the needs of numerous patients, with Spain offering many positive experiences in this regard. The current review process should aim to enhance HE, not serve as an opportunity to dilute and roll back what has proven to be very useful in saving lives. However, the amendments that some parliamentary groups are proposing jeopardize this instrument and the Spanish model of manufacturing advanced therapies in National Health System hospitals. We would therefore like to highlight the following:
- HE should be safeguarded as it guarantees patient access to newly developed products that respond to a health need and provides opportunities for alternative research and development (R&D) within hospitals. In addition, products approved under HE, meeting the criteria of quality, safety, and efficacy, should continue to be available to patients regardless of the marketing authorization approvals of other products for the same indication. Restricting their use over time, as proposed in the current draft report, would compromise their effective implementation.
- HE should entail data entry requirements equivalent to those of centralized authorization in terms of preclinical and clinical data and manufacturing in compliance with safety, vigilance and quality standards. An EU-wide registry should be created to track all HE products at the European level so that collaboration and transparency between hospitals and non-profit organizations can be strengthened.
- HE needs strong support leading to authorization by the EMA to ensure EU-wide access. In addition, the competent authorities should provide scientific advice to academic and non-profit institutions by allocating the necessary resources for this and by reinforcing the PRIME scheme. These institutions with a non-commercial profile will need support, not only for the different phases during clinical trials, but also with regulatory and industry procedures. Funding should therefore be available at both national and European level for this purpose.
- Transparency around public funding of HE and the reimbursement price are very important aspects. Therefore, the final prices of all health technologies, especially those with public support for their development, should be made public. In pricing and reimbursement processes, priority should be given to academic and publicly funded advanced therapies, and transparent, non-exclusive licensing agreements that allow knowledge transfer should be favored.
We believe that these elements should be incorporated into the current Directive under review. We hope you will consider supporting amendments that move in this direction. By doing so, and under the highest standards of safety, quality and efficacy, we will ensure more innovation, more access, greater affordability, to the benefit of all patients.
The undersigned organizations remain at your disposal for any further exchange or clarification that may be necessary in this regard.
Yours sincerely,
The undersigned organizations
This initiative has been promoted by Salud por Derecho and endorsed by the Spanish Society for Immunology – SEI, Catalan Society for Immunology – SCI, Médicines du Munde International Network, Médicos del Mundo España, Médicines du Munde France, Asociación por el Acceso Justo al Medicamento, No Gracias, and Health Action International (HAI)
