Association Nationale des Etudiants en Pharmacie de France
ANEPF
L'Association Nationale des Etudiants en Pharmacie de France, est une association fondée le 14 mars 1968 à Paris et régie par la loi 1901, faisant d'elle une association à but non lucratif.
ID: 539785135277-22
Lobbying Activity
Response to Evaluation and revision of the general pharmaceutical legislation
26 Apr 2021
Access to medicines and shortages have today more than ever raised questions. Regulatory approaches as well as the regulation of supply and demand condition a fluctuating market, ranging from the promotion of generics and the multiplication of patents to high-cost technological innovations
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Transparency of the industry R&D costs, conflicts of interest and information on health products could be improved by strengthening collaboration between European and national regulatory authorities and industries. The EMA support to national agencies in marketing and recommendations on the minimum reimbursement rate would allow better availability of these products, as well as their accessibility within the member states. Homogeneous availability must be accompanied by price harmonization, made possible by the creation of sub-working groups between countries such as the BeNeLuxA.
Finally, the beneficial effect of generics and biosimilars in regulating the health products market should not be overlooked.
With regard to shortages, we need to move towards European production, diversification of supply, and transparency of manufacturers on their production capacity and internal audits facilitated by the European agencies.It also seems essential to carry out centralized statistical studies on the demand. Finally, the pharmacist could become the central actor in the management of shortages at the European level.
Antimicrobial resistance is the consequence of 33,000 deaths per year, and 1.5 billion euros. The decrease in private investment and the lack of innovation are limiting factors. The commitment of SMEs to research is sometimes undermined by a market that is not sufficiently profitable and by recommendations limiting the use of antimicrobials. Thus, funding for biotechnology R&D, patent extensions, or market exclusivity for these promising antimicrobials would stimulate innovation. The participation of European public authorities in initiatives such as the AMR Action Fund or the relaunch of the DRIVE-AB would both support the financial development and test new business models that would benefit these innovations. Concerning good prescribing practices and the use of existing antibiotics, due to the limitations of the EU competences in health, an update of the Official Journal guidelines on the prudent use of antimicrobials in human and animal health, as well as a promotion of the role of the pharmacist as a central actor in the regulation between the prescription and the use of antibiotics, represents an important first step. Also, transnational clinical studies, reflecting this cross-border phenomenon, would allow the dissemination of the different good practices and the adoption of unit dispensing. Finally, emerging tools such as AI to take into account the patient profile in prescribing through digital health spaces, as well as new agencies such as HERA, soon to be competent in data coordination and centralization, should be implemented today. Finally, the integration of One Health in all considerations through the study of the ecological impact of our productions, the development of labels to encourage industrialists and human and veterinary prescribers as well as the use of the PBT index via a European harmonization would allow a complete approach and a mobilization of all health actors concerned.
The development of a European research program to facilitate multinational clinical studies for rare diseases, or the reinforcement of the EURAXESS platform to improve the mobility of researchers, would allow those issues to be extended to a larger area of dialogue. This training should also be anticipated by requesting bi-annual reports on the skills required from professionals directly, allowing for example the integration of digital technology, AMR and environmental health into the priority training base. Finally, the inclusion of students in stakeholder groups such as the training ambassadors or the pact for skills would adapt skills.
Read full responseMeeting with Anne Bucher (Director-General Health and Food Safety)
8 Jul 2019 · Les politiques de prévention; La e-santé; Les maladies rares; ’anonymisation des données de santé; l’indépendance de l’Europe dans la production de ces thérapies innovantes; L’antibiorésistance; politiques vaccinales.