AESGP Self-care Agenda 2020
The AESGP 2020 agenda summarizes the proposals of the consumer health industry how to improve availability of high quality self-care products in Europe. Suggestions are divided into the three legal categories the industry is involved: non-prescription medicines, food supplements and substance-based medical devices. By implementing the suggestions the service to European citizens could be considerably improved.
download document AESGP Self-Care Agenda 2020
EXECUTIVE SUMMARY
Non-prescription medicines, self-care medical devices and food supplements make an important contribution to the health and well-being of European citizens. People want to take responsibility for their own health and this, combined with demographic changes and the increasing cost of professional healthcare, means that more must be done to develop and support self-care. This document outlines how European citizens ability to self-care safely and effectively can be enhanced by improving the regulatory system for selfcare products.
GENERAL PRINCIPLES
– The public health, economic and social benefits of self-care products should be recognised by all partners – The implementation of legislation affecting the self-care sector needs to be appropriate and proportionate. Mechanisms need to be put in place to check whether legislation is still fit for purpose and lessons learnt should be used to improve the implementation. – Policy-making should be evidencebased with meaningful cooperation/ dialogue between authorities, stakeholder representatives and industry partners.
NON-PRESCRIPTION MEDICINES
– The routes to market (centralised, mutual recognition, decentralised and national procedures) need to guarantee timely market access for non-prescription medicines including reclassification from prescription to non-prescription status (“switch”). The benefits of non-prescription medicines need to be taken into account in the evaluation process e.g. through the use of recognised risk-benefit decision making models. – The implementation of the EU pharmacovigilance legislation should reduce unnecessary administrative burdens and avoid unjustified restrictions for non-prescription medicines. – Advertising of non-prescription medicines to the general public in all media should be permitted in accordance with the EU legislation. – Free pricing for manufacturers of nonprescription non-reimbursed medicines should be established everywhere. – The value of brands including umbrella brand should be widely recognised.
MEDICAL DEVICES
– Medical devices composed of substances or combinations of substances should be classified according to their risk profile. The definition of a pharmacological, immunological and metabolic mode of action should be rational and proportionate.
FOOD SUPPLEMENTS
– Interactions between EFSA (the European Food Safety Authority) and applicants should be improved by permitting guidance and scientific advice e.g. with regard to health claims. – The ongoing re-evaluation programme and reorganisation of the food supplements categories should lead to workable and sustainable conditions of use for food additives that reflect balanced judgement and robust science.
AESGP
AESGP Self-Care Agenda 2020
