for non-prescription medicines
On 17 April 2013, the Steering Committee of the Process on Corporate responsibility in the pharmaceutical sector adopted the report of the stakeholder working group co-chaired by the European Commission and the United Kingdom on "Promoting good governance for non-prescription medicines".
All EU member States Members and EFTA (European Free Trade Association) countries participated in the Steering Committee that adopted the report, together with European stakeholder organisations representing patients and consumers, health professionals and providers, payers and industry. Key points from the report are presented below.
The role of self-care and self-medication in healthcare
“As part of self-care, self-medication enables people to treat or prevent short term or chronic illnesses when they consider they do not need to consult a doctor, or which they may treat after an initial medical diagnosis. Research reveals the positive effects of patient empowerment and self-management, and as healthcare moves closer to the patient, self-care has the potential to play an increasingly greater role in public health.
Over the years the practice of treating ailments with non-prescription medicines has developed as the importance of its place within healthcare systems became recognised, and the process of reclassifying medicines from prescription only to non-prescription has progressed to allow more effective treatments to be made available for self-medication.”
Reclassifications & innovation
Consensus is reached with the report that: “while the safety of non-prescription medicines must remain a key priority when reclassifying a medicine from prescription only to non-prescription, it is also important that the benefits, as well as the risks of non-prescription medicines are considered" and that: "the added value of the use of a medicine without prescription, both for individuals and for public health, should support a decision for the reclassification of a product from prescription only to non-prescription status.”
The critical role industry plays in innovation is highlighted in the report, which notes that: “It is important to recognise the costs to industry and considerable efforts invested in reclassification and in supporting the introduction into the market of a new reclassification in relation to the limit of a 12 month data exclusivity period in the EU."
Examining experiences with limited uptake of certain reclassified products, the group considered that: "The low uptake of reclassified products suggests a limited exploitation of the public health benefits of reclassification except for those cases of non-prescription availability of generic versions" and warned that "If reclassification becomes an unacceptable commercial risk this could inhibit access to non-prescription medicines in the future.”
Addressing how to overcome challenges in the future, the group concluded that: "As reclassifications are increasingly complex with the need for extensive educational and risk management programmes it may be necessary to consider whether further incentives are needed to encourage manufacturers to undertake expensive switch programmes." The report notes that "In the United States and Japan a period of data exclusivity of three years for a reclassification is provided to incentivise research on self-care”, as opposed to the limited one-year exclusivity period in Europe.
Communication & self-regulation
It is also acknowledged in the report that “People want to have a more active role in their own healthcare, including in the decisions about what medicines to take. When it comes to access to self-medication, information and support translate into empowered patients who can benefit fully from the opportunities of self-care and who can practise it safely and effectively with informed choice. As people take on greater responsibility for their healthcare, the need grows to become better informed. It is important for people to have access to high quality information from multiple sources and that they are provided with information in a variety of formats to meet the needs of different patient groups."
Identifying the characteristics of the audience of various communication activities on non-prescription medicines, the group observed that: “When considering wider access to non-prescription medicines it is important to take into account the needs of people of varying health education and literacy, to ensure that they can read and understand the label and leaflet, and use the medication correctly. At the same time, decisions on wider access should take into account the habits and needs of patients who will take a medicine in accordance with the instructions and seek advice where necessary from a health professional.”
The group also discussed the outcomes of a meeting of European advertising regulators, who “recognised that advertising has a role in improving access to non-prescription medicines by raising awareness of the availability of a product without prescription and what it can be used for." Regulators took note at this meetingof the fact that: “Self-regulation of advertising of non-prescription medicines is common". They "... considered that self regulation is particularly effective where there is prior vetting of advertising material and/or competitor review of advertising, with companies in competition monitoring each other.”
Pricing, reimbursement, incentives to self-care
The group briefly addressed how to best take advantage of the economic and public health benefits of self-care for the society. In particular, it is noted in the report that: “Acknowledging the economic and public health benefits of self-medication, (other) countries implemented measures that incentivise citizens to practise responsible self-care. These may include tax deductions for out-of-pocket purchases of non-prescription medicines or a self-medication budget (i.e. an amount of money to be spent on non-prescription medicines) as part of the health insurance coverage.”
With regard to pricing, the report notes that: "The absence of pricing controls for non-prescription medicines in Member States may play a role in reducing (…) inequalities (regarding the right to practise self-care)", and reiterates the outcomes of the EU Pharmaceutical Forum, where: "In examining the pricing of non-reimbursed, non-prescription medicines in 2007, the EU Commission and the EU Pharmaceutical Forum have already advised that Member States should abstain from price control for these products.”
The working group agreed a set of recommendations on how to achieve good governance for non-prescription medicines. These recommendations are presented in the image below and detailed in page 38 of the final report (also displayed below).
The European Commission, member states and European stakeholder organisations participating in this initiative committed to follow up on these recommendations to promote and expand the uptake of non-prescription medicines and the practice of responsible self-care in Europe.
Good governance for non-prescription medicines
The European Commission launched in September 2010 the Process on Corporate Responsibility in the field of pharmaceuticals. The process comprised three platfroms on Ethics and Transparency, Access to Medicines in Europe and Access to Medicines in Africa.
The Platform on Access to Medicines in Europe included a project group on "Promoting good governance for non-prescription medicines". The project group examined governance beyond the regulatory process and the work of the participating stakeholders focused on the role of industry, governments, regulators, health professionals, patients and consumers to identify and ensure that the correct measures are in place to facilitate the availability and uptake of non-prescription medicines, as well as their safe and responsible choice and use.