I. A philosophy of individual participation and empowerment is vital in responsible self-medication |
People are demanding greater independence and responsibility in their healthcare. They are more assertive, more questioning and more concerned about their options. They want to exercise greater judgement in informed and responsible self-medication. It is AESGP's aim to remove any obstacles preventing individuals from realising their full potential in terms of self-care and self-medication. |
II. The social and economic value of self-medication is widely recognised |
| The social and economic value of self-medication is widely recognised. The economic value of self-medication has been measured in the AESGP study on the Economic and Public Health Value of Self-Medication, which demonstrated that shifting only a small part of medication currently prescribed to treat minor ailments to self-care can lead to huge savings for the social security institutions as well as the economy as a whole without jeopardising equity in healthcare. The social value of self-medication is realised by managing common health problems from home without necessarily involving the healthcare system. In this way public resources used for treating minor ailments are re-directed towards more serious illnesses that have a large impact on individuals and public health. In light of this, there is growing support for self-medication from many official institutions, both inside and outside the European Union (e.g. the European Parliament, the European Commission, the EU's Council of Ministers, the World Health Organization, etc.). |
III. A clear distinction between prescription and non-prescription medicines is needed
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A clear distinction between prescription and non-prescription medicines will promote self-care. The approach used in the European Union is that all medicinal products are available without a prescription from a medical doctor unless they meet certain criteria laid down by law (Title VI of Directive 2001/83/EC as amended). The decision on whether a product is classified as a prescription-only or a non-prescription medicine is part of the marketing authorisation process for medicinal products in the European Union. This approach nevertheless requires an adequate enforcement mechanism to be effective.
The authorisation process in many countries is sometimes very lengthy, even for products with well-established ingredients. AESGP is striving towards faster access to market for self-care products. Some of AESGP's efforts to harmonise the regulatory environment for all self-care medicines and proposals for change are laid down in its 2008 publication Smart Regulation 2015. |
IV. Reclassification of ingredients and indications from prescription to non-prescription status
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| With a distinction between prescription and non-prescription medicines in place and experience with newer medicines constantly evolving, the reclassification of ingredients and indications from prescription to non-prescription status (also called "switch") needs to be facilitated. AESGP supports regular updating of the classification status of medicines and indications in the light of new information and experience. Within the EU, the reclassification policy in some countries is more advanced than in others. The less advanced countries could learn from the switch experiences in other markets. AESGP carries out regular surveys of the classification status of more than 200 ingredients widely used in self-medication. The results are available in the form of three tables from the AESGP website. |
V. Consumer information / Different forms of communication fulfil distinct roles
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One of the most effective ways for governments to encourage consumers to achieve greater independence in healthcare is to allow the self-care industry to provide appropriate and effective consumer information whereby product information is communicated in an appropriate manner. Effective communication with the end user (the consumer) is fundamental to achieving responsible self-medication. There is wide recognition that different forms of communication have distinct roles.
Awareness raising
The most effective means to satisfy individuals’ wish to be adequately informed about the existence of indications suitable for and the products available to practise responsible self-medication is through mass-media advertising. To be effective, media advertising must be simple. To be efficient, it must be remembered.
Detailed information and instructions for use
Once consumers have been made aware of the existence of suitable products to treat their ailment through the mass media, they should receive detailed production information. The right place for this is the product itself. The information can be included either on the outer packaging (where the information is important prior to purchase) or on the package insert or patient information leaflet. It is important that this information, which includes warnings, contra-indications and side effects as well as appropriate dosage instructions, is in line with people's expectations and is written in a language that is easily understood by the consumer.
It is thus entirely inappropriate to include the detailed product information the consumer needs in media advertising. To do so would render the advertising ineffective, especially when considered in the context of competing messages from manufacturers in other product categories. Instead, AESGP advocates including the instruction to read the label and, where appropriate, to seek the advice of a health professional in all media advertising.
Advertising control
More and more countries move from a primarily government-led system to control the advertising of non-prescription medicines to a self-regulatory control system (either before or after the advertising appears) supervised by government institutions. AESGP advocates the adoption of such a self-regulatory approach: it improves the quality of the control while at the same time reducing a costly administrative burden for government.
The use of trade names
Trade names are an important aspect of consumer communication, and a principal asset for the self-care industry. They provide consumers with important reassurance concerning quality and reliability of the product they intend to purchase. By extending an established trade name to similar self-care products, consumers are made aware of the origin of these products within the established range. Prefixes and suffixes can be used to clearly indicate the target group or target indication for which the product is meant without confusing the consumer.
European guidance on the use of trade names in the centralised procedure states that a positive connotation in the name of a non-prescription medicine is acceptable (Article 2.4.4: “In order to help self-selection and compliance by patient / consumers, it is acceptable that (invented) names have a positive connotation and / or be informative.”).
It is also important when switching the classification of a medicinal product from prescription to non-prescription that the same trade name can be maintained. The rationale is explained in the AESGP publication "The Value of the same Trademark for medicines with a different Legal Status”. Forcing companies to invent a new trade name for the non-prescription version of the same medicine confuses health professionals and consumers alike. Nevertheless, restrictions remain in place in certain countries in Europe. AESGP is committed to removing these restrictions in the most consumer-friendly manner. |
VI. No government intervention desired in pricing of non-prescription medicines
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| Given the highly competitive market environment in which non-prescription medicines find themselves, AESGP finds that that consumers' best interests are served by a free market in which manufacturers of self-medication products determine their own prices without government intervention. This is supported by the fact that, where such price freedom exists, price increases of these products have mostly been in line with, or lower than, the inflation rate. |
VII. Increased visibility of OTC medicines helps the consumer
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| AESGP advocates better visibility for non-prescription medicines in approved outlets on the basis that this provides consumers with more information on the range of products available and allows them to read the outer packaging before purchase. It should be noted that self-selection in pharmacies in Sweden and Finland is demonstrably stimulating the dialogue between consumers and pharmacists, resulting in better knowledge of self-medication products and their appropriate use (publications: "The Visibility of Self-Medication Products in the Changing Pharmacy Environment, June 1997"; "Improving Visibility of Self-Medication in Pharmacies, May 1998"). This is supported in a Common PGEU-AESGP statement on the presentation of non-prescription medicines to enhance the role of the pharmacist and a Report of the PGEU-AESGP Workshop "How appropriate presentation of non-prescription medicines enhances the role of the pharmacist", March 2002. |
