Promoting good governance for non-prescription medicines

7/30/2019 Promoting good governance for non-prescription medicines

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Final - adopted by Steering Group 17/4/2013

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REPORT OF THE WORKING GROUP ONPROMOTING GOOD GOVERNANCE OF NON-PRESCRIPTION

DRUGS IN EUROPE 1

June 2013

1 The present document is without prejudice to any existing or future EU/ national and international legislation.


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Table of contents

1. Overview and Context..........................................................................................................3

2. Background ..........................................................................................................................4

3. The Landscape......................................................................................................................6

4. Methods and approaches of the Project Group ..................................................................13

5. Findings from review of evidence......................................................................................16

6. Success factors, barriers and enablers to access to non-prescription medicines................25

7. Conclusions ........................................................................................................................32

8. Recommendations ..............................................................................................................38

9. Looking ahead ....................................................................................................................41

References .................................................................................................................................42

Glossary .....................................................................................................................................45

Annex 1......................................................................................................................................48

Annex 2......................................................................................................................................54

Annex 3 Group Members .......................................................................................................59

Annex 4......................................................................................................................................60

Annex 5 - National initiatives to widen access to non-prescription medicines.........................73

Annex 6 - National Best Practice examples...........................................................................83


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1. Overview and Context

1.1 The healthcare environment is changing across the EU. With an ageingpopulation and economic constraints on healthcare systems there is an increasedfocus on how to make best use of healthcare resources. Self-care has a role to play -in encouraging people to take more responsibility for their own health and wellbeing;making healthy life choices; consulting their doctor and or pharmacists whereappropriate; and knowing if and when medical treatment should be sought.

1.2 Patient behaviour is also changing across Member States, particularly with regardto growing empowerment in self-care, new routes of access to medicines, and cross-border patient movement. As part of self-care, self-medication enables people to

treat or prevent short term or chronic illnesses when they consider they do not needto consult a doctor, or which they may treat after an initial medical diagnosis.Research [Ref 1] reveals the positive effects of patient empowerment and self-management, and as healthcare moves closer to the patient, self-care has thepotential to play an increasingly greater role in public health.

1.3 Over the years the practice of treating ailments with non-prescription medicineshas developed as the importance of self-care within healthcare systems has becomerecognised, and the process of reclassifying medicines from prescription only to non-

prescription has progressed in some Member States to allow a wider range oftreatments to be made available for self-medication[Ref 2].

1.4 Patient safety is a prime consideration in all aspects of self-care, including in theregulation of non-prescription medicines within the EU. Robust evidence is required todemonstrate that a medicine can be used safely and appropriately without medicalsupervision before it can be classified as non-prescription, and ongoing monitoring ofsafety in use is required.

1.5 The range of non-prescription medicines is evolving as more treatments are

becoming available for conditions that have traditionally been self-managed and asmedicines are reclassified to non-prescription with new self-medication indications.

1.6 Recognising that legal status remains primarily a national competency there isconsiderable variability in availability of non-prescription medicines within the EU.Good governance of non-prescription medicines goes beyond the regulatory processand is part of corporate social responsibility in a wider sense. People should be ableto look after themselves, and need the tools and support to do this. Governments,


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regulators, health professionals, patient and consumer representatives, and non-prescription medicines manufacturers all have a responsibility to ensure the correctmeasures are in place to facilitate the availability and uptake of non-prescriptionmedicines, and their safe and responsible choice and use.

1.7 The Project Group on Promoting Good Governance of Non-prescriptionMedicines in the EU was one of the initiatives of the Platform on Access to Medicinesin Europe - a work area of the Process on Corporate Responsibility in the Field ofPharmaceuticals. The Process was dedicated to enhancing collaboration amongMember States and all interested relevant stakeholders in order to find common, non-regulatory approaches to timely and equitable access to medicines.The objective ofthe Project was to identify the necessary elements to ensure availability, uptake, andinformed use and choice of non-prescription medicines.

1.8 The Project was undertaken within a changing European legal environment inlight of the implementation of the revised Pharmacovigilance legislation,implementation of the Falsified Medicines Directive and plans for new legislation inrelation to patient information. Furthermore, it was recognised that the regulatoryenvironment for authorisation of medicinal products is changing in relation to use ofthe centralised, mutual recognition and decentralised procedures.

1.9 The Project investigated in particular the role of competent authorities,pharmaceutical companies, consumers and patients, and health professionals infacilitating uptake and proper use of non-prescription medicines. All these

stakeholders were represented on the Project Group.

1.10 This Project Group offered a chance for all stakeholders to come together andidentify measures needed to ensure that EU citizens have access to non-prescriptionmedicines and are fully supported to practise safe, effective and appropriate self-care.

2. Background

2.1 The European pharmaceutical sector is confronted today with many challenges.

Due to the importance of medicinal products for the protection of public health, it isnecessary to ensure that all partners exercise their responsibilities in accordance withpublic health and societal needs. The Terms of Reference and the composition of theProcess on Corporate Responsibility in the Field of Pharmaceuticals are provided inAnnex 1 to this report.


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2.2 The rationale for the Process on Corporate Responsibility in the Field ofPharmaceuticals was not to be confined to one objective. There was an effort topursue multifold objectives i.e. to:

I. improve access to medicines across the EU;

II. discuss issues relating to the long term viability of the EU basedpharmaceutical industry, and

III. enhance the role that patients can play in determining and addressing theirmedical needs.

2.3 Due to the wide scope of the topics the following three independent platformswere launched under the Process:

Platform on Access to Medicines in Europe

Platform on Ethics and Transparency

Platform on Access to Medicines in the developing countries with a focus onAfrica.

2.4 Under the Platform on Access to Medicines in Europe the following project groupswere put in place in order to give the participating stakeholders the opportunity toexchange ideas and knowledge, as well as to explore non-regulatory conditions that

may impact on access to medicines after their marketing authorisation:

Mechanisms of coordinated access to orphan medicinal products

Capacity building on managed entry agreements for innovative medicines

Facilitating supply in small markets

Market access for biosimilars

Prioritisation of medicines

And

Promoting good governance for non-prescription medicines

2.5 Since the organisation and delivery of healthcare and the classification ofmedicines are both primarily national competencies, the extent to which self-care is


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practised and encouraged, and the range of medicines available without prescription,as well as the circumstances under which they can be accessed, varies widely acrossthe EU. Some countries have well developed self-care systems and policies,enabling access to a wide range of non-prescription medicines for acute and chronicconditions and for ill health prevention, as well as models of care within nationalhealth systems to encourage and empower people to self-manage their conditionsunder the supervision of a health professional. Other countries have a morerestricted range of non-prescription medicines and self-care is limited to the treatmentof minor self-limiting conditions. However, the situation is dynamic and, increasingly,national governments are looking at how self-care and self-medication can bettercontribute to healthcare.

2.6 The Project Group on "Promoting good governance for non-prescriptionmedicines" sought to gain a better understanding of the different approaches and

attitudes to availability and use of non-prescription medicines across the EU. TheGroup sought to identify the key factors that contribute to good access to non-prescription medicines in order to explore common, non-regulatory approaches totimely access to non-prescription medicines irrespective of national decisions onclassification, and to provide a source of information for governments who wish totake national action to widen access to non-prescription medicines while maintainingsafeguards to public health. The Terms of Reference for the Project Group are set outin Annex 2.

3. The Landscape

The role of non-prescription medicines in self-care

3.1. Access to non-prescription medicines allows people to take a more active role inthe management of their own health and in the treatment of common illnesses. Thesemedicines give people the responsibility for caring for themselves until or unless ahealthcare providers expertise is necessary, and equips them with the power to makea decision about their healthcare and to choose medicines that meet their needs andconditions. When people can treat common ailments themselves, it saves them time

and effort and can avoid a visit to the physician. Where appropriate, non-prescriptionmedicines can also help individuals to self-treat embarrassing conditions that theyare not willing to discuss with their doctor (see also 3.3).

3.2 While acknowledging that no medicine is risk-free, people believe fundamentallythat non-prescription medicines are safe and that they do not usually have serious


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side effects: the relative safety is seen as being proportional to the ease of access.Responsibility for safety is seen to be jointly held by the pharmaceutical industry andgovernment. When individuals have a poor understanding of the nature of non-prescription medicines and how to use them, there are risks of incorrect use, misuseor over consumption.

Patient empowerment

3.3 People want to have a more active role in their own healthcare, including in thedecisions about what medicines to take. When it comes to access to self-medication,good information and support translate into empowered patients who can benefit fullyfrom the opportunities of self-care and who can practise it safely and effectively withinformed choice. As people take on greater responsibility for their healthcare, theneed grows to become better informed. It is important for people to have access to

high quality information from multiple sources and that information is provided in avariety of formats to meet the needs of different patient groups.

3.4 Information on non-prescription medicines comes from a wide range of sources,starting with a clear and understandable label and package leaflet, and includingproduct websites and advertisements. People are confronted with a growing volumeof information that is increasingly personalised and interactive, and need to be able tomake sense of this in relation to their particular need and condition. Additionally,advertising messages should be communicated in a way that makes it clear that themessage is an advertisement and the product concerned is identified as a medicine.

3.5 Health professionals are an important source of objective and balanced adviceabout medicines and their uses. Patients understanding of the need to seekprofessional advice when necessary before buying a non-prescription medicine is partof health literacy and patient empowerment.

3.6 When considering wider access to non-prescription medicines it is important totake into account the needs of people of varying health education and literacy, toensure that they can read and understand the label and leaflet, and use themedication 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 withthe instructions and seek advice where necessary from a health professional.

3.7 With regard to some non-prescription medicines, certain population groupsincluding teenagers and people with drug addiction are particularly vulnerable. Somemedicines, such as painkillers can be abused in intentional overdose while there is arisk of laxative abuse by people with eating disorders. There is a risk of addiction to


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medicines containing codeine if they are not taken correctly. These risks need to bemanaged when considering widening access to non-prescription medicines.

3.8 Misuse of non-prescription medicines can also pose risks to the health of elderlypeople who are the largest consumers of medicines and are often on multiple

medicines. They are more vulnerable to adverse effects and to the risks of multiple orinappropriate medications. They may start using different non-prescription medicinesat the same time as their prescribed medicines without informing their doctor; this cancause adverse reactions that can remain undetected. Elderly people should beencouraged to discuss with their pharmacist or doctor before using different non-prescription medicines at the same time as their prescribed medicines.

The important role played by health professionals

3.9 Within healthcare today there are increasing demands on doctors time with anageing population requiring care for an increasing number of chronic conditions andongoing economic restraints on healthcare resources. Although responsible self-carehelps to ensure that best possible use is made of a doctors time, it is essential thatpeople who choose to self-medicate are able to recognise when their condition maybe the sign of a more serious underlying disease, indicating that a diagnosis andmedical treatment are needed. Care should be taken to ensure that access to non-prescription medicines does not lead to inappropriate self-medication and that non-prescription medicines are used appropriately so that patients do not delay in seekingadvice from a doctor if they have a serious condition. Doctors play a key role in

supporting their patients in self-care and in ensuring informed use and proper choiceof non-prescription medicines by the patient. In particular, they can reassure patientsif they are worried about a minor condition on which they are seeking advice andeducate their patients by explaining in certain circumstances, why they could havepurchased a medicine in a pharmacy.

3.10 The role of the pharmacist has evolved in healthcare systems. Pharmacistsexpert knowledge of medicines is well recognised and a broad range of pharmacyservices and more complex interventions in relation to medicines use and publichealth are available from pharmacies across the EU.

3.11 Supporting self-care is recognised by pharmacists in all Member States as beinga core activity of the profession [Ref 3]. Widely distributed in Europe and easilyaccessible pharmacists are often the first and sometimes the only health professionalto assist a patient in their self-care journey, in:

advising on the management of symptoms;


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providing advice on maintaining good health and avoiding illness, and;

selecting the most appropriate medication.

3.12 Pharmacists also have an important role to play in encouraging people to read

the label and patient leaflet and in reinforcing the information to ensure safe andeffective use of non-prescription medicines, particularly when there is a risk ofincorrect use or abuse. This is especially important with newly reclassified medicines.

3.13 In addition, pharmacists play an important role in signposting patients byreferring them to the doctor or another appropriate health service when medicalexamination or prescription treatment is considered necessary.

Variability of access

3.14 Non-prescription status is the natural classification for a medicine according toEU legislation. The range of non-prescription medicines available can include not onlymedicines to treat acute short term self-limiting conditions, but also medicines forchronic disease management and disease prevention.

3.15 However, there is great diversity in the number and type of medicines that areavailable without prescription across the EU. Specifically, according to a surveybased on primary data collected by the Association of the European Self-MedicationIndustry (AESGP), as of January 2011 there were only 5 molecules (see section 7)that are available in some form without prescription in 24 European countries, and 10molecules that are available without prescription in 22 European countries (mainly EUMember States) [Ref 4].Variability between Member States is related not only to thenumber of non-prescription medicines available, but also to the range of ailments forwhich non-prescription medicines can be accessed.

Diversity of approaches

3.16 While there is a common medicines regulatory framework in the EU, there is adiversity of approaches between Member States to controlling access to non-

prescription medicines, including different national decisions on the classification ofmedicines. In some countries, non-prescription status is determined on a product byproduct basis, in others it is substance based. There are also different approaches tothe limits for conditions of use for a non-prescription medicine so even if a substanceis available without prescription in a number of Member States, there may bedifferences in relation to, for example, the indications, treatment population, dose,strength, contraindications, and available pack sizes of medicines.


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3.17 Member States also have different national policies on distribution of non-prescription medicines, ranging from restricted availability from pharmacies only, towider access in supermarkets and other outlets, as well as via the internet with orwithout the supervision of a pharmacist [Ref 5].

3.18 There are also different approaches to reimbursement and pricing [Ref 6]. Insome Member States, reclassification to non-prescription will result in a product nolonger being reimbursed by national health insurance systems. Pricing policies alsodiffer between countries, with free pricing on non-prescription medicines being inplace in some countries, particularly if medicines are not reimbursed.

Industry and innovation

The non-prescription medicines market

3.19 Half of all medicines sold in the EU have a non-prescription status and over100,000 non-prescription medicines are estimated to be produced and marketed bymulti-national as well as many small and medium enterprises. The market in the EUin 2011 was estimated to be in the area of 27 billion Euro, or approximately 15% ofthe total pharmaceutical market [Ref 7]. The share of sales of non-prescriptionmedicines in various European countries differs considerably.

Innovation in the non-prescription medicines market

3.20 People have always used non-prescription medicines to deal with conditionssuch as headache, upset stomach, hay fever, cold sores, and diarrhoea. Innovationin the self-care market has resulted in people now being in a position to treat theseconditions with modern, clinically proven medicines. For example, whereas once theonly way to treat excess gastric acid was through use of an antacid, now people canuse alginate rafting agents to stop reflux or use H2-antagonists or proton pumpinhibitors (PPI) to reduce acid levels. New self-medication products are usuallydeveloped initially for supply on the basis of a prescription by a doctor and aresubsequently reclassified as non-prescription medicines based on their establishedsafety profile and potential for effective and safe use as such.

3.21. Innovation in self-care does not only concern new ingredients in non-prescription medicines, but also the indications that are considered suitable for self-management. Vaginal thrush, irritable bowel syndrome, high cholesterol, benignprostatic hyperplasia-related urinary symptoms, migraine, eczema and evenemergency contraception are now all accepted in certain European markets asconditions for self-management. In an EU-funded research project [Ref 8] the


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AESGP analysed the potential for innovation in the provision of care, examining howindividuals can take on a greater role in the management of their health with theintroduction of new indications for self-care. Possible self-care indications identifiedin this project ranged from the treatment of acute and chronic conditions that can beself-diagnosed, to those that would require a doctor consultation and/or healthprofessional advice before they could be self-managed.

The environment in which industry operates - How products reachthe market

National and European authorisation of non-prescription medicines

3.22 Every non-prescription medicine on the European market has been assessed forsafety and efficacy before it reaches the market and is continually monitored forsafety while it is marketed[Ref 9]. The same strict regulatory framework is used forboth prescription and non-prescription medicines and when prescription medicinesare being evaluated for suitability for non- prescription status. This ensures thatcitizens in Europe have access to safe and effective products of high quality. Thechange of legal status from prescription to non-prescription (switch) is addressed byArticle 74 of Directive 2001/83/EC and explained in the Commission guideline onchanging the classification for the supply of a medicinal product for human use(rev.January 2006).

3.23 Most non-prescription medicines have national marketing authorisations issued

by national competent health authorities which are valid only in the country in whichthey were issued. An increasing number of new prescription-only products areauthorised centrally by the European Commission to be marketed across the EU. Theuse of the centralised procedure for the authorisation of non-prescription medicines,however, has so far been limited, with 5 applications and 2 positive opinions to date(pantoprazole for short-term treatment of reflux symptoms in adults and orlistat forweight loss in adults with BMI of 28 or over). Moreover, if an application for a centrallyauthorised product to be classified as non-prescription through the centralisedprocedure has been unsuccessful, it is not possible subsequently to submit anapplication for a national marketing authorisation for an identical product even whenall national requirements for the marketing authorisation are met.

3.24 The centralised procedure ensures availability of non-prescription medicinesthroughout the EU. The Decentralised and Mutual Recognition procedures allownational products to be marketed across a number of European Member States. Theuse of these procedures for non-prescription medicines has been disproportionately
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low compared with the respective marketing authorization applications for prescriptiononly medicines.

3.25 As science, the practice of medicine and peoples ability to self-treat evolve andgrow, industry is interested in increasing European citizens access to self-care with

existing products, and by expanding the types of non-prescription therapies. The non-prescription industry aims at providing the same high quality and safe products to theentire EU market. However, different interpretations of the European legislation haveled to major differences in the range of non-prescription medicines available indifferent Member States. Companies operating in Europe through the Association ofthe European Self-Medication Industry (AESGP) have set out a programme forchange to address the barriers to an efficient regulatory environment [Ref 10].

3.26 Member States across the EU carrying out their own assessments of safety and

efficacy are aware of the need to address differences in the way regulations andguidelines are interpreted and applied throughout Europe. Platforms such as theEuropean Medicines Agencys (EMA) Co-ordination Group [Ref 11] and theCoordination Group for the Mutual Recognition and Decentralised procedures(CMDh) [Ref 12] provide forums for regulators to effectively address thesedifferences.

3.27 As the need for consistency and transparency in decision making for allmedicines at both EU and national levels has been universally accepted, the EMAhas launched a project on benefit-risk assessment to work in this direction [Ref 13].

At the same time, the non-prescription industry is also engaged with regulators andacademics in an open dialogue on how to ensure an appropriate benefit-riskassessment to fully take into account the specificities of non-prescription medicines.A proposal for a new benefit-risk model, specially adapted to non-prescriptionmedicines, has been published by independent researchers [Ref 14].

3.28 This benefit-risk assessment model for non-prescription medicines has at itsheart stakeholder engagement and communication. It aims to develop a commonapproach to the assessment of non-prescription medicines at different stages: whenthey are first put on the market, when they are evaluated for non-prescription statusand when their safety is monitored post-marketing.

3.29 Worldwide, few non-prescription medicines are protected by patents, butgovernments have recognised the need to provide other incentives to encourageinnovation. The EU pharmaceutical legislation (Directive 2001/83/EC) provides fordata exclusivity in the case of applications for new indications for well-establishedsubstances, when these result from significant pre-clinical or clinical studies having
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been carried out by the applicant [Ref 15]. Similarly, a one-year data exclusivityperiod can be given in the EU in the case of re-classification of a medicine fromprescription only to non-prescription status [Ref 16]if this results from significant pre-clinical tests or clinical trials carried out by the marketing authorisationholder/applicant.

Pricing

3.30 Whereas Member States usually control the prices of prescription onlymedicines supplied under national healthcare systems, no price control measuresapply for non-reimbursed non-prescription medicines in the majority of EU MemberStates. The pricing of non-reimbursed medicines was examined by the EuropeanCommission and the EU Pharmaceutical Forum in 2007, which concluded that pricecontrol is not necessary for non-reimbursed medicines. For these products, price

competition can steer the price evolution sufficiently well[Ref 17].

3.31 The consumer healthcare sector represents a competitive market, with strongcompetition not only between non-prescription medicines, but also from products ofother categories (e.g. medical devices, cosmetics, food supplements). Thereforepricing policy for non-prescription medicines is a determining factor for ensuring thefunctioning of a competitive market where manufacturers are incentivised to innovateand offer citizens the best value at an acceptable price.

4. Methods and approaches of the Project Group

4.1 The Project Group worked within agreed Terms of Reference, according to whicha detailed work plan was compiled.

Terms of Reference

Scope and Objectives:

1) To assess the situation on the ground in relation to access to non-prescription

medicines across Member States2) To identify examples of how access to non-prescription medicines can supportpatients to take shared responsibility for their own health care

3) To identify medicines where non-prescription access has the potential to have asignificant impact on public health and to consider what may be learnt fromexperience of successful and unsuccessful reclassifications


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4) To consider the barriers and enablers to the availability, uptake, informed use andchoice of non-prescription medicines, including:

how the current regulatory system operates in relation to non- prescriptionmedicines

statutory Product Information.

branding

the role of advertising and media communication about non- prescriptionmedicines, and information to support non-prescription medicines.

pricing and reimbursement issues

5) To explore health professional and patient attitudes and what may support aproactive and supportive approach to self-care.

Membership of the Group

4.2 The Project Group was co chaired by the UK Medicines and Healthcare productsRegulatory Agency (MHRA) and the European Commission. The membership of theProject Group comprised representatives from competent authorities, pharmaceuticalcompanies, consumers and patients, and health professionals. The Commissioninvited representatives from all Member States to join the Project Group and the

invitation was accepted by the Czech Republic, Denmark, Germany, Ireland, Italy,Lithuania, Portugal and the UK. A full list of those who participated in the ProjectGroup is at Annex 3.

Work plan

4.3 The Project Groups work was developed and coordinated through 12teleconferences and four face-to-face meetings two held in Brussels and one eachin Copenhagen and London. The Group agreed a work plan detailing various workstreams, and the methodology and actions required to deliver the work areas

covered. All members of the Group contributed significantly to the delivery of the workplan. Individual members took the lead on different items, with input and support fromthe rest of the Group. Considerable work was undertaken by group members inbetween contact times, collating information and exploring issues based on theirexperiences and expertise. Face to face meetings were used to share informationgathered, exchange views, and discuss and agree on the main recommendations.


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4.4 Work topics included:

An analysis of the factors that contribute to successful and unsuccessfulavailability, uptake and informed use of a medicine after it has beenreclassified

An historical overview of the development of the non-prescription medicinessector

An overview of studies examining the positive economic impact of self-care inEU Member States

Analysis of case histories of availability and uptake of non-prescriptionmedicines following reclassification, and of the impact of switches.

A review and study of the attitudes and experiences of patients and healthprofessionals to non-prescription medicines and self-care across the EU

An analysis of the education and training of health professionals to supportself-care and uptake of newly reclassified non-prescription medicines

An analysis of rules in Member States for advertising and provision of non-statutory information

A collation of national initiatives within Member States to improve access to

non-prescription medicines. Contributions were received from all MemberStates represented on the Group.

4.5 To support the work of the Group, the European Medicines Information Network(EMINeT) [Ref 18] was commissioned to map (Annex 4) the landscape of non-prescription medicines and reclassification across the EU Member States, focussingon four areas:

OTC market shares in the EU

Switches of active ingredients in the EU in the last decade

Distribution channels for OTC medicines in the EU

Pricing and reimbursement regulation for OTC medicines in the EU

4.6 EMINet was also commissioned to undertake a stakeholder survey in Europeancountries in order to identify the barriers and supporting factors for switches, and to


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explore the switch climate in those countries.

5. Findings from review of evidence

Map of the non-prescription medicines landscape in the EU

5.1 The mapping exercise undertaken by EMINeT [Ref 4,5,6,19]revealed a diversityof systems and approaches to the regulation, and access to market, of non-prescription medicines in Member States.

5.2 The analysis of switches of medicines or substances from prescription only tonon-prescription showed that a number of switches have been undertaken in severalcountries in the last decade, resulting in around 60 active ingredients having obtainednon-prescription status in some cases with a more restricted Summary of Product

Characteristics (SmPC) in at least one European country out of the 24 countries(mostly EU Member States) surveyed. It was clear that major differences still existacross European countries in relation to switches.

5.3 The analysis of non-prescription markets showed considerable differencesbetween European countries, both in terms of percentage market share of totalmedicines sales and in the development of those markets.

5.4 Regarding pricing and reimbursement, and distribution it can be seen that there isconsiderable variation in policy on accessibility of non-prescription medicines throughhealth systems, and the type of outlet where non-prescription medicines can bepurchased. Figure 1 provides an overview of the reimbursement regulations for non-prescription medicines. In most European countries reimbursement of non-prescription medicines is, in principle, possible, under certain specific restrictions. Butthere are some countries where non-prescription medicines are never reimbursed.This has implications for pricing, since in most European countries price control isusually only applicable for medicines which are reimbursed, whereas free pricing isapplied to non-reimbursable medicines.


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5.5 The research findings show no high-level correlation between distribution andreimbursement of non-prescription medicines, and the number of active ingredientsswitched and /or market share of non-prescription medicines. However, there appearto be some geographical patterns. For instance, the Mediterranean countries all havecomparably low market shares of non-prescription medicines even though distributionarrangements vary. For example, Greece and Spain have a strongly regulatedpharmacy sector, Italy allows the sale of non-prescription medicines from non-pharmacy outlets provided the sale is supervised and a pharmacist is on thepremises, and Portugal allows the sale of non-prescription medicines through non-pharmacy outlets without the need for the presence and supervision of a pharmacist.

5.6 From analysis of the non-prescription markets (using 2010 data or latest yearavailable), there appears to be no correlation between the size of the market and thenumber of substances switched to non-prescription status. For example, Italy, whichwas shown to have one of the largest numbers of substances reclassified (42), had


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one of the lowest market shares, whereas Czech Republic, which had a similarnumber of substances switched (37) had one of the largest market shares (32.4%).

Advertising and media communications

Advertising Regulatory Models

5.7 It is integral to self-care that manufacturers can communicate with consumers andhealthcare providers in a variety of ways to raise awareness of non-prescriptionmedicines in order to explain their purpose and health benefits, the conditions theyare intended to treat, and how to use them.

5.8 EU Directive 2001/83/EC allows advertising to the general public of non-prescription medicines in all media subject to certain conditions. In particular, theadvertising of products that contain psychotropic or narcotic substances is prohibited,

and Member States may prohibit the advertising of non-prescription products thatmay be reimbursed. Legislation prohibits misleading advertising and requires thatadvertising should be distinguishable from information.

5.9 An analysis of the rules in Member States for advertising and the provision of non-statutory information was undertaken in 2011 through a forum of Europeanadvertising regulators from 30 countries (all 27 EU Member States, Norway, Icelandand Croatia) which was convened by the UK [Ref 20]. The analysis revealed thatthere are different advertising regulatory models within Europe with both pre-and

post-event controls undertaken by either the state or through self-regulation by theindustry. Some Member States have different regulators and/or different regulatoryapproaches for advertising of non-prescription medicines in TV and radio comparedto print, and the requirements for advertising in these media are, in some cases, morerestrictive.

On-line networking and social media

5.10 Advertising regulators consider that, since the legislation specifies the contentand not the format of advertising, the principles for regulating on-line networking and

social media are the same as for other media, however the challenges are different.

5.11 The opportunities presented by these new media are being taken by bothadvertisers and regulators. Some innovative methods of advertising are emerging,such as sponsored apps on smart phones with pollen counts for hay fever sufferers,and the establishment of Twitter and Facebook accounts by national regulators forspeedy and effective dissemination of messages about medicines usage and safety.


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5.12 Specific challenges were identified, for example with use of Facebook, in relationto people posting comments on a site set up by a company. In some Member States,this would not be allowed; in others, companies would need to monitor all postingsand take responsibility for the information in them.

5.13 General media activity was seen by advertising regulators as having specificchallenges. Coverage of products in the media should be factual and balanced, andnot be designed to encourage the unnecessary use of the product. Advertisingregulators in some Member States are addressing this issue by developing guidelinesfor newspapers and medical writers.

Regulators perspectives on advertising of non-prescriptionmedicines

5.14 Regulators participating at a meeting of the forum of EU advertising regulatorsconsidered that advertising of non-prescription medicines is provided for in law andcompanies have a legitimate role in providing information about the existence of theirproducts. Moreover, they recognised that advertising has a role in improving accessto non-prescription medicines by raising awareness of the availability of a productwithout prescription and what it can be used for.

5.15 Self-regulation of advertising of non-prescription medicines is common in thenon-prescription medicines sector. Although self-regulatory codes are stronglysupported by the regulators, they consider that the legislation needs strict

enforcement by competent authorities.

5.16 Regulators considered that self-regulation is particularly effective where there isprior vetting of advertising material and/or competitor review of advertising, withcompanies in competition monitoring each others activities. However, theyconsidered that monitoring by companies is less effective in relation to gifts andverbal contact with health professionals, since these activities are not generallyobserved by competitors. Although these activities are more often linked to theprescription only medicines sector, they can exist in the advertising of non-prescription medicines. In the context of the European Commissions Corporate

Responsibility initiative in the field of pharmaceuticals, industry and otherstakeholders have agreed on a set of Guiding Principles for Ethics and Transparencyaddressing such concerns.

5.17 Additionally, people need access to authoritative information about non-prescription medicines and their uses, and in this respect competent authorities havea role to play. The EU pharmacovigilance legislation requires product information,


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SmPCs and Patient Leaflets (PLs), to be accessible from competent authorities.Patients and consumers need to be encouraged to use trustworthy sources ofinformation. Regulators participating at the meeting of the Forum of EU advertisingregulators considered that the development of the social media (Twitter andFacebook) provides the opportunity for competent authorities to communicate withthe public through an increasingly familiar medium, to provide information aboutpublic health and medicines, and to warn against incorrect information.

Education and Expectations of stakeholders

5.18 Recognising the importance of education in supporting access to non-prescription medicines, the Project Group undertook an analysis of the education andtraining of pharmacists and doctors throughout the EU on self-care and access tonewly reclassified non-prescription medicines. Consideration was also given to the

perspective of patients and consumers, focusing on their educational needs andexpectations.

Doctors training

5.19 In its survey of the education and training of doctors in self-care, CPME receivedresponses from 20 countries, 16 of which were EU Member States, and from Serbia,Iceland, Israel, Norway and Switzerland. Three of the countries (Norway, Iceland andGermany) did not respond to the questions since it was considered that in thesecountries, patients did not consult their doctor for minor ailments.

5.20 The survey revealed that self-care training programmes for doctors wereavailable in only two of the countries that responded. In most countries surveyed,education on self-care for minor ailments is already part of standard undergraduateand specialist training programmes for doctors. However, 9 countries did considerthat such training would be of interest and 9 agreed that it would relieve a doctorsworkload.

5.21 Doctors recognised in particular the importance of patient empowerment througheducation to ensure that people were able to decide when to seek advice from a

doctor when their condition was more serious. However, 12 survey respondentsforesaw a risk in this approach unless patient training programmes were designedcarefully. They considered that if the programme provided unsafe advice this couldlead to delay in medical treatment and aggravation of a patients health condition.Additionally they felt that it might alienate patients who already feel disconnected fromdoctors and medical advice especially those who would use their minor ailment asan excuse to consult a doctor about a more sensitive or embarrassing problem.


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5.22 The overall conclusion of CPME was that they did not see added value in settingup dedicated self-medication training programmes across all Member States, sincethis was in many cases covered in doctors basic training.

Pharmacists training

5.23 In a survey of the pre- and post-qualification education and training ofpharmacists in self-care and in supporting reclassification of medicines, the PGEUsent a questionnaire to 32 Liaison Secretaries (national representatives) of theEuropean Pharmacy Students Associations (EPSA).

5.24 The key findings of the analysis, based on data from 12 Member States, werethat therapeutics and clinical pharmacy are widely implemented in the pharmacyundergraduate course and in this respect there was no distinction betweenprescription and non-prescription medicines. Subjects such as clinical pharmacy,internal medicine, therapeutics and pharmaceutical care, which form part of themodern pharmacy curriculum, prepare the pharmacy workforce to respond effectivelyto patients seeking advice on self-medication and self-care. A specific approach tonon-prescription medicines as a category within the pharmacy curriculum isunnecessary.

5.25 The pharmacy profession does, however, recognise that communication andpatient counselling skills for self-care are different from those required forprescription-led pharmacy services. Communication and counselling skills are not

necessarily part of the pharmacists formal education; rather they are expected to beacquired both during the practice period, which is part of formal pharmacy training,and through pharmacy practice once qualified. While most pharmacists acquire theseskills in this way, PGEU considered that effective communication and counselingshould be an integral part of the pharmacy qualification in all EU Member States.

5.26 In addition, in all EU Member States pharmacists have a professional obligationto remain up-to-date in their practice, which they may do through organised orindividual continuing professional development activities. In some Member Statescontinuing education and/or continuing professional development is mandatory. Self-

care issues as well as training in effective communication are a part of theseactivities.

5.27 The role of meaningful continuing professional development is key, and essentialif communication and clinical skills are to be developed in the self-care context. Forexample, pharmacists are broadly in favour of following systematic approaches(guidelines, standard operating procedures, flow charts, etc) to interactions between


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themselves and patients when supplying non-prescription medicines, asdemonstrated in some countries with regard to, for example, emergency hormonalcontraception [Ref 21].

Patients/Consumers

5.28 People using non-prescription medicines have different levels of knowledge andunderstanding of self-medication and they need information and support to help themto make informed decisions about choosing and using self-care products, to helpthem identify the risks and the benefits associated with non-prescription medicines,and to enable them to engage in self-care to the degree with which they arecomfortable.

5.29 A person does not become truly informed just by being presented withinformation. While some people have the skills to identify authoritative informationsources, others may be overwhelmed and unable to distinguish between good andpoor information. Doctors and pharmacists have an important role to play in guidingpeople and helping them to find their way through the information jungle. Healthprofessionals also provide an important service in filtering the information so that itmeets the specific needs of an individual.

5.30 Helping and supporting people in self-care demands a significant investment intime from health professionals. Results of mystery shopping exercises conductedduring recent years by some consumer organisations in different EU Member States

showed that the information which consumers were given by pharmacists whenpurchasing non-prescription medicines was, in these cases, often inadequate.Patients expect health professionals and in particular pharmacists to be moreproactive in providing advice and comparative information on both treatment and non-treatment options, and in the detection of possible interactions with other medicines,herbal preparations, food supplements and foods.

Stakeholders views

5.31 A study was undertaken by EMINET to explore stakeholders views about the

switch climate in their country and their attitude to reclassification, non-prescriptionmedicines and self-care. Stakeholders interviewed included in the study were fromindustry, regulatory authorities, pharmacist associations, consumers and/or patientsassociations, doctors, researchers and public payers.


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5.32 The study showed that most stakeholders within Member States have a positiveattitude to non-prescription medicines and reclassification [Ref 22]. Overall, majorbenefits attributed to non-prescription medicines by the stakeholders interviewed are:

increased accessibility and quicker access to medicines;

no waiting times in doctors surgeries;

more therapeutic choice, particularly for minor ailments and;

freeing up doctors time to allow them to focus on patients with more seriousdiseases.

5.33 Another benefit identified by some interviewees is savings from public budgetswhen a medicine is no longer reimbursed after reclassification. This however would

mean some detriment for individual patients who have to support the cost of theirmedicines.

5.34 Regulators, in particular, identify safety as an important criterion in relation toreclassification although this was not the focus for all stakeholders as they trust thatauthorities will only reclassify a medicine in the case of a positive benefit-risk profile,and patients trust in the advice from pharmacists.

5.35 There are some concerns from stakeholders about patients not being sufficientlyinformed about non-prescription medicines and self-medication, and possibly not

having an appropriate consultation in the pharmacy.

5.36 Of particular concern to industry stakeholders are the costs and considerableefforts invested in reclassification and in supporting introduction into the market of anewly reclassified medicine, particularly considering the time limit of a 12 month dataexclusivity period in the EU.

5.37 From analysis of the sales of three reclassified active ingredients (pantoprazole,omeprazole, simvastatin) before and after reclassification [Ref 23] it was found thatwhile total sales of all presentations of the defined active ingredient showedincreases, there was no major growth in sales of the product that was actuallyswitched. In general, generic products (usually both prescription and non-prescription)gained market shares in a rather short period after market entry whereas thereclassified originators were commercially unsuccessful. In the case of pantoprazoleand simvastatin, growth in prescription sales could be attributed to the reclassificationcoinciding with patent expiry of the product. Regarding the non-prescription sales,


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these results illustrate the concerns of industry stakeholders and the existence of acommercial risk of some reclassifications for the industry.

5.38 A concern shared by different stakeholder groups in certain countries is the lossof reimbursement after reclassification, which is likely to lead to higher out-of-pocket

payments for the patient and/or may cause a shift to more expensive reimbursedmedicines prescribed by the doctor. Pharmacists raised concerns about non-prescription medicines being available from non-pharmacy outlets where nocounselling would be available from a health professional.

5.39 Stakeholders identified a number of enablers to promote reclassifications,including a supportive regulatory environment, a well-regulated pharmacy system andan environment in which patients are encouraged to take responsibility for their ownhealth, such as the UK Governments policy of encouraging self-care.

National initiatives to widen access to non-prescription medicines

5.40 In response to the need to address the issue of access to non-prescriptionmedicines, a number of Member States have or are undertaking national initiatives towiden access using a variety of approaches. These are detailed in Annex 5.

5.41 The Project Group considered that there was benefit in reviewing such initiativesand the current national legal frameworks for reclassifying a medicine fromprescription to non-prescription. This can help to further identify and develop solutions

to improving the reclassification environment and generate greater opportunities toincrease access to self-care products across the EU.

Best practice in improving access to non-prescription medicines

5.42 As part of its work programme the Project Group identified and discussed anumber of areas of best practice that related to improving access to non-prescriptionmedicines. These included initiatives or models of national best practices as well asspecific initiatives. Reviewing these examples and the current national legalframeworks for reclassifying a medicine from prescription only to non-prescription can

allow further identification of solutions to improve the reclassification environment inorder to generate greater opportunities for increasing consumer access to self-careproducts in the future. These national initiatives are detailed in Annex 6.


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6. Success factors, barriers and enablers to access to

non-prescription medicines

6.1 In considering the necessary elements to ensure availability, uptake, and

informed use and choice of non-prescription medicines, and thus achieve asuccessful reclassification, the work of the Group led to the identification of elementsneeded for a successful switch and of a number of barriers and enablers regardingaccess to non-prescription medicines.

Elements of a successful switch

6.2 Non-prescription medicines can empower patients if their availability coincideswith their condition, and with what they want, need and understand. For choice innon-prescription medicines to work, the public needs to be engaged, and health

professionals need skills and training to deliver impartial advice. Reclassification of amedicine from prescription to non-prescription does not in itself necessarily result inimproving access to that medicine.

6.3 In discussing solutions to the barriers and the issue of good governance andaccess to non-prescription medicines, the Project Group looked beyond theregulatory process and analysed the elements of a successful reclassification(switch). The Group considered what would be the favourable considerations forswitch and agreed that these should be based on the characteristics discussed indetail below.

Safety, ease of use and appropriate monitoring for switchedproducts

6.4 Pharmacovigilance evidence to establish an acceptable safety profile for amedicine is pivotal in any reclassification. No products are switched without a fullreview of their safety and a decision that they can safely be used for self-treatmentwithout medical intervention. Most safety data are gathered from experience of useof a medicine in the prescription setting. While the legislation regarding classification

of medicines is common in Europe, opinions on reclassification are often divergent,even with medicines for established self-care indications, the presentation andmanagement of which would, arguably, rarely differ between Member States.

6.5 The move to centralised pharmacovigilance monitoring gives Member States theadvantage of easier access to information about the safety in use of medicines thatare already available without prescription in other Member States. Thispharmacovigilance information could also help to inform Member States decisions on


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reclassification, alongside the considerations of their self-medication culture and thecharacteristics of their medicines distribution systems.

6.6 Ongoing monitoring of safety of non-prescription medicines in use is important notonly for those which are newly reclassified but also for well established products.

Appropriate and proportionate action has been taken by the regulators if there is newevidence to demonstrate a change in the safety or risk profile of a non-prescriptionmedicine, including evidence of misuse or abuse. Measures may include:

reducing pack size;

adding warnings to the label;

restricting supply to pharmacies, or;

reclassifying to prescription only.

6.7 Many researchers consider that misuse and abuse of non-prescription medicinesis not being picked up by the public or health professionals. Research amongpharmacists indicates that pharmacists perceive the abuse and misuse of some non-prescription medicines, particularly those containing opioids, antihistamines, andlaxatives, to be a problem [Ref 24]. The limited means to control and monitor non-prescription medicine use should be a consideration when a product is reclassifiedand as part of ongoing safety monitoring.

A clear beneficial impact on public health

6.8 The added value of the non-prescription use of a medicine, both for individualsand for the general population, should support the decision for the switch of a productfrom prescription only to non-prescription.

6.9 Benefit to public health can be demonstrated in different ways. For example, thedevelopment of non-communicable and chronic disease, such as obesity andsmoking related diseases, is an emerging public health threat. Empowering peopleto change behaviours and take steps to prevent the development of chronic disease,such as those related to smoking and obesity, for people who are not yet ill and whoare not visiting the doctor, can be supported by access to appropriate non-prescription medicines. Also, patients already suffering from non-communicable andchronic diseases should be better empowered through self-care, with assistance andadvice on a regular basis from their doctor and pharmacist where necessary.


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6.10 Self-care is also appropriate for the management of recurring conditions thathave already been first diagnosed by a doctor, with on-going health professionalsupport as required.

Responding to the needs and demands of citizens and healthprofessionals, in particular in terms of patient empowerment, timelyaccess, access to improved treatments and improved quality of life

6.11 Efficient, rapid and sustainable symptom relief will enable individuals to carry onwith their daily activities. This is particularly significant where quick access to a doctoris not always possible or where delay in treatment can make the condition worse. Ifsymptoms persist, clear warnings on the label and patient leaflet will encouragepeople to seek advice where there is a need subsequently to consult the doctor.

6.12 Advances in modern medicine, including in pharmacological profile, longerduration of action or fewer side effects, benefit all medicines takers. Where atherapeutic area or indication for self-care is well established and people areaccustomed to managing the conditions by themselves, there is benefit in makingbest use of advances in modern medicine in the range of non-prescription medicinesavailable.

6.13 It is important that health professionals are supported in their decision makingwhen responding to symptoms by evidence-based information and resources inrelation to the correct and appropriate use of non-prescription medicines. This is

particularly important when a medicine is newly reclassified.

6.14 Post-authorisation studies in the community and primary care setting may be anideal vehicle for providing ongoing evidence of use of non-prescription medicines inpractice and should be encouraged in justified cases.

Fulfilling unmet needs

6.15 For a number of reasons individuals sometimes suffer from conditions withoutconsulting a doctor. This might be because of concern about what might be an

unpleasant treatment, because they are embarrassed, because they consider thecondition to be too trivial or because they do not think there is a treatment for theirproblem and they just have to endure it. They may silently suffer from the condition,delaying a visit to the doctor until the situation becomes unbearable; they may alsoresort to seeking solutions on the internet leaving themselves vulnerable to accessingunproven treatments and counterfeit medicines and risking worsening theirconditions.


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6.16 Increasing access to medicines under these circumstances can result in bringingpeople into the healthcare system sooner and prevent damage to health caused by,for example the use of counterfeit medicines obtained via the internet.

Health professionals embracing the switch

6.17 Support by health professionals is important to ensure effective self-care andself-treatment and as a source of information, support and guidance on self-care. Therole of health professionals is also critical to the success of a switched product.

6.18 As people recognise and value the expertise of pharmacists and doctors thesehealth professionals have an important role to play in empowering people to take anactive role in their healthcare. The public expects that all the health professionalsthey encounter are working for the patients best interests and that doctors andpharmacists will collaborate. They expect consistent messages and to be giveninformation that they can understand and act upon. The cooperation of doctors andpharmacists is therefore very important to ensure that patients receive consistentinformation about the illness, not just the product and its contraindications, as well asinformation about when it is appropriate to use a non-prescription medicine and whenthey might need to see a doctor or other health professional.

6.19 Doctors are often unaware that a medicine has been reclassified even inMember States where the self-care culture is well developed. This can inhibit acollaborative approach to supporting patients who move between self-care and the

healthcare system.

Barriers to access to non-prescription medicines

Focus on risk only without consideration of public health benefit

6.20 The safety of all medicines is a key priority, and assessment of risk in the non-prescription setting is fundamental to reclassification of a medicine. However, thereare good examples of the value of improving access to a medicine where it is safe todo so, in terms of public health benefit.

6.21 The benefit-risk model for a non-prescription medicine will vary considerablybetween different medicinal products. There should be consideration of public healthbenefit as part of this model for each non-prescription medicine.


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All stakeholders have a common approach

6.32 Clear, consistent views and messages about the benefits and risks of a newlyreclassified medicine will contribute to a successful switch by increasing patientconfidence and ensuring responsible, safe and appropriate use.

Patients have access to information and advice

6.33 Patients need not only to be aware of a newly reclassified medicine but also tohave access to accurate and impartial information, which can be distinguished fromadvertising and promotional material, and health professional advice about theproduct and the therapeutic area for which it is indicated. This gives patients theconfidence and the skill to take advantage of availability of the medicine withoutprescription.

Patients are fully empowered by good education and support from healthprofessionals when needed

6.34 Patients who have good basic knowledge and understanding of how to look afterthemselves are well placed in general to understand where a newly reclassifiedmedicine fits into the area of self-care and will have the confidence to take advantageof its accessibility without the need for a prescription.

Education and involvement of pharmacists and doctors

6.35 Education and involvement of pharmacists and doctors is particularly importantfor innovative switches when a product with a new self-care indication becomesavailable without prescription, so that patients receive the support they need fromdoctors and pharmacists to use the product safely and effectively. Meaningfulcontinuing professional education should play a significant role in this process.

Economic viability

6.36 Economic viability includes an acceptable commercial return on investment ofthe switch for the manufacturer and an affordable price for the patient. From thepatient perspective, the price of a non-prescription medicine can interfere with thechoice to buy the product. When costs of medication become a barrier to its use, thepotential to support self-care is diminished. Switches should ideally not lead to healthinequalities or penalise people from low income groups.


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7.5 Key themes have emerged which are not part of the regulatory process for legalclassification and which have helped to identify factors that will contribute to goodgovernance of non-prescription medicines.

Focus on the benefits of medicines

7.6 While the safety of non-prescription medicines must remain a key priority whenreclassifying a medicine from prescription only to non-prescription, it is also importantthat the benefits, as well as the risks of non-prescription medicines are considered.The added value of the use of a medicine without prescription, both for individualsand for public health, should support a decision for the reclassification of a productfrom prescription only to non-prescription status. An understanding of the benefits aswell as the risks by health professionals and patients is also important so that theycan make informed choices about recommending and using non-prescription

medicines respectively. Examples of switches that have particularly demonstratedpublic health benefits are nicotine replacement therapy and emergency hormonalcontraception.

Safety, ease of use and appropriate monitoring for switchedproducts

7.7 Safety is a priority and a focus for all stakeholders and it is important that thesafety concerns of all stakeholders are met.

7.8 The EMA has already recognised the need for the development of tools to ensurea balanced benefit-risk assessment allowing different assessors and differentcompetent authorities to share benefit-risk analyses, which is an important step infurther encouraging an information and data-sharing culture among nationalregulators. This concept should be taken further by enabling the exchange ofinformation and experiences between those in competent authorities who areinvolved in the assessment of reclassification applications and encouraging thesharing of assessment reports.

7.9 It is also important to monitor how medicines are used in real life.

Pharmacovigilance monitoring gives Member States access to information about thesafety in use of medicines that are already available without prescription in otherMember States, to assure themselves that national switches elsewhere have not ledto an increase in adverse reactions. In some respects, real life use of medicines thathave been reclassified in some Member States can be regarded as pilots for otherMember States considering reclassifying that medicine. The EU pharmacovigilancelegislation provides the opportunity to enhance the monitoring of non-prescription


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medicines through patient reporting of suspected adverse reactions, greateropportunities for post authorisation safety and efficacy studies and risk managementplans to be put in place. Post authorisation studies in primary care could help gaininsight into the use in practice of non-prescription medicines.

Attitudes of stakeholders

7.10 The attitudes of stakeholders are a key factor in access to non-prescriptionmedicines. Among those countries surveyed, most stakeholders have a positiveattitude to non-prescription medicines and reclassification. There is wide recognitionamong all stakeholders that reclassification of medicines is a benefit to public healthas it:

enables quicker access to treatments, with no waiting times in doctorssurgeries

allows more therapeutic choice, particularly for minor ailments

frees up doctors time and

saves public health funds.

7.11 Safety is a key concern identified, particularly by regulators but also by healthprofessionals and by consumer representatives.

7.12 Patients expect pharmacists to support them in their decisions to choose anduse non-prescription medicines and in recognising when medical advice should besought, and they expect consistent advice from healthcare professionals. Differentattitudes and advice, particularly from pharmacists and doctors about self-medicationand use of non-prescription medicines can cause confusion and reduce publicconfidence in self-medication. Support from all health professionals is a key successfactor for a reclassification.

7.13 To facilitate a supportive attitude and common approach to non-prescriptionmedicines, the needs and concerns of all stakeholders must be met. Involvingpharmacists and doctors early in the process before switches take place would givethem the opportunity to raise those concerns and for those concerns to be addressedin a scientific and evidence-based way. Doctors main concerns are based onpossible risks of serious underlying conditions being missed. However, use of non-prescription medicines does not mean exclusion of the doctor in care pathways andthe development of collaborative care models between patients, pharmacists anddoctors will help identify and address safety concerns.


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7.14 Consulting with health professionals before a reclassification can also generateawareness of the switch under consideration and allows them to identify whatinformation or support materials may be needed to enable them to support patients in

the safe and effective use of the medicine.

7.15 There are good examples of collaborative care programmes with the support ofmedical professionals and pharmacists focusing on the education of patientsproducing positive clinical outcomes. (see Annex 6 on Best Practice.)

Education and training

7.16 Education of pharmacists and doctors in self-care is an important enabler forcollaborative care programmes and in supporting patients in general in their choice

and use of non-prescription medicines.

7.17 While in all Member States, pharmacists education and training equips themwith the required clinical and therapeutic knowledge, the pharmacy professionrecognises that effective communication and counselling should be an integral part ofpharmacy education in all Member States in order to meet patients expectations.

7.18 Self-care training programmes for doctors were available in only two of twentycountries surveyed. While the medical profession considered that education for self-care for minor ailments was already covered in the ordinary undergraduate and

specialist training programmes for doctors, doctor representatives in 9 countriesconsidered that a self-care training programme would be of benefit and 9 agreed thatit would relieve doctors workload.

7.19 Education of patients in self-care is also important. All stakeholders recognisethe importance of patient empowerment through education to ensure that people areable to decide when to self-treat and when to seek advice from a pharmacist or froma doctor when the condition is more serious. Education of patients in safe andresponsible self-care should be regarded as a life skill whose development should

start early. Basic education in schools will prepare the next generation for the future.Availability of high quality impartial information in a variety of forms will help tocontinue to develop an individuals knowledge of self-care. However, education andthe availability of information is only a supplement to the information and support thatpatients expect to receive from health professionals.


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Advertising and Information

7.20 Advertising of medicines, controlled by law in the EU, plays a key role inincreasing awareness among all stakeholders of the availability of a medicine withoutprescription. There is benefit in advertising regulators in Europe sharing information

about how advertising is regulated nationally.

7.21 It is recognised that advertising plays a role in increasing awareness amongstakeholders of the availability of a non-prescription medicine but it is important thatadvertising does not lead to confusion and that patients are able to distinguishbetween advertising and information.

7.22 Delivering information to patients is an integral part of health literacy and acornerstone for better health outcomes. Conversely, lack of information aboutproducts and self-care in general, and about illnesses that can be treated with self-medication, is a barrier to access to non-prescription medicines. All stakeholdershave a role to play in providing information to patients to support informed use andthe correct choice of non-prescription medicines andpeople need to be encouragedto use trustworthy sources of information.

7.23 Regulation requires manufacturers to provide accurate, high quality, user testedpatient information leaflets in the packs of authorised medicines. National CompetentAuthorities are required, through the EU pharmacovigilance legislation, to increasethe accessibility of regulated patient information i.e. SmPCs and Patient Leaflets, by

publishing them on their web-sites.

7.24 The Project Group has identified a number of examples of best practice wheregovernments, regulators and health professionals provide empowering information topatients and consumers, through self-care initiatives and programmes, and throughdedicated healthcare websites. However, as recognised by EU advertisingregulators, such initiatives require considerable resources, which are not available inall Member States. However, the development of the social media (Twitter andFacebook) provides the opportunity for national regulatory agencies to communicatewith the public through an increasingly familiar medium and in a cost effective way, to

provide information about public health and medicines, and to warn against incorrectinformation.

7.25 Health professionals also have an important role to provide face-to-face andwritten advice, which is greatly appreciated by patients and consumers. It isimportant that health professionals can access accurate and impartial informationabout non-prescription medicines to support them in their advisory role for patients.


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Economic viability

7.26 It is important to recognise the costs to industry and considerable effortsinvested in reclassification and in supporting the introduction into the market of a newreclassification in relation to the limit of a 12 month data exclusivity period in the EU.

As reclassifications are increasingly complex with the need for extensive educationaland risk management programmes it may be necessary to consider whether furtherincentives are needed to encourage manufacturers to undertake expensive switchprogrammes. In the United States and Japan a period of data exclusivity of threeyears for a reclassification is provided to incentivise research on self-care.

7.27 The commercial risk borne by manufacturers from innovative reclassification isdemonstrated in case studies undertaken for pantoprazole, omeprazole andsimvastatin which found that, while total sales of all presentations of these active

ingredients experienced increases following their reclassification, there was no majorgrowth in sales of the product that was actually switched.

7.28 The low uptake of reclassified products suggests a limited exploitation of thepublic health benefits of reclassification except for those cases of non-prescriptionavailability of generic versions. If reclassification becomes an unacceptablecommercial risk this could inhibit access to non-prescription medicines in the future.

Pricing and Reimbursement

7.29 Since national healthcare systems and reimbursement arrangements are anational competence, pricing and reimbursement policies related to non-prescriptionmedicines vary across the EU. However, improved access could be achieved if allstakeholders had a better understanding of the reclassification process and the rangeand nature of medicines available as non-prescription. It is important that it isunderstood that decisions to classify medicines as non-prescription are based onscientific evidence that they can be used safely without medical supervision and thatthere is no change in evidence of efficacy. Therefore, where reclassification to non-prescription results in that medicine no longer being reimbursed by the healthcaresystem there is no reason why doctors could not suggest the purchase of a non-

prescription medicine if that is the most appropriate treatment considering thepatients individual circumstances. This could be addressed through patientinformation and education, and with the support of health professionals. In 2004 theintroduction of the green prescription form in Germany following the de-reimbursement of non-prescription medicines allowed medical doctors to continueprescribing (for patients to purchase) non-prescription medicines that were no longer


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covered by the health insurance funds, signalling to patients that these were stilleffective and safe products.

7.30 Acknowledging the economic and public health benefits of self-medication, othercountries 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 bespent on non-prescription medicines) as part of the health insurance coverage.

7.31 Different pricing policies may also affect uptake of non-prescription medicines.For example, it may be a disincentive for people to purchase a non-prescriptionmedicine if it was cheaper to visit a doctor and obtain it on prescription. The inabilityto afford non-prescription medicines can create inequalities between the rich and thepoor regarding the right to practise self-care. The absence of pricing controls for non-

prescription medicines in Member States may play a role in reducing theseinequalities. In examining the pricing of non-reimbursed, non-prescription medicinesin 2007, the EU Commission and the EU Pharmaceutical Forum have alreadyadvised that Member States should abstain from price control for these products.

8. Recommendations

Elements of a successful switch

1. Recognising that there are many factors that affect access to non-prescriptionmedicines, Member States evaluating a reclassification should consider thefive elements of a successful switch:

a. Safety, ease of use and appropriate monitoring for switched products

b. A clear beneficial impact on public health

c. Responding to the needs/demands of citizens and health professionals, inparticular, in terms of patient empowerment, timely access, access to

improved treatments and improved quality of lifed. Fulfilling unmet needs and addressing conditions that would otherwise

remain untreated

e. Embraced by health professionals


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References

1.Bodenheimer, Patient Self-Management of Chronic Disease in Primary Care. 20022.WHO Guidelines for the regulatory assessment of medicinal products for Self Medication Copenhagen 1980s]3.PGEU survey on common pharmacist activities, 2011. ref. Joint FIP/WHO guidelines on goodpharmacy practice standards for quality of pharmacy services]4.Vogler et al.,OTC medicines: Switches of active ingredients in Europe in the last decade. EMINeT,20125.Vogler et al.,OTC medicines Distribution

6.Vogler et al., OTC medicines Framework of pricing and reimbursement, EMINeT, 20127.Figures based on information provided by AESGP membership, www.aesgp.eu/facts-figures/market-data/8.Development of an information policy for medicinal products,http://www.aesgp.eu/media/cms_page_media/68/FinalReport%20information%20policy.pdf, 2002.]9.Applicable marketing authorisation procedures:Centralised procedureThis procedure results in a single marketing authorisation that is valid in all European Union countries,as well as in Iceland, Liechtenstein and Norway. The European Medicines Agencyis responsible for

the centralised procedure and applications through the centralised procedure are submitted directly tothe Agency.Evaluation by the Agency's scientific committees takes up to 210 days, at the end of which thecommittee adopts an opinion on whether the medicine should be marketed or not. This opinion is thentransmitted to the European Commission, which has the ultimate authority for granting marketingauthorisations in the EU.Once a marketing authorisation has been granted, the marketing-authorisation holder can begin tomake the medicine available to patients and healthcare professionals in all EU countries.National proceduresMember States have national procedures for the authorisation of medicines within their territory. Thesefall outside the scope of the centralised procedure.Decentralised procedure (DCP)Companies can apply for the simultaneous authorisation in more than one EU country of a medicine

that has not yet been authorised in any EU country and that do not fall within the mandatory scope ofthe centralised procedure;Mutual-recognition procedure (MRP)Companies that have a medicine authorised in one EU Member State can apply for this authorisationto be recognised in other EU countries.10.Smart Regulation http://www.aesgp.eu/media/cms_page_media/18/SmartRegulation2015.pdf11.http://www.ema.europa.eu/ema/index.jsp?curl=pages/contacts/CHMP/people_listing_000080.j

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Promoting good governance for non-prescription medicines