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REPORT OF THE WORKING GROUP ONPROMOTING GOOD GOVERNANCE OFNON-PRESCRIPTION
DRUGS IN EUROPE 1
June 2013
1 The present document is without prejudice to any existing orfuture EU/ national and international legislation.
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Table of contents
1. Overview andContext..........................................................................................................3
2. Background..........................................................................................................................4
3. TheLandscape......................................................................................................................6
4. Methods and approaches of the Project Group..................................................................13
5. Findings from review ofevidence......................................................................................16
6. Success factors, barriers and enablers to access tonon-prescription medicines................25
7. Conclusions........................................................................................................................32
8. Recommendations..............................................................................................................38
9. Looking ahead....................................................................................................................41
References.................................................................................................................................42
Glossary.....................................................................................................................................45
Annex1......................................................................................................................................48
Annex2......................................................................................................................................54
Annex 3 Group Members.......................................................................................................59
Annex4......................................................................................................................................60
Annex 5 - National initiatives to widen access tonon-prescription medicines.........................73
Annex 6 - National Best Practiceexamples...........................................................................83
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1. Overview and Context
1.1 The healthcare environment is changing across the EU. Withan ageingpopulation and economic constraints on healthcare systemsthere is an increasedfocus on how to make best use of healthcareresources. Self-care has a role to play -in encouraging people totake more responsibility for their own health and wellbeing;makinghealthy life choices; consulting their doctor and or pharmacistswhereappropriate; and knowing if and when medical treatment shouldbe sought.
1.2 Patient behaviour is also changing across Member States,particularly with regardto growing empowerment in self-care, newroutes 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 theyconsider they do not needto consult a doctor, or which they maytreat after an initial medical diagnosis.Research [Ref 1] revealsthe positive effects of patient empowerment and self-management,and as healthcare moves closer to the patient, self-care hasthepotential to play an increasingly greater role in publichealth.
1.3 Over the years the practice of treating ailments withnon-prescription medicineshas developed as the importance ofself-care within healthcare systems has becomerecognised, and theprocess of reclassifying medicines from prescription only tonon-
prescription has progressed in some Member States to allow awider range oftreatments to be made available forself-medication[Ref 2].
1.4 Patient safety is a prime consideration in all aspects ofself-care, including in theregulation of non-prescription medicineswithin the EU. Robust evidence is required todemonstrate that amedicine can be used safely and appropriately withoutmedicalsupervision 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 moretreatments are
becoming available for conditions that have traditionally beenself-managed and asmedicines are reclassified to non-prescriptionwith new self-medication indications.
1.6 Recognising that legal status remains primarily a nationalcompetency there isconsiderable variability in availability ofnon-prescription medicines within the EU.Good governance ofnon-prescription medicines goes beyond the regulatory processand ispart of corporate social responsibility in a wider sense. Peopleshould be ableto look after themselves, and need the tools andsupport to do this. Governments,
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regulators, health professionals, patient and consumerrepresentatives, and non-prescription medicines manufacturers allhave a responsibility to ensure the correctmeasures are in place tofacilitate the availability and uptake ofnon-prescriptionmedicines, and their safe and responsible choiceand use.
1.7 The Project Group on Promoting Good Governance ofNon-prescriptionMedicines in the EU was one of the initiatives ofthe Platform on Access to Medicinesin Europe - a work area of theProcess on Corporate Responsibility in the Field ofPharmaceuticals.The Process was dedicated to enhancing collaboration amongMemberStates and all interested relevant stakeholders in order to findcommon, non-regulatory approaches to timely and equitable access tomedicines.The objective ofthe Project was to identify the necessaryelements to ensure availability, uptake, andinformed use and choiceof non-prescription medicines.
1.8 The Project was undertaken within a changing European legalenvironment inlight of the implementation of the revisedPharmacovigilance legislation,implementation of the FalsifiedMedicines Directive and plans for new legislation inrelation topatient information. Furthermore, it was recognised that theregulatoryenvironment for authorisation of medicinal products ischanging in relation to use ofthe centralised, mutual recognitionand decentralised procedures.
1.9 The Project investigated in particular the role of competentauthorities,pharmaceutical companies, consumers and patients, andhealth professionals infacilitating uptake and proper use ofnon-prescription medicines. All these
stakeholders were represented on the Project Group.
1.10 This Project Group offered a chance for all stakeholders tocome together andidentify measures needed to ensure that EUcitizens have access to non-prescriptionmedicines and are fullysupported to practise safe, effective and appropriateself-care.
2. Background
2.1 The European pharmaceutical sector is confronted today withmany challenges.
Due to the importance of medicinal products for the protectionof public health, it isnecessary to ensure that all partnersexercise their responsibilities in accordance withpublic health andsocietal needs. The Terms of Reference and the composition oftheProcess on Corporate Responsibility in the Field ofPharmaceuticals are provided inAnnex 1 to this report.
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2.2 The rationale for the Process on Corporate Responsibility inthe Field ofPharmaceuticals was not to be confined to oneobjective. 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 EUbasedpharmaceutical industry, and
III. enhance the role that patients can play in determining andaddressing theirmedical needs.
2.3 Due to the wide scope of the topics the following threeindependent 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 witha focus onAfrica.
2.4 Under the Platform on Access to Medicines in Europe thefollowing project groupswere put in place in order to give theparticipating stakeholders the opportunity toexchange ideas andknowledge, as well as to explore non-regulatory conditions that
may impact on access to medicines after their marketingauthorisation:
Mechanisms of coordinated access to orphan medicinalproducts
Capacity building on managed entry agreements for innovativemedicines
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 theclassification ofmedicines are both primarily nationalcompetencies, the extent to which self-care is
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practised and encouraged, and the range of medicines availablewithout prescription,as well as the circ*mstances under which theycan be accessed, varies widely acrossthe EU. Some countries havewell developed self-care systems and policies,enabling access to awide range of non-prescription medicines for acute andchronicconditions and for ill health prevention, as well as modelsof care within nationalhealth systems to encourage and empowerpeople to self-manage their conditionsunder the supervision of ahealth professional. Other countries have a morerestricted range ofnon-prescription medicines and self-care is limited to thetreatmentof minor self-limiting conditions. However, the situationis dynamic and, increasingly,national governments are looking athow self-care and self-medication can bettercontribute tohealthcare.
2.6 The Project Group on "Promoting good governance fornon-prescriptionmedicines" sought to gain a better understanding ofthe different approaches and
attitudes to availability and use of non-prescription medicinesacross the EU. TheGroup sought to identify the key factors thatcontribute to good access to non-prescription medicines in order toexplore common, non-regulatory approaches totimely access tonon-prescription medicines irrespective of national decisionsonclassification, and to provide a source of information forgovernments who wish totake national action to widen access tonon-prescription medicines while maintainingsafeguards to publichealth. The Terms of Reference for the Project Group are set outinAnnex 2.
3. The Landscape
The role of non-prescription medicines in self-care
3.1. Access to non-prescription medicines allows people to takea more active role inthe management of their own health and in thetreatment of common illnesses. Thesemedicines give people theresponsibility for caring for themselves until or unlessahealthcare providers expertise is necessary, and equips them withthe power to makea decision about their healthcare and to choosemedicines that meet their needs andconditions. When people cantreat common ailments themselves, it saves them time
and effort and can avoid a visit to the physician. Whereappropriate, non-prescriptionmedicines can also help individuals toself-treat embarrassing conditions that theyare not willing todiscuss with their doctor (see also 3.3).
3.2 While acknowledging that no medicine is risk-free, peoplebelieve fundamentallythat non-prescription medicines are safe andthat they do not usually have serious
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side effects: the relative safety is seen as being proportionalto the ease of access.Responsibility for safety is seen to bejointly held by the pharmaceutical industry andgovernment. Whenindividuals have a poor understanding of the nature ofnon-prescription medicines and how to use them, there are risks ofincorrect use, misuseor over consumption.
Patient empowerment
3.3 People want to have a more active role in their ownhealthcare, including in thedecisions about what medicines to take.When it comes to access to self-medication,good information andsupport translate into empowered patients who can benefit fullyfromthe opportunities of self-care and who can practise it safely andeffectively withinformed choice. As people take on greaterresponsibility for their healthcare, theneed grows to become betterinformed. It is important for people to have access to
high quality information from multiple sources and thatinformation is provided in avariety of formats to meet the needs ofdifferent patient groups.
3.4 Information on non-prescription medicines comes from a widerange of sources,starting with a clear and understandable label andpackage leaflet, and includingproduct websites and advertisem*nts.People are confronted with a growing volumeof information that isincreasingly personalised and interactive, and need to be abletomake sense of this in relation to their particular need andcondition. Additionally,advertising messages should be communicatedin a way that makes it clear that themessage is an advertisem*ntand the product concerned is identified as a medicine.
3.5 Health professionals are an important source of objectiveand balanced adviceabout medicines and their uses. Patientsunderstanding of the need to seekprofessional advice when necessarybefore buying a non-prescription medicine is partof health literacyand patient empowerment.
3.6 When considering wider access to non-prescription medicinesit is important totake into account the needs of people of varyinghealth education and literacy, toensure that they can read andunderstand 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 amedicine in accordance withthe instructions and seek advice wherenecessary from a health professional.
3.7 With regard to some non-prescription medicines, certainpopulation groupsincluding teenagers and people with drug addictionare particularly vulnerable. Somemedicines, such as painkillers canbe abused in intentional overdose while there is arisk of laxativeabuse by people with eating disorders. There is a risk of addictionto
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medicines containing codeine if they are not taken correctly.These risks need to bemanaged when considering widening access tonon-prescription medicines.
3.8 Misuse of non-prescription medicines can also pose risks tothe health of elderlypeople who are the largest consumers ofmedicines and are often on multiple
medicines. They are more vulnerable to adverse effects and tothe risks of multiple orinappropriate medications. They may startusing different non-prescription medicinesat the same time as theirprescribed medicines without informing their doctor; this cancauseadverse reactions that can remain undetected. Elderly people shouldbeencouraged to discuss with their pharmacist or doctor beforeusing different non-prescription medicines at the same time astheir prescribed medicines.
The important role played by health professionals
3.9 Within healthcare today there are increasing demands ondoctors time with anageing population requiring care for anincreasing number of chronic conditions andongoing economicrestraints on healthcare resources. Although responsibleself-carehelps to ensure that best possible use is made of adoctors time, it is essential thatpeople who choose toself-medicate are able to recognise when their condition maybe thesign of a more serious underlying disease, indicating that adiagnosis andmedical treatment are needed. Care should be taken toensure that access to non-prescription medicines does not lead toinappropriate self-medication and that non-prescription medicinesare used appropriately so that patients do not delay inseekingadvice from a doctor if they have a serious condition.Doctors play a key role in
supporting their patients in self-care and in ensuring informeduse and proper choiceof non-prescription medicines by the patient.In particular, they can reassure patientsif they are worried abouta minor condition on which they are seeking advice andeducate theirpatients by explaining in certain circ*mstances, why they couldhavepurchased a medicine in a pharmacy.
3.10 The role of the pharmacist has evolved in healthcaresystems. Pharmacistsexpert knowledge of medicines is wellrecognised and a broad range of pharmacyservices and more complexinterventions in relation to medicines use and publichealth areavailable from pharmacies across the EU.
3.11 Supporting self-care is recognised by pharmacists in allMember States as beinga core activity of the profession [Ref 3].Widely distributed in Europe and easilyaccessible pharmacists areoften the first and sometimes the only health professionalto assista patient in their self-care journey, in:
advising on the management of symptoms;
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providing advice on maintaining good health and avoidingillness, and;
selecting the most appropriate medication.
3.12 Pharmacists also have an important role to play inencouraging people to read
the label and patient leaflet and in reinforcing the informationto ensure safe andeffective use of non-prescription medicines,particularly when there is a risk ofincorrect use or abuse. This isespecially important with newly reclassified medicines.
3.13 In addition, pharmacists play an important role insignposting patients byreferring them to the doctor or anotherappropriate health service when medicalexamination or prescriptiontreatment is considered necessary.
Variability of access
3.14 Non-prescription status is the natural classification for amedicine according toEU legislation. The range of non-prescriptionmedicines available can include not onlymedicines to treat acuteshort term self-limiting conditions, but also medicines forchronicdisease management and disease prevention.
3.15 However, there is great diversity in the number and type ofmedicines that areavailable without prescription across the EU.Specifically, according to a surveybased on primary data collectedby the Association of the European Self-MedicationIndustry (AESGP),as of January 2011 there were only 5 molecules (see section 7)thatare available in some form without prescription in 24 Europeancountries, and 10molecules that are available without prescriptionin 22 European countries (mainly EUMember States) [Ref4].Variability between Member States is related not only tothenumber of non-prescription medicines available, but also to therange of ailments forwhich non-prescription medicines can beaccessed.
Diversity of approaches
See AlsoInhibition of STAT3 in gastric cancer: role of pantoprazole as SHP-1 inducer | Article Information | J-GLOBALTraditional Advance Directives Undermine Advance Care Planning3.16 While there is a common medicines regulatory framework inthe EU, there is adiversity of approaches between Member States tocontrolling access to non-
prescription medicines, including different national decisionson 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 differentapproaches tothe limits for conditions of use for anon-prescription medicine so even if a substanceis availablewithout prescription in a number of Member States, there maybedifferences in relation to, for example, the indications,treatment population, dose,strength, contraindications, andavailable pack sizes of medicines.
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3.17 Member States also have different national policies ondistribution of non-prescription medicines, ranging from restrictedavailability from pharmacies only, towider access in supermarketsand other outlets, as well as via the internet with orwithout thesupervision of a pharmacist [Ref 5].
3.18 There are also different approaches to reimbursem*nt andpricing [Ref 6]. Insome Member States, reclassification tonon-prescription will result in a product nolonger being reimbursedby national health insurance systems. Pricing policies alsodifferbetween countries, with free pricing on non-prescription medicinesbeing inplace in some countries, particularly if medicines are notreimbursed.
Industry and innovation
The non-prescription medicines market
3.19 Half of all medicines sold in the EU have anon-prescription status and over100,000 non-prescription medicinesare estimated to be produced and marketed bymulti-national as wellas many small and medium enterprises. The market in the EUin 2011was estimated to be in the area of 27 billion Euro, orapproximately 15% ofthe total pharmaceutical market [Ref 7]. Theshare of sales of non-prescriptionmedicines in various Europeancountries differs considerably.
Innovation in the non-prescription medicines market
3.20 People have always used non-prescription medicines to dealwith conditionssuch as headache, upset stomach, hay fever, coldsores, and diarrhoea. Innovationin the self-care market hasresulted in people now being in a position to treat theseconditionswith modern, clinically proven medicines. For example, whereas oncetheonly way to treat excess gastric acid was through use of anantacid, now people canuse alginate rafting agents to stop refluxor use H2-antagonists or proton pumpinhibitors (PPI) to reduce acidlevels. New self-medication products are usuallydeveloped initiallyfor supply on the basis of a prescription by a doctor andaresubsequently reclassified as non-prescription medicines based ontheir establishedsafety profile and potential for effective andsafe use as such.
3.21. Innovation in self-care does not only concern newingredients in non-prescription medicines, but also the indicationsthat are considered suitable for self-management. vagin*l thrush,irritable bowel syndrome, high cholesterol, benignprostatichyperplasia-related urinary symptoms, migraine, eczema andevenemergency contraception are now all accepted in certainEuropean markets asconditions for self-management. In an EU-fundedresearch project [Ref 8] the
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AESGP analysed the potential for innovation in the provision ofcare, examining howindividuals can take on a greater role in themanagement of their health with theintroduction of new indicationsfor self-care. Possible self-care indications identifiedin thisproject ranged from the treatment of acute and chronic conditionsthat can beself-diagnosed, to those that would require a doctorconsultation and/or healthprofessional advice before they could beself-managed.
The environment in which industry operates - How productsreachthe market
National and European authorisation of non-prescriptionmedicines
3.22 Every non-prescription medicine on the European market hasbeen assessed forsafety and efficacy before it reaches the marketand is continually monitored forsafety while it is marketed[Ref 9].The same strict regulatory framework is used forboth prescriptionand non-prescription medicines and when prescription medicinesarebeing evaluated for suitability for non- prescription status. Thisensures thatcitizens in Europe have access to safe and effectiveproducts of high quality. Thechange of legal status fromprescription to non-prescription (switch) is addressed byArticle 74of Directive 2001/83/EC and explained in the Commission guidelineonchanging the classification for the supply of a medicinal productfor human use(rev.January 2006).
3.23 Most non-prescription medicines have national marketingauthorisations issued
by national competent health authorities which are valid only inthe country in whichthey were issued. An increasing number of newprescription-only products areauthorised centrally by the EuropeanCommission to be marketed across the EU. Theuse of the centralisedprocedure for the authorisation of non-prescriptionmedicines,however, has so far been limited, with 5 applications and2 positive opinions to date(pantoprazole for short-term treatmentof reflux symptoms in adults and orlistat forweight loss in adultswith BMI of 28 or over). Moreover, if an application for acentrallyauthorised product to be classified as non-prescriptionthrough the centralisedprocedure has been unsuccessful, it is notpossible subsequently to submit anapplication for a nationalmarketing authorisation for an identical product even whenallnational requirements for the marketing authorisation are met.
3.24 The centralised procedure ensures availability ofnon-prescription medicinesthroughout the EU. The Decentralised andMutual Recognition procedures allownational products to be marketedacross a number of European Member States. Theuse of theseprocedures for non-prescription medicines has beendisproportionately
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low compared with the respective marketing authorizationapplications for prescriptiononly medicines.
3.25 As science, the practice of medicine and peoples ability toself-treat evolve andgrow, industry is interested in increasingEuropean citizens access to self-care with
existing products, and by expanding the types ofnon-prescription therapies. The non-prescription industry aims atproviding the same high quality and safe products to theentire EUmarket. However, different interpretations of the Europeanlegislation haveled to major differences in the range ofnon-prescription medicines available indifferent Member States.Companies operating in Europe through the Association oftheEuropean Self-Medication Industry (AESGP) have set out a programmeforchange to address the barriers to an efficient regulatoryenvironment [Ref 10].
3.26 Member States across the EU carrying out their ownassessments of safety and
efficacy are aware of the need to address differences in the wayregulations andguidelines are interpreted and applied throughoutEurope. Platforms such as theEuropean Medicines Agencys (EMA)Co-ordination Group [Ref 11] and theCoordination Group for theMutual Recognition and Decentralised procedures(CMDh) [Ref 12]provide forums for regulators to effectively addressthesedifferences.
3.27 As the need for consistency and transparency in decisionmaking for allmedicines at both EU and national levels has beenuniversally accepted, the EMAhas launched a project on benefit-riskassessment to work in this direction [Ref 13].
At the same time, the non-prescription industry is also engagedwith regulators andacademics in an open dialogue on how to ensurean appropriate benefit-riskassessment to fully take into accountthe specificities of non-prescription medicines.A proposal for anew benefit-risk model, specially adapted tonon-prescriptionmedicines, has been published by independentresearchers [Ref 14].
3.28 This benefit-risk assessment model for non-prescriptionmedicines has at itsheart stakeholder engagement and communication.It aims to develop a commonapproach to the assessment ofnon-prescription medicines at different stages: whenthey are firstput on the market, when they are evaluated for non-prescriptionstatusand when their safety is monitored post-marketing.
3.29 Worldwide, few non-prescription medicines are protected bypatents, butgovernments have recognised the need to provide otherincentives to encourageinnovation. The EU pharmaceuticallegislation (Directive 2001/83/EC) provides fordata exclusivity inthe case of applications for new indications forwell-establishedsubstances, when these result from significantpre-clinical or clinical studies having
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been carried out by the applicant [Ref 15]. Similarly, aone-year data exclusivityperiod can be given in the EU in the caseof re-classification of a medicine fromprescription only tonon-prescription status [Ref 16]if this results from significantpre-clinical tests or clinical trials carried out by the marketingauthorisationholder/applicant.
Pricing
3.30 Whereas Member States usually control the prices ofprescription onlymedicines supplied under national healthcaresystems, no price control measuresapply for non-reimbursednon-prescription medicines in the majority of EU MemberStates. Thepricing of non-reimbursed medicines was examined by theEuropeanCommission and the EU Pharmaceutical Forum in 2007, whichconcluded that pricecontrol is not necessary for non-reimbursedmedicines. For these products, price
competition can steer the price evolution sufficiently well[Ref17].
3.31 The consumer healthcare sector represents a competitivemarket, with strongcompetition not only between non-prescriptionmedicines, but also from products ofother categories (e.g. medicaldevices, cosmetics, food supplements). Thereforepricing policy fornon-prescription medicines is a determining factor for ensuringthefunctioning of a competitive market where manufacturers areincentivised to innovateand offer citizens the best value at anacceptable 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 accessto non-prescription
medicines across Member States2) To identify examples of howaccess to non-prescription medicines can supportpatients to takeshared responsibility for their own health care
3) To identify medicines where non-prescription access has thepotential to have asignificant impact on public health and toconsider what may be learnt fromexperience of successful andunsuccessful 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-prescriptionmedicines.
pricing and reimbursem*nt issues
5) To explore health professional and patient attitudes and whatmay support aproactive and supportive approach to self-care.
Membership of the Group
4.2 The Project Group was co chaired by the UK Medicines andHealthcare productsRegulatory Agency (MHRA) and the EuropeanCommission. The membership of theProject Group comprisedrepresentatives from competent authorities,pharmaceuticalcompanies, consumers and patients, and healthprofessionals. The Commissioninvited representatives from allMember 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 thosewho participated in the ProjectGroup is at Annex 3.
Work plan
4.3 The Project Groups work was developed and coordinatedthrough 12teleconferences and four face-to-face meetings two heldin Brussels and one eachin Copenhagen and London. The Group agreeda work plan detailing various workstreams, and the methodology andactions required to deliver the work areas
covered. All members of the Group contributed significantly tothe delivery of the workplan. Individual members took the lead ondifferent items, with input and support fromthe rest of the Group.Considerable work was undertaken by group members inbetween contacttimes, collating information and exploring issues based ontheirexperiences and expertise. Face to face meetings were used toshare informationgathered, exchange views, and discuss and agree onthe main recommendations.
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4.4 Work topics included:
An analysis of the factors that contribute to successful andunsuccessfulavailability, uptake and informed use of a medicineafter it has beenreclassified
An historical overview of the development of thenon-prescription medicinessector
An overview of studies examining the positive economic impact ofself-care inEU Member States
Analysis of case histories of availability and uptake ofnon-prescriptionmedicines following reclassification, and of theimpact of switches.
A review and study of the attitudes and experiences of patientsand healthprofessionals to non-prescription medicines and self-careacross the EU
An analysis of the education and training of healthprofessionals to supportself-care and uptake of newly reclassifiednon-prescription medicines
An analysis of rules in Member States for advertising andprovision of non-statutory information
A collation of national initiatives within Member States toimprove access to
non-prescription medicines. Contributions were received from allMemberStates represented on the Group.
4.5 To support the work of the Group, the European MedicinesInformation Network(EMINeT) [Ref 18] was commissioned to map (Annex4) the landscape of non-prescription medicines and reclassificationacross 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 reimbursem*nt regulation for OTC medicines in theEU
4.6 EMINet was also commissioned to undertake a stakeholdersurvey in Europeancountries in order to identify the barriers andsupporting 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 [Ref4,5,6,19]revealed a diversityof systems and approaches to theregulation, and access to market, of non-prescription medicines inMember States.
5.2 The analysis of switches of medicines or substances fromprescription only tonon-prescription showed that a number ofswitches have been undertaken in severalcountries in the lastdecade, resulting in around 60 active ingredients havingobtainednon-prescription status in some cases with a morerestricted Summary of Product
Characteristics (SmPC) in at least one European country out ofthe 24 countries(mostly EU Member States) surveyed. It was clearthat major differences still existacross European countries inrelation to switches.
5.3 The analysis of non-prescription markets showed considerabledifferencesbetween European countries, both in terms of percentagemarket share of totalmedicines sales and in the development ofthose markets.
5.4 Regarding pricing and reimbursem*nt, and distribution it canbe seen that there isconsiderable variation in policy onaccessibility of non-prescription medicines throughhealth systems,and the type of outlet where non-prescription medicines canbepurchased. Figure 1 provides an overview of the reimbursem*ntregulations for non-prescription medicines. In most Europeancountries reimbursem*nt of non-prescription medicines is, inprinciple, possible, under certain specific restrictions. Butthereare some countries where non-prescription medicines are neverreimbursed.This has implications for pricing, since in mostEuropean countries price control isusually only applicable formedicines which are reimbursed, whereas free pricing isapplied tonon-reimbursable medicines.
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5.5 The research findings show no high-level correlation betweendistribution andreimbursem*nt of non-prescription medicines, andthe number of active ingredientsswitched and /or market share ofnon-prescription medicines. However, there appearto be somegeographical patterns. For instance, the Mediterranean countriesall havecomparably low market shares of non-prescription medicineseven though distributionarrangements vary. For example, Greece andSpain have a strongly regulatedpharmacy sector, Italy allows thesale of non-prescription medicines from non-pharmacy outletsprovided the sale is supervised and a pharmacist is on thepremises,and Portugal allows the sale of non-prescription medicines throughnon-pharmacy outlets without the need for the presence andsupervision of a pharmacist.
5.6 From analysis of the non-prescription markets (using 2010data or latest yearavailable), there appears to be no correlationbetween the size of the market and thenumber of substances switchedto non-prescription status. For example, Italy, whichwas shown tohave one of the largest numbers of substances reclassified (42),had
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one of the lowest market shares, whereas Czech Republic, whichhad a similarnumber of substances switched (37) had one of thelargest market shares (32.4%).
Advertising and media communications
Advertising Regulatory Models
5.7 It is integral to self-care that manufacturers cancommunicate with consumers andhealthcare providers in a variety ofways to raise awareness of non-prescriptionmedicines in order toexplain their purpose and health benefits, the conditions theyareintended to treat, and how to use them.
5.8 EU Directive 2001/83/EC allows advertising to the generalpublic of non-prescription medicines in all media subject tocertain conditions. In particular, theadvertising of products thatcontain psychotropic or narcotic substances is prohibited,
and Member States may prohibit the advertising ofnon-prescription products thatmay be reimbursed. Legislationprohibits misleading advertising and requires thatadvertisingshould be distinguishable from information.
5.9 An analysis of the rules in Member States for advertisingand the provision of non-statutory information was undertaken in2011 through a forum of Europeanadvertising regulators from 30countries (all 27 EU Member States, Norway, Icelandand Croatia)which was convened by the UK [Ref 20]. The analysis revealedthatthere are different advertising regulatory models within Europewith both pre-and
post-event controls undertaken by either the state or throughself-regulation by theindustry. Some Member States have differentregulators and/or different regulatoryapproaches for advertising ofnon-prescription medicines in TV and radio comparedto print, andthe 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 legislationspecifies the contentand not the format of advertising, theprinciples for regulating on-line networking and
social media are the same as for other media, however thechallenges are different.
5.11 The opportunities presented by these new media are beingtaken by bothadvertisers and regulators. Some innovative methods ofadvertising are emerging,such as sponsored apps on smart phoneswith pollen counts for hay fever sufferers,and the establishment ofTwitter and Facebook accounts by national regulators forspeedy andeffective dissemination of messages about medicines usage andsafety.
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5.12 Specific challenges were identified, for example with useof Facebook, in relationto people posting comments on a site set upby a company. In some Member States,this would not be allowed; inothers, companies would need to monitor all postingsand takeresponsibility for the information in them.
5.13 General media activity was seen by advertising regulatorsas having specificchallenges. Coverage of products in the mediashould be factual and balanced, andnot be designed to encourage theunnecessary use of the product. Advertisingregulators in someMember States are addressing this issue by developing guidelinesfornewspapers and medical writers.
Regulators perspectives on advertising ofnon-prescriptionmedicines
5.14 Regulators participating at a meeting of the forum of EUadvertising regulatorsconsidered that advertising ofnon-prescription medicines is provided for in law andcompanies havea legitimate role in providing information about the existence oftheirproducts. Moreover, they recognised that advertising has arole in improving accessto non-prescription medicines by raisingawareness of the availability of a productwithout prescription andwhat it can be used for.
5.15 Self-regulation of advertising of non-prescriptionmedicines is common in thenon-prescription medicines sector.Although self-regulatory codes are stronglysupported by theregulators, they consider that the legislation needs strict
enforcement by competent authorities.
5.16 Regulators considered that self-regulation is particularlyeffective where there isprior vetting of advertising materialand/or competitor review of advertising, withcompanies incompetition monitoring each others activities. However,theyconsidered that monitoring by companies is less effective inrelation to gifts andverbal contact with health professionals,since these activities are not generallyobserved by competitors.Although these activities are more often linked to theprescriptiononly medicines sector, they can exist in the advertising ofnon-prescription medicines. In the context of the EuropeanCommissions Corporate
Responsibility initiative in the field of pharmaceuticals,industry and otherstakeholders have agreed on a set of GuidingPrinciples for Ethics and Transparencyaddressing such concerns.
5.17 Additionally, people need access to authoritativeinformation about non-prescription medicines and their uses, and inthis respect competent authorities havea role to play. The EUpharmacovigilance legislation requires product information,
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SmPCs and Patient Leaflets (PLs), to be accessible fromcompetent authorities.Patients and consumers need to be encouragedto use trustworthy sources ofinformation. Regulators participatingat the meeting of the Forum of EU advertisingregulators consideredthat the development of the social media (Twitter andFacebook)provides the opportunity for competent authorities to communicatewiththe public through an increasingly familiar medium, to provideinformation aboutpublic health and medicines, and to warn againstincorrect information.
Education and Expectations of stakeholders
5.18 Recognising the importance of education in supportingaccess to non-prescription medicines, the Project Group undertookan analysis of the education andtraining of pharmacists and doctorsthroughout the EU on self-care and access tonewly reclassifiednon-prescription medicines. Consideration was also given to the
perspective of patients and consumers, focusing on theireducational needs andexpectations.
Doctors training
5.19 In its survey of the education and training of doctors inself-care, CPME receivedresponses from 20 countries, 16 of whichwere EU Member States, and from Serbia,Iceland, Israel, Norway andSwitzerland. Three of the countries (Norway, Iceland andGermany)did not respond to the questions since it was considered that inthesecountries, patients did not consult their doctor for minorailments.
5.20 The survey revealed that self-care training programmes fordoctors wereavailable in only two of the countries that responded.In most countries surveyed,education on self-care for minorailments is already part of standard undergraduateand specialisttraining programmes for doctors. However, 9 countries didconsiderthat such training would be of interest and 9 agreed thatit would relieve a doctorsworkload.
5.21 Doctors recognised in particular the importance of patientempowerment througheducation to ensure that people were able todecide when to seek advice from a
doctor when their condition was more serious. However, 12 surveyrespondentsforesaw a risk in this approach unless patient trainingprogrammes were designedcarefully. They considered that if theprogramme provided unsafe advice this couldlead to delay in medicaltreatment and aggravation of a patients healthcondition.Additionally they felt that it might alienate patientswho already feel disconnected fromdoctors and medical adviceespecially those who would use their minor ailment asan excuse toconsult a doctor about a more sensitive or embarrassingproblem.
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5.22 The overall conclusion of CPME was that they did not seeadded value in settingup dedicated self-medication trainingprogrammes across all Member States, sincethis was in many casescovered in doctors basic training.
Pharmacists training
5.23 In a survey of the pre- and post-qualification educationand training ofpharmacists in self-care and in supportingreclassification of medicines, the PGEUsent a questionnaire to 32Liaison Secretaries (national representatives) of theEuropeanPharmacy Students Associations (EPSA).
5.24 The key findings of the analysis, based on data from 12Member States, werethat therapeutics and clinical pharmacy arewidely implemented in the pharmacyundergraduate course and in thisrespect there was no distinction betweenprescription andnon-prescription medicines. Subjects such as clinicalpharmacy,internal medicine, therapeutics and pharmaceutical care,which form part of themodern pharmacy curriculum, prepare thepharmacy workforce to respond effectivelyto patients seeking adviceon self-medication and self-care. A specific approachtonon-prescription medicines as a category within the pharmacycurriculum isunnecessary.
5.25 The pharmacy profession does, however, recognise thatcommunication andpatient counselling skills for self-care aredifferent from those required forprescription-led pharmacyservices. Communication and counselling skills are not
necessarily part of the pharmacists formal education; ratherthey are expected to beacquired both during the practice period,which is part of formal pharmacy training,and through pharmacypractice once qualified. While most pharmacists acquire theseskillsin this way, PGEU considered that effective communication andcounselingshould be an integral part of the pharmacy qualificationin all EU Member States.
5.26 In addition, in all EU Member States pharmacists have aprofessional obligationto remain up-to-date in their practice,which they may do through organised orindividual continuingprofessional development activities. In some MemberStatescontinuing education and/or continuing professionaldevelopment is mandatory. Self-
care issues as well as training in effective communication are apart of theseactivities.
5.27 The role of meaningful continuing professional developmentis key, and essentialif communication and clinical skills are to bedeveloped in the self-care context. Forexample, pharmacists arebroadly in favour of following systematic approaches(guidelines,standard operating procedures, flow charts, etc) to interactionsbetween
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themselves and patients when supplying non-prescriptionmedicines, asdemonstrated in some countries with regard to, forexample, emergency hormonalcontraception [Ref 21].
Patients/Consumers
5.28 People using non-prescription medicines have differentlevels of knowledge andunderstanding of self-medication and theyneed information and support to help themto make informed decisionsabout choosing and using self-care products, to helpthem identifythe risks and the benefits associated with non-prescriptionmedicines,and to enable them to engage in self-care to the degreewith which they arecomfortable.
5.29 A person does not become truly informed just by beingpresented withinformation. While some people have the skills toidentify authoritative informationsources, others may beoverwhelmed and unable to distinguish between good andpoorinformation. Doctors and pharmacists have an important role to playin guidingpeople and helping them to find their way through theinformation jungle. Healthprofessionals also provide an importantservice in filtering the information so that itmeets the specificneeds of an individual.
5.30 Helping and supporting people in self-care demands asignificant investment intime from health professionals. Results ofmystery shopping exercises conductedduring recent years by someconsumer organisations in different EU Member States
showed that the information which consumers were given bypharmacists whenpurchasing non-prescription medicines was, in thesecases, often inadequate.Patients expect health professionals and inparticular pharmacists to be moreproactive in providing advice andcomparative information on both treatment and non-treatmentoptions, and in the detection of possible interactions with othermedicines,herbal preparations, food supplements and foods.
Stakeholders views
5.31 A study was undertaken by EMINET to explore stakeholdersviews about the
switch climate in their country and their attitude toreclassification, non-prescriptionmedicines and self-care.Stakeholders interviewed included in the study were fromindustry,regulatory authorities, pharmacist associations, consumers and/orpatientsassociations, doctors, researchers and public payers.
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5.32 The study showed that most stakeholders within MemberStates have a positiveattitude to non-prescription medicines andreclassification [Ref 22]. Overall, majorbenefits attributed tonon-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 ailmentsand;
freeing up doctors time to allow them to focus on patients withmore seriousdiseases.
5.33 Another benefit identified by some interviewees is savingsfrom public budgetswhen a medicine is no longer reimbursed afterreclassification. This however would
mean some detriment for individual patients who have to supportthe cost of theirmedicines.
5.34 Regulators, in particular, identify safety as an importantcriterion in relation toreclassification although this was not thefocus for all stakeholders as they trust thatauthorities will onlyreclassify a medicine in the case of a positive benefit-riskprofile,and patients trust in the advice from pharmacists.
5.35 There are some concerns from stakeholders about patientsnot being sufficientlyinformed about non-prescription medicines andself-medication, and possibly not
having an appropriate consultation in the pharmacy.
5.36 Of particular concern to industry stakeholders are thecosts and considerableefforts invested in reclassification and insupporting introduction into the market of anewly reclassifiedmedicine, particularly considering the time limit of a 12 monthdataexclusivity period in the EU.
5.37 From analysis of the sales of three reclassified activeingredients (pantoprazole,omeprazole, simvastatin) before and afterreclassification [Ref 23] it was found thatwhile total sales of allpresentations of the defined active ingredient showedincreases,there was no major growth in sales of the product that wasactuallyswitched. In general, generic products (usually bothprescription and non-prescription)gained market shares in a rathershort period after market entry whereas thereclassified originatorswere commercially unsuccessful. In the case of pantoprazoleandsimvastatin, growth in prescription sales could be attributed tothe reclassificationcoinciding with patent expiry of the product.Regarding the non-prescription sales,
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these results illustrate the concerns of industry stakeholdersand the existence of acommercial risk of some reclassifications forthe industry.
5.38 A concern shared by different stakeholder groups in certaincountries is the lossof reimbursem*nt after reclassification, whichis likely to lead to higher out-of-pocket
payments for the patient and/or may cause a shift to moreexpensive reimbursedmedicines prescribed by the doctor. Pharmacistsraised concerns about non-prescription medicines being availablefrom non-pharmacy outlets where nocounselling would be availablefrom a health professional.
5.39 Stakeholders identified a number of enablers to promotereclassifications,including a supportive regulatory environment, awell-regulated pharmacy system andan environment in which patientsare encouraged to take responsibility for their ownhealth, such asthe UK Governments policy of encouraging self-care.
National initiatives to widen access to non-prescriptionmedicines
5.40 In response to the need to address the issue of access tonon-prescriptionmedicines, a number of Member States have or areundertaking national initiatives towiden access using a variety ofapproaches. These are detailed in Annex 5.
5.41 The Project Group considered that there was benefit inreviewing such initiativesand the current national legal frameworksfor reclassifying a medicine fromprescription to non-prescription.This can help to further identify and develop solutions
to improving the reclassification environment and generategreater opportunities toincrease access to self-care productsacross the EU.
Best practice in improving access to non-prescriptionmedicines
5.42 As part of its work programme the Project Group identifiedand discussed anumber of areas of best practice that related toimproving access to non-prescriptionmedicines. These includedinitiatives or models of national best practices as well asspecificinitiatives. Reviewing these examples and the current nationallegalframeworks for reclassifying a medicine from prescription onlyto non-prescription can
allow further identification of solutions to improve thereclassification environment inorder to generate greateropportunities for increasing consumer access to self-careproductsin the future. These national initiatives are detailed in Annex6.
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6. Success factors, barriers and enablers to access to
non-prescription medicines
6.1 In considering the necessary elements to ensureavailability, uptake, and
informed use and choice of non-prescription medicines, and thusachieve asuccessful reclassification, the work of the Group led tothe identification of elementsneeded for a successful switch and ofa number of barriers and enablers regardingaccess tonon-prescription medicines.
Elements of a successful switch
6.2 Non-prescription medicines can empower patients if theiravailability coincideswith their condition, and with what theywant, need and understand. For choice innon-prescription medicinesto work, the public needs to be engaged, and health
professionals need skills and training to deliver impartialadvice. Reclassification of amedicine from prescription tonon-prescription does not in itself necessarily result inimprovingaccess to that medicine.
6.3 In discussing solutions to the barriers and the issue ofgood governance andaccess to non-prescription medicines, theProject Group looked beyond theregulatory process and analysed theelements of a successful reclassification(switch). The Groupconsidered what would be the favourable considerations forswitchand agreed that these should be based on the characteristicsdiscussed indetail below.
Safety, ease of use and appropriate monitoring forswitchedproducts
6.4 Pharmacovigilance evidence to establish an acceptable safetyprofile for amedicine is pivotal in any reclassification. Noproducts are switched without a fullreview of their safety and adecision that they can safely be used for self-treatmentwithoutmedical intervention. Most safety data are gathered from experienceof useof a medicine in the prescription setting. While thelegislation regarding classification
of medicines is common in Europe, opinions on reclassificationare often divergent,even with medicines for established self-careindications, the presentation andmanagement of which would,arguably, rarely differ between Member States.
6.5 The move to centralised pharmacovigilance monitoring givesMember States theadvantage of easier access to information aboutthe safety in use of medicines thatare already available withoutprescription in other Member States. Thispharmacovigilanceinformation could also help to inform Member States decisionson
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reclassification, alongside the considerations of theirself-medication culture and thecharacteristics of their medicinesdistribution systems.
6.6 Ongoing monitoring of safety of non-prescription medicinesin use is important notonly for those which are newly reclassifiedbut also for well established products.
Appropriate and proportionate action has been taken by theregulators if there is newevidence to demonstrate a change in thesafety or risk profile of a non-prescriptionmedicine, includingevidence 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 ofnon-prescription medicinesis not being picked up by the public orhealth professionals. Research amongpharmacists indicates thatpharmacists perceive the abuse and misuse of some non-prescriptionmedicines, particularly those containing opioids, antihistamines,andlaxatives, to be a problem [Ref 24]. The limited means tocontrol and monitor non-prescription medicine use should be aconsideration when a product is reclassifiedand as part of ongoingsafety 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 supportthe decision for the switch of a productfrom prescription only tonon-prescription.
6.9 Benefit to public health can be demonstrated in differentways. For example, thedevelopment of non-communicable and chronicdisease, such as obesity andsmoking related diseases, is anemerging public health threat. Empowering peopleto changebehaviours and take steps to prevent the development of chronicdisease,such as those related to smoking and obesity, for peoplewho are not yet ill and whoare not visiting the doctor, can besupported by access to appropriate non-prescription medicines.Also, patients already suffering from non-communicable andchronicdiseases should be better empowered through self-care, withassistance andadvice on a regular basis from their doctor andpharmacist where necessary.
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6.10 Self-care is also appropriate for the management ofrecurring conditions thathave already been first diagnosed by adoctor, with on-going health professionalsupport as required.
Responding to the needs and demands of citizens andhealthprofessionals, in particular in terms of patient empowerment,timelyaccess, access to improved treatments and improved quality oflife
6.11 Efficient, rapid and sustainable symptom relief will enableindividuals to carry onwith their daily activities. This isparticularly significant where quick access to a doctoris notalways possible or where delay in treatment can make the conditionworse. Ifsymptoms persist, clear warnings on the label and patientleaflet will encouragepeople to seek advice where there is a needsubsequently to consult the doctor.
6.12 Advances in modern medicine, including in pharmacologicalprofile, longerduration of action or fewer side effects, benefitall medicines takers. Where atherapeutic area or indication forself-care is well established and people areaccustomed to managingthe conditions by themselves, there is benefit in makingbest use ofadvances in modern medicine in the range of non-prescriptionmedicinesavailable.
6.13 It is important that health professionals are supported intheir decision makingwhen responding to symptoms by evidence-basedinformation and resources inrelation to the correct and appropriateuse of non-prescription medicines. This is
particularly important when a medicine is newlyreclassified.
6.14 Post-authorisation studies in the community and primarycare setting may be anideal vehicle for providing ongoing evidenceof use of non-prescription medicines inpractice and should beencouraged in justified cases.
Fulfilling unmet needs
6.15 For a number of reasons individuals sometimes suffer fromconditions withoutconsulting a doctor. This might be because ofconcern about what might be an
unpleasant treatment, because they are embarrassed, because theyconsider thecondition to be too trivial or because they do notthink there is a treatment for theirproblem and they just have toendure it. They may silently suffer from the condition,delaying avisit to the doctor until the situation becomes unbearable; theymay alsoresort to seeking solutions on the internet leavingthemselves vulnerable to accessingunproven treatments andcounterfeit medicines and risking worsening theirconditions.
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6.16 Increasing access to medicines under these circ*mstancescan result in bringingpeople into the healthcare system sooner andprevent damage to health caused by,for example the use ofcounterfeit medicines obtained via the internet.
Health professionals embracing the switch
6.17 Support by health professionals is important to ensureeffective self-care andself-treatment and as a source ofinformation, support and guidance on self-care. Therole of healthprofessionals is also critical to the success of a switchedproduct.
6.18 As people recognise and value the expertise of pharmacistsand doctors thesehealth professionals have an important role toplay in empowering people to take anactive role in theirhealthcare. The public expects that all the healthprofessionalsthey encounter are working for the patients bestinterests and that doctors andpharmacists will collaborate. Theyexpect consistent messages and to be giveninformation that they canunderstand and act upon. The cooperation of doctors andpharmacistsis therefore very important to ensure that patients receiveconsistentinformation about the illness, not just the product andits contraindications, as well asinformation about when it isappropriate to use a non-prescription medicine and whenthey mightneed to see a doctor or other health professional.
6.19 Doctors are often unaware that a medicine has beenreclassified even inMember States where the self-care culture iswell developed. This can inhibit acollaborative approach tosupporting 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 healthbenefit
6.20 The safety of all medicines is a key priority, andassessment of risk in the non-prescription setting is fundamentalto reclassification of a medicine. However, thereare good examplesof the value of improving access to a medicine where it is safetodo so, in terms of public health benefit.
6.21 The benefit-risk model for a non-prescription medicine willvary considerablybetween different medicinal products. There shouldbe consideration of public healthbenefit as part of this model foreach non-prescription medicine.
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All stakeholders have a common approach
6.32 Clear, consistent views and messages about the benefits andrisks of a newlyreclassified medicine will contribute to asuccessful switch by increasing patientconfidence and ensuringresponsible, safe and appropriate use.
Patients have access to information and advice
6.33 Patients need not only to be aware of a newly reclassifiedmedicine but also tohave access to accurate and impartialinformation, which can be distinguished fromadvertising andpromotional material, and health professional advice abouttheproduct and the therapeutic area for which it is indicated. Thisgives patients theconfidence and the skill to take advantage ofavailability of the medicine withoutprescription.
Patients are fully empowered by good education and support fromhealthprofessionals when needed
6.34 Patients who have good basic knowledge and understanding ofhow to look afterthemselves are well placed in general tounderstand where a newly reclassifiedmedicine fits into the area ofself-care and will have the confidence to take advantageof itsaccessibility without the need for a prescription.
Education and involvement of pharmacists and doctors
6.35 Education and involvement of pharmacists and doctors isparticularly importantfor innovative switches when a product with anew self-care indication becomesavailable without prescription, sothat patients receive the support they need fromdoctors andpharmacists to use the product safely and effectively.Meaningfulcontinuing professional education should play asignificant role in this process.
Economic viability
6.36 Economic viability includes an acceptable commercial returnon investment ofthe switch for the manufacturer and an affordableprice for the patient. From thepatient perspective, the price of anon-prescription medicine can interfere with thechoice to buy theproduct. When costs of medication become a barrier to its use,thepotential to support self-care is diminished. Switches shouldideally not lead to healthinequalities or penalise people from lowincome groups.
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7.5 Key themes have emerged which are not part of the regulatoryprocess for legalclassification and which have helped to identifyfactors that will contribute to goodgovernance of non-prescriptionmedicines.
Focus on the benefits of medicines
7.6 While the safety of non-prescription medicines must remain akey priority whenreclassifying a medicine from prescription only tonon-prescription, it is also importantthat the benefits, as well asthe risks of non-prescription medicines are considered.The addedvalue of the use of a medicine without prescription, both forindividualsand for public health, should support a decision for thereclassification of a productfrom prescription only tonon-prescription status. An understanding of the benefits aswell asthe risks by health professionals and patients is also important sothat theycan make informed choices about recommending and usingnon-prescription
medicines respectively. Examples of switches that haveparticularly demonstratedpublic health benefits are nicotinereplacement therapy and emergency hormonalcontraception.
Safety, ease of use and appropriate monitoring forswitchedproducts
7.7 Safety is a priority and a focus for all stakeholders and itis important that thesafety concerns of all stakeholders aremet.
7.8 The EMA has already recognised the need for the developmentof tools to ensurea balanced benefit-risk assessment allowingdifferent assessors and differentcompetent authorities to sharebenefit-risk analyses, which is an important step infurtherencouraging an information and data-sharing culture amongnationalregulators. This concept should be taken further byenabling the exchange ofinformation and experiences between thosein competent authorities who areinvolved in the assessment ofreclassification applications and encouraging thesharing ofassessment reports.
7.9 It is also important to monitor how medicines are used inreal life.
Pharmacovigilance monitoring gives Member States access toinformation about thesafety in use of medicines that are alreadyavailable without prescription in otherMember States, to assurethemselves that national switches elsewhere have not ledto anincrease in adverse reactions. In some respects, real life use ofmedicines thathave been reclassified in some Member States can beregarded as pilots for otherMember States considering reclassifyingthat medicine. The EU pharmacovigilancelegislation provides theopportunity to enhance the monitoring of non-prescription
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medicines through patient reporting of suspected adversereactions, greateropportunities for post authorisation safety andefficacy studies and risk managementplans to be put in place. Postauthorisation studies in primary care could help gaininsight intothe use in practice of non-prescription medicines.
Attitudes of stakeholders
7.10 The attitudes of stakeholders are a key factor in access tonon-prescriptionmedicines. Among those countries surveyed, moststakeholders have a positiveattitude to non-prescription medicinesand reclassification. There is wide recognitionamong allstakeholders that reclassification of medicines is a benefit topublic healthas it:
enables quicker access to treatments, with no waiting times indoctorssurgeries
allows more therapeutic choice, particularly for minorailments
frees up doctors time and
saves public health funds.
7.11 Safety is a key concern identified, particularly byregulators but also by healthprofessionals and by consumerrepresentatives.
7.12 Patients expect pharmacists to support them in theirdecisions to choose anduse non-prescription medicines and inrecognising when medical advice should besought, and they expectconsistent advice from healthcare professionals. Differentattitudesand advice, particularly from pharmacists and doctors aboutself-medicationand use of non-prescription medicines can causeconfusion and reduce publicconfidence in self-medication. Supportfrom all health professionals is a key successfactor for areclassification.
7.13 To facilitate a supportive attitude and common approach tonon-prescriptionmedicines, the needs and concerns of allstakeholders must be met. Involvingpharmacists and doctors early inthe process before switches take place would givethem theopportunity to raise those concerns and for those concerns to beaddressedin a scientific and evidence-based way. Doctors mainconcerns are based onpossible risks of serious underlyingconditions being missed. However, use of non-prescription medicinesdoes not mean exclusion of the doctor in care pathways andthedevelopment of collaborative care models between patients,pharmacists anddoctors will help identify and address safetyconcerns.
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7.14 Consulting with health professionals before areclassification can also generateawareness of the switch underconsideration and allows them to identify whatinformation orsupport materials may be needed to enable them to support patientsin
the safe and effective use of the medicine.
7.15 There are good examples of collaborative care programmeswith the support ofmedical professionals and pharmacists focusingon 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 animportant enabler forcollaborative care programmes and insupporting patients in general in their choice
and use of non-prescription medicines.
7.17 While in all Member States, pharmacists education andtraining equips themwith the required clinical and therapeuticknowledge, the pharmacy professionrecognises that effectivecommunication and counselling should be an integral part ofpharmacyeducation in all Member States in order to meet patientsexpectations.
7.18 Self-care training programmes for doctors were available inonly two of twentycountries surveyed. While the medical professionconsidered that education for self-care for minor ailments wasalready covered in the ordinary undergraduate and
specialist training programmes for doctors, doctorrepresentatives in 9 countriesconsidered that a self-care trainingprogramme would be of benefit and 9 agreed thatit would relievedoctors workload.
7.19 Education of patients in self-care is also important. Allstakeholders recognisethe importance of patient empowerment througheducation to ensure that people areable to decide when toself-treat and when to seek advice from a pharmacist or fromadoctor when the condition is more serious. Education of patients insafe andresponsible self-care should be regarded as a life skillwhose development should
start early. Basic education in schools will prepare the nextgeneration for the future.Availability of high quality impartialinformation in a variety of forms will help tocontinue to developan individuals knowledge of self-care. However, education andtheavailability of information is only a supplement to the informationand support thatpatients expect to receive from healthprofessionals.
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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 ofthe availability of a medicine withoutprescription. There isbenefit in advertising regulators in Europe sharing information
about how advertising is regulated nationally.
7.21 It is recognised that advertising plays a role inincreasing awareness amongstakeholders of the availability of anon-prescription medicine but it is important thatadvertising doesnot lead to confusion and that patients are able todistinguishbetween advertising and information.
7.22 Delivering information to patients is an integral part ofhealth literacy and acornerstone for better health outcomes.Conversely, lack of information aboutproducts and self-care ingeneral, and about illnesses that can be treated withself-medication, is a barrier to access to non-prescriptionmedicines. All stakeholdershave a role to play in providinginformation to patients to support informed use andthe correctchoice of non-prescription medicines andpeople need to beencouragedto use trustworthy sources of information.
7.23 Regulation requires manufacturers to provide accurate, highquality, user testedpatient information leaflets in the packs ofauthorised medicines. National CompetentAuthorities are required,through the EU pharmacovigilance legislation, to increasetheaccessibility of regulated patient information i.e. SmPCs andPatient Leaflets, by
publishing them on their web-sites.
7.24 The Project Group has identified a number of examples ofbest practice wheregovernments, regulators and health professionalsprovide empowering information topatients and consumers, throughself-care initiatives and programmes, and throughdedicatedhealthcare websites. However, as recognised by EUadvertisingregulators, such initiatives require considerableresources, which are not available inall Member States. However,the development of the social media (Twitter andFacebook) providesthe opportunity for national regulatory agencies to communicatewiththe public through an increasingly familiar medium and in a costeffective way, to
provide information about public health and medicines, and towarn against incorrectinformation.
7.25 Health professionals also have an important role to provideface-to-face andwritten advice, which is greatly appreciated bypatients and consumers. It isimportant that health professionalscan access accurate and impartial informationabout non-prescriptionmedicines 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 andconsiderable effortsinvested in reclassification and in supportingthe introduction into the market of a newreclassification inrelation to the limit of a 12 month data exclusivity period in theEU.
As reclassifications are increasingly complex with the need forextensive educationaland risk management programmes it may benecessary to consider whether furtherincentives are needed toencourage manufacturers to undertake expensive switchprogrammes. Inthe United States and Japan a period of data exclusivity ofthreeyears for a reclassification is provided to incentiviseresearch on self-care.
7.27 The commercial risk borne by manufacturers from innovativereclassification isdemonstrated in case studies undertaken forpantoprazole, omeprazole andsimvastatin which found that, whiletotal sales of all presentations of these active
ingredients experienced increases following theirreclassification, there was no majorgrowth in sales of the productthat was actually switched.
7.28 The low uptake of reclassified products suggests a limitedexploitation of thepublic health benefits of reclassificationexcept for those cases of non-prescriptionavailability of genericversions. If reclassification becomes an unacceptablecommercialrisk this could inhibit access to non-prescription medicines in thefuture.
Pricing and Reimbursem*nt
7.29 Since national healthcare systems and reimbursem*ntarrangements are anational competence, pricing and reimbursem*ntpolicies related to non-prescriptionmedicines vary across the EU.However, improved access could be achieved if allstakeholders had abetter understanding of the reclassification process and therangeand nature of medicines available as non-prescription. It isimportant that it isunderstood that decisions to classify medicinesas non-prescription are based onscientific evidence that they canbe used safely without medical supervision and thatthere is nochange in evidence of efficacy. Therefore, where reclassificationto non-prescription results in that medicine no longer beingreimbursed by the healthcaresystem there is no reason why doctorscould not suggest the purchase of a non-
prescription medicine if that is the most appropriate treatmentconsidering thepatients individual circ*mstances. This could beaddressed through patientinformation and education, and with thesupport of health professionals. In 2004 theintroduction of thegreen prescription form in Germany following the de-reimbursem*ntof non-prescription medicines allowed medical doctors tocontinueprescribing (for patients to purchase) non-prescriptionmedicines that were no longer
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covered by the health insurance funds, signalling to patientsthat these were stilleffective and safe products.
7.30 Acknowledging the economic and public health benefits ofself-medication, othercountries implemented measures thatincentivise citizens to practise responsible self-
care. These may include tax deductions for out-of-pocketpurchases 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 ofnon-prescription medicines.For example, it may be a disincentivefor people to purchase a non-prescriptionmedicine if it was cheaperto visit a doctor and obtain it on prescription. The inabilitytoafford non-prescription medicines can create inequalities betweenthe rich and thepoor regarding the right to practise self-care. Theabsence of pricing controls for non-
prescription medicines in Member States may play a role inreducing theseinequalities. In examining the pricing ofnon-reimbursed, non-prescription medicinesin 2007, the EUCommission and the EU Pharmaceutical Forum have alreadyadvised thatMember States should abstain from price control for theseproducts.
8. Recommendations
Elements of a successful switch
1. Recognising that there are many factors that affect access tonon-prescriptionmedicines, Member States evaluating areclassification should consider thefive elements of a successfulswitch:
a. Safety, ease of use and appropriate monitoring for switchedproducts
b. A clear beneficial impact on public health
c. Responding to the needs/demands of citizens and healthprofessionals, inparticular, in terms of patient empowerment,timely access, access to
improved treatments and improved quality of lifed. Fulfillingunmet 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 inPrimary Care. 20022.WHO Guidelines for the regulatory assessment ofmedicinal products for Self Medication Copenhagen 1980s]3.PGEUsurvey on common pharmacist activities, 2011. ref. Joint FIP/WHOguidelines on goodpharmacy practice standards for quality ofpharmacy services]4.Vogler et al.,OTC medicines: Switches of activeingredients in Europe in the last decade. EMINeT,20125.Vogler etal.,OTC medicines Distribution
6.Vogler et al., OTC medicines Framework of pricing andreimbursem*nt, EMINeT, 20127.Figures based on information providedby AESGP membership,www.aesgp.eu/facts-figures/market-data/8.Development of aninformation policy for medicinalproducts,http://www.aesgp.eu/media/cms_page_media/68/FinalReport%20information%20policy.pdf,2002.]9.Applicable marketing authorisation procedures:CentralisedprocedureThis procedure results in a single marketing authorisationthat is valid in all European Union countries,as well as inIceland, Liechtenstein and Norway. The European Medicines Agencyisresponsible for
the centralised procedure and applications through thecentralised procedure are submitted directly totheAgency.Evaluation by the Agency's scientific committees takes up to210 days, at the end of which thecommittee adopts an opinion onwhether the medicine should be marketed or not. This opinion isthentransmitted to the European Commission, which has the ultimateauthority for granting marketingauthorisations in the EU.Once amarketing authorisation has been granted, themarketing-authorisation holder can begin tomake the medicineavailable to patients and healthcare professionals in all EUcountries.National proceduresMember States have national proceduresfor the authorisation of medicines within their territory.Thesefall outside the scope of the centralisedprocedure.Decentralised procedure (DCP)Companies can apply for thesimultaneous authorisation in more than one EU country of amedicine
that has not yet been authorised in any EU country and that donot fall within the mandatory scope ofthe centralisedprocedure;Mutual-recognition procedure (MRP)Companies that have amedicine authorised in one EU Member State can apply for thisauthorisationto be recognised in other EU countries.10.SmartRegulationhttp://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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