Department of Biological Standardisation, European Network of Official Medicines Control Laboratories (OMCL) & HealthCare (DBO) EXPERT WORKSHOP

Transcription

1 Department of Biological Standardisation, European Network of Official Medicines Control Laboratories (OMCL) & HealthCare (DBO) EXPERT WORKSHOP GOOD PRACTICES FOR THE CLASSIFICATION OF MEDICINES AS REGARDS THEIR SUPPLY WHICH PROTECT PUBLIC HEALTH AND PROMOTE THE ACCESSIBILITY OF MEDICINES IN EUROPE PROCEEDINGS 8-9 (noon) November 2011 European Directorate for the Quality of Medicines & HealthCare (EDQM) Council of Europe Venue: Palais de l Europe, avenue de l Europe

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3 TABLE OF CONTENTS Pages I - PROGRAMME... 6 II WELCOME ADDRESS Ms Viola MACOLIĆ-ŠARINIĆ Activities and role Committee of Experts CD-P-PH/PHO III KEY NOTE SPEECH Ms Zaïda FRIAS Switching in the Centralised Procedure IV PRESENTATIONS Session theme: The classification of medicines as regards their supply from the perspectives of patients, healthcare professionals and industry Ms Jolanta BILIŃSKA The classification of medicines: the patients perspective Dr Luc BESANÇON Pharmacists views on the classification of medicines as regards their supply Dr Ivana STAREŠINIĆ-ŠERNHORST Pharmaceutical industry s view: association of European self-medication industry - AESGP Session theme: A response at Council of Europe level: Mandate, approach, results, impact of the working programme of the Committee of Experts CD-P-PH/PHO Mr Markus PONGRATZ Council of Europe Committee of Ministers Resolution ResAP (2007)1, Dr Dina LOPES The implications of new modes of medicines supply on classification practice improving patient safety and the quality of the delivered medicine Session theme: Societal, Regulatory, Scientific dimensions of the classification of medicines for supply in Europe Dr Bruno DE SCHUITENEER Scientific dimension Ms Maja SLANINKA Risks and benefits of OTC drugs Ms Amanda WILLIAMS Legal Classification Choices and Decisions Dr Simona BADOI

4 Regulatory dimension of the classification of medicinal products in Europe for supply Session theme: Learning about and understanding the differences, needs and expectations of different national healthcare systems and other stakeholders of medicines classification as regards their supply Mag. Thomas BURKHARD The Austrian Health Care System Dr Anna CIEŚLIK Challenges, opportunities and solutions: national differences in medicines classification and supply status. 65 V - BREAK-OUT SESSIONS Break out session The classification of medicines in Council of Europe member states and its impact on public health: needs from the perspectives of patients, health professionals and industry expectations as regards support by national authorities and the EDQM (Council of Europe) and its Committee of Experts CD-P-PH/PHO Breakout session Good classification practices the contribution of the Committee of Experts CD-P-PH/PHO VI - EXPERT WORKSHOP CONCLUSIONS Introduction How to harmonise the application of relevant EU legislation in the different member states? How to harmonise standards for the classification of certain therapeutic classes? How best to meet patients needs and expectations of quality of life? Should DRAs have a reactive or proactive approach to switching to OTC medicines? New trends as regards the modes of supply of medicines and their impact on good classification practices Added value provided by the Committee of Experts CD-P-PH/PHO for patients, national, international and European health and drug regulatory authorities, and industry VII - SPEAKERS VIII - ORGANISING COMMITTEE IX - SPEAKERS CURRICULA VITAE X - LIST OF PARTICIPANTS XI - APPENDICES Appendix 1: European Union and national legislation

5 Appendix 2: Council Of Europe Committee Of Experts On The Classification Of Medicines As Regards Their Supply (CD-P-PH/PHO) Appendix 3: Press statement Appendix 4: Implementing the European Medicines Agency s road map to 2015: The Agency s contribution to Science, Medicines, and Health

6 I - PROGRAMME Background and objectives The availability of medicines with or without a medical prescription has implications for patient safety, the accessibility of medicines for patients and the responsible management of health care expenditure. The decision on prescription status and related supply conditions is a core competency of national health authorities. The conditions of the supply of medicines vary considerably due to the facts that the provisions are interpreted and implemented differently by the member states of the Council of Europe and that important additional classification criteria are not harmonised. In the light of moves to make medicines more available without a prescription, the harmonisation of classification criteria and supply conditions including package sites and age limits are relevant for public health protection. The working programme of the Committee of Experts on the Classification of Medicines as regards their Supply (CD-P-PH/PHO) implements Committee of Ministers Resolution ResAP(2007)1 on the classification of medicines as regards their supply 1. The Committee of Experts CD-P-PH/PHO issues annually recommendations to health authorities of member states, EU and non EU members, for the classification of medicines as regards their supply and establishes good classification practices 2. In its work, the Committee of Experts CD-P-PH/PHO focuses on public health promotion and uses scientific approaches, taking account of the national assessments of direct and indirect risks which may occur under normal treatment conditions and under medical surveillance as well as from foreseeable mis- or abuse of medicines. The recommendations are also useful for pharmaceutical manufacturers and commercial operators of mailorder trade in medicines, where such trade is legal. Pioneers in this field, the Council of Europe bodies have been concerned as from 1961 with issues relating to the classification of medicines into prescription and non-prescription medicines. The classification criteria set out in Council of Europe resolutions in this field were taken over by the Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use and by the Directive 2001/83/EC (Art 70-75) of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. In the preamble of later directive (item 32) reference is made to the Council of Europe: «it is therefore appropriate to harmonise the basic principles applicable to the supply of medicinal products in the Community of member state concerned, while taking as a starting point the principles already established on this subject by the Council of Europe». - The current European directives which are based on the above mentioned directives foresee only two obligatory classification categories (prescription and non-prescription status, important additional classification criteria as applied by the Council of Europe resolutions in this field are not included. - There are no other taxative lists available on the conditions of use associated to the classification into prescription or non-prescription medicines. 1 BackColorIntranet=EDB021&BackColorLogged=F5D

7 - The classification status of medicines authorised in Europe via the national and mutual recognition procedures remains a national competency of the member states. This was confirmed in the Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use The Committee of Experts CD-P-PH/PHO supervises a database, hosted by the EDQM 3 which stores national information about the classification and supply conditions of medicines as well as the annually revised appendices to Council of Europe Resolution ResAP(2007)1. The information is publicly available. Other European institutions such as the European Medicines Agency (EMA), the Deutsche Institut für Medizinische Daten und Information (DIMDI), and the WHO Centre for Drug Statistics Methodology provide information about the classification and supply status of medicines authorised in the EU via the centralised, decentralised and mutual recognition procedures for marketing authorisation. Recommendations about the classification of 2400 medicines are published in the database. Providing a platform for dialogue and consensus-building on the supply conditions of medicines in Europe, the Committee of Experts CD-P-PH/PHO promotes patient safety and where appropriate access to medicines without a prescription across Europe: This helps foster public health and manages responsibly healthcare resources. Aim of the expert workshop The workshop is aimed at: - Confirmation of the specific support and value of the Committee of Experts CD-P-PH/PHO for the stakeholders, the direction and focus of its work and agreement on initiatives targeted to help promote the accessibility of medicines in Europe whilst protecting public health; This will include: promotion of the use and implementation of the results of the working programme of the Committee of Experts CD-P-PH/PHO and strengthening its role and function in the European context; learning about and understanding the differences, needs and expectations ( feed-back ) of different national healthcare systems and other stakeholders of medicines classification as regards their supply; providing a multisectorial and multidisciplinary platform for the discussion of the societal, scientific, and regulatory dimension of the classification of medicines as regards their supply; identifying key elements of good medicines classification practices taking into account the above mentioned dimension. Target audience officials from drug regulatory authorities (DRA) from Council of Europe member states, observer states to the meetings of the European Pharmacopoeia Commission, Chairpersons and members of National Drug Committees, National sick funds; representatives from European institutions and international organisations, such as the WHO, Regional Office for Europe, and the European Commission, its subordinate agencies, the European Medicines Agency (EMA) and its bodies such as the Committee for Medicinal Products for Human Use (CHMP). 3 Database on the classification of medicines as regards their supply (Melclass) Appendices (2010), Committee of Ministers Resolution ResAP(2007)1 Password: melclasscoe2005 User are encouraged to send specific comments and information via the mailbox :melclass@edqm.eu 7

8 As the training will be held in English, participants need to be fluent in that language. Speakers The speakers list is appended to the programme. Working methods The first conference day will be open to officials from public administrations, experts/scientists from academic institutions, speakers from patients, healthcare professionals associations, such as doctors and pharmacists, industry associations to present views on their associations roles and needs as regards the classification of medicines as regards their supply and what is expected from the working programme of the Committee of Experts on the Classification of Medicines as regards their Supply (CD-P-PH/PHO). It will be a forum for presentations about the existing situation as regards medicines classification and supply conditions, national differences and the discussion of key elements of good practices of the classification of medicines. The second conference day will be devoted to authorities officials, representatives of international organsations and European institutions summaries and conclusions on the presentations of the first day. In moderated break-out sessions, the officials will develop key elements of good classification practices and the specific contribution of the Committee of Experts CD-P-PH/PHO to their practical, effective and verifiable implementation. In the focus of the discussions will be the benefit of patients quality of life and the responsible management of healthcare budgets. Organisation **** Registration 7 November p.m. 8 November a.m. Council of Europe, Palais de l Europe, avenue de l Europe 4 Conference Registration Desk Plenary sessions (PS) Palais de l Europe Room 2 Break-out sessions (BS) Palais de l Europe Rooms 2, 3, 6 Coffee break Cafeteria (Palais de l Europe) - Bar des 12 Etoiles Lunch Restaurant (Palais de l Europe) Workshop materials Press statement will be made available to the participants in a Conference bag at registration 9 November 2011, p.m., venue to be confirmed Accommodation Rooms have been pre-booked at the Inter-Hotel Strasbourg LE FORUM [5]. All participants are asked to book their hotel rooms at the latest by 15 October Inter-Hotel Strasbourg LE FORUM, 50, Rue de Bischwiller, F Strasbourg (Schiltigheim), Tel.: / Fax: contact@hotel-forum-strasbourg.com; 8

9 Tuesday, 8 November 2011 Welcome address and opening Plenary session (PS) Room: a.m. Ms Susanne KEITEL, Director, European Directorate for the Quality of Medicines & HealthCare (EDQM) (Council of Europe) 9.10 a.m. Ms Viola MACOLIĆ-ŠARINIĆ, Agency for Medicinal Products and Medical Devices of Croatia, Chair Committee of Experts on the Classification of Medicines as regards their Supply (CD-P-PH/PHO): Activities & role - Committee of Experts CD-P-PH/PHO Key note speeches 9.20 a.m. Ms Zaïda FRIAS, European Medicines Agency (EMA) 9.40 a.m. Discussion Session theme: THE CLASSIFICATION OF MEDICINES AS REGARDS THEIR SUPPLY FROM THE PERSPECTIVES OF PATIENTS, HEALTHCARE PROFESSIONALS AND INDUSTRY Session Chairperson: Ms Colette McCREEDY, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom 9.50 a.m. Patients views Ms Jolanta BILIŃSKA, International Alliance of Patients Organizations (IAPO) a.m. Healthcare professionals views: Doctors Ms Viola MACOLIĆ-ŠARINIĆ, Agency for Medical Products and Medical Devices, Croatia and Ms Irena MEISSNER-WANTUCH, Ministry of Health, Poland a.m. Healthcare professionals views: Pharmacists Dr Luc BESANÇON, Manager, Scientific and Professional Affaires, International Pharmaceutical Federation (FIP) a.m. Pharmaceutical industry s views Ms Ivana STAREŠINIĆ-ŠERNHORST, European Self-Medication Industry (AESGP) a.m. Coffee break Session theme: A response on Council of Europe level : Mandate, approach, results, impact of the working programme of the Committee of Experts CD-P-PH/PHO Session Chairperson: Ms Viola MACOLIĆ-ŠARINIĆ a.m. Council of Europe Committee of Ministers Resolution Res AP (2007)1 and annually revised appendices: working methods, impact Information exchange: Database on the Mr Markus PONGRATZ, Vice- Chairman, Committee of Experts CD-P- CD-P-PH/PHO 9

10 legal classification of medicines for supply ( Melclass ) Scientific classification reports Cont.: Tuesday, 8 November a.m. Policy snapshots: impact of new modes of medicines supply on good medicines classification practices Plenary session (PS) Room: 3 Ms Dina LOPES, National Institute for Medicines and Healthcare products (INFARMED), Portugal noon Discussion Session theme: SOCIETAL, REGULATORY, SCIENTIFIC DIMENSIONS OF THE CLASSIFICATION OF MEDICINES FOR SUPPLY IN EUROPE Session Chairperson: Ms Merjem HADJIHAMZA, Ministry of Health, Former Yugoslav Republic of Macedonia (FYROM) noon Scientific dimension Dr Bruno DE SCHUITENEER, Belgian Federal Agency for Medicines and Health Products and Ms Maja SLANINKA, PHD, University of Skopje, Former Yugoslav Republic of Macedonia (FYROM) p.m. Lunch 1.30 p.m. Societal dimension Ms Viola MACOLIĆ-ŠARINIĆ, Agency for Medical Products and Medical Devices, Croatia and Ms Irena MEISSNER- WANTUCH, Ministry of Health, Poland 2.00 noon Regulatory dimension Ms Amanda WILLIAMS, Medicines and Healthcare products Regulatory Agency, (MHRA), United Kingdom, and Ms Simona BADOI, National Agency for Medicines, Romania 2.30 p.m. Discussion Session theme: Learning about and understanding the differences, needs and expectations of different national healthcare systems and other stakeholders of medicines classification as regards their supply Session Chairperson: Mr Mike MORRIS, Irish Medicines Board 3.00 p.m. Challenges, opportunities and solutions: national differences in medicines classification and supply status Mr Thomas BURKHARDT, Main Association Social Security Institutions, Austria and Dr Anna CIEŚLIK, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Poland p.m. Coffee break 10

11 II WELCOME ADDRESS 11

12 Ms Viola MACOLIĆ-ŠARINIĆ Activities and role Committee of Experts CD-P-PH/PHO 12

13 Ms Viola MACOLIĆ-ŠARINIĆ Activities and role Committee of Experts CD-P-PH/PHO 13

14 III KEY NOTE SPEECH 14

15 Ms Zaïda FRIAS Switching in the Centralised Procedure 1. The legal status of a product at EU level has historically been a Member state prerogative whether obtained through a purely national, Mutual Recognition or Decentralised authorisation Procedures, thereby making the Centralized procedure operated at the European Medicines Agency (EMA) the first and only authorisation route in the EU which results in a truly harmonised legal status. 2. In 2005, with the major revision of the Pharmaceutical legislation a provision was specifically introduced to allow non-prescription products the possibility of accessing the Centralised procedure under the optional scope that is if their authorisation constitutes either significant therapeutic, scientific or technical innovation or that the granting of authorisation is in the interest of patients at Community level. 3. For the latter, the CHMP defined early on a set of criteria favouring those switches with an inherent scientific challenge, e.g. first in class switches (e.g. Xenical/alli- orlistat, Viagra-sildenafil), products already switched in a few Member States (Pantoloc control- pantoprazole, sumatriptan) and those where divergent outcomes exist at EU level but they are not eager to engaging in the assessment of nonprescription medicines already widely available at the national level (e.g. paracetamol, ibuprofen or even nicotine replacement therapies). 4. The experience of switches through the Centralised procedure is limited to 5 applications resulting so far in 2 approvals (alli, pantoloc control), 2 withdrawals (Viagra, ibuprofen/diphenhydramine combination) and 1 ongoing application for sumatriptan which is currently under re-examination following a negative CHMP opinion. 5. It is however to be emphasised that the future of innovative non-prescription medicines lies solely within the Centralised procedure, given that the vast majority of New active substances are authorised through the Centralised procedure and future switches to non-prescription of those have no choice but to come centrally. 15

16 6. There is therefore a clear benefit in working collectively in order to make a harmonised legal status for non-prescription status happen at EU level and international comparisons and evaluations such as the ones performed by the EDQM expert group potentially an important asset in facilitating these switches. 7. Such discussion is however not purely a scientific one of balancing benefits and risks following quality, safety and efficacy assessment but is widely influenced by other external factors such as: national differences existing with regards to the healthcare systems or the supply of the medicinal products (pharmacy only versus general sale) the differences in consumer and healthcare professional attitudes towards self medication across the EU; but also differences in use of appropriate tools available to ensure safe and effective use (e.g. product information, naming and pack design, educational materials versus promotion and advertisement) 8. Main challenges for the harmonisation at EU level will be to reflect on opportunities for improvement within the current legal/regulatory framework which is based on a bilateral process between regulatory authority and company; and to re-engineer it to also foresee a consultative process involving pharmacists, doctors, consumers/patients and other expert groups such as the EDQM. This would allow for the widening of the debate and effectively take on board other benefits of nonprescription products such as empowerment of patients, ease of access, reduced absences level, more efficient use/consultation of doctors and pharmacists,... all of which are currently not easily considered in the debate at centralised level. 9. And given that a switch is inherently a safety driven discussion, seriously consider the involvement of the new Pharmacovigilance Committee introduced by the recent revision of the Pharmacovigilance legislation and potentially a key player in considering switches at a global level. 10.All in all the EMA/CHMP needs to broaden its experience in the area of non-prescription through the review of more MA applications; possibly engage in exchanging information with the EDQM expert group which has a longstanding experience in the matter; and seriously consider the introduction of supportive decision making models on the B/R evaluation specifically designed to take into account the particularities of non-prescription products mentioned earlier. 11.To date, the EMA activities on non-prescription medicines included the set up of the so-called EMA/AESGP platform with the self-medication industry association, which have been organised since 2007 to facilitate a constructive dialogue on non-prescription medicines and to deal specifically with any potential hurdles in the access to the Centralised procedure. Many issues have been addressed and resolved through such dialogue and will continue as it has generally proven of benefit. 12.That does not preclude that there is certainly scope to complement these activities further through: carrying out reviews on the classification practice in various therapeutic areas identified as candidates for OTC, and exploring the underlying rationale for benefits of switch compared to concerns raised in terms of public health which seem to constitute a common objective for which a collaboration could be of mutual benefit going forward. 13. Moreover, since the topic of optimizing the access of non-prescription medicines to the Centralised procedure has been actually identified as a topic of high priority in the CHMP Work programme even the timing for engaging in a dialogue and collaboration is quite right. 16

17 The exact details and modalities of such collaboration between the CHMP and the EDQM would of course need to be further elaborated on but would have the valuable aim at further promoting harmonisation and equal patient access to non-prescription medicines across Europe and beyond. 17

18 IV PRESENTATIONS 18

19 Session Chair: Ms Colette McCREEDY Medicines and Healthcare products Regulatory Agency (MHRA) United Kingdom Session theme: The classification of medicines as regards their supply from the perspectives of patients, healthcare professionals and industry Speakers: Ms Jolanta BILINSKA International Alliance of Patients Organisations (IAPO) Dr Luc BESANÇON Manager, Scientific and Professional Affaires International Pharmaceutical Federation (FIP) Dr Ivana STAREŠINIĆ-ŠERNHORST European Self-medication Industry (AESGP) 19

20 Ms Jolanta BILIŃSKA The classification of medicines: the patients perspective 20

21 Ms Jolanta BILIŃSKA The classification of medicines: the patients perspective 21

22 Ms Jolanta BILIŃSKA The classification of medicines: the patients perspective 22

23 Ms Jolanta BILIŃSKA The classification of medicines: the patients perspective 23

24 Dr Luc BESANÇON Pharmacists views on the classification of medicines as regards their supply 24

25 Dr Luc BESANÇON Pharmacists views on the classification of medicines as regards their supply 25

26 Dr Ivana STAREŠINIĆ-ŠERNHORST Pharmaceutical industry s view: association of European self-medication industry - AESGP 26

27 Dr Ivana STAREŠINIĆ-ŠERNHORST Pharmaceutical industry s view: association of European self-medication industry - AESGP 27

28 Dr Ivana STAREŠINIĆ-ŠERNHORST Pharmaceutical industry s view: association of European self-medication industry - AESGP 28

29 Dr Ivana STAREŠINIĆ-ŠERNHORST Pharmaceutical industry s view: association of European self-medication industry - AESGP 29

30 Dr Ivana STAREŠINIĆ-ŠERNHORST Pharmaceutical industry s view: association of European self-medication industry - AESGP 30

31 Dr Ivana STAREŠINIĆ-ŠERNHORST Pharmaceutical industry s view: association of European self-medication industry - AESGP 31

32 Session theme: A response at Council of Europe level: Mandate, approach, results, impact of the working programme of the Committee of Experts CD-P-PH/PHO 32

33 Session Chair: Ms Viola MACOLIĆ-ŠARINIĆ Agency for Medicinal Products and Medical Devices of Croatia Speakers: Mr Markus PONGRATZ Vice-Chairman, Committee of Experts CD-P-PH/PHO Dr Dina LOPES National Institute for Medicines and Healthcare products (INFARMED), Portugal 33

34 Mr Markus PONGRATZ Council of Europe Committee of Ministers Resolution ResAP (2007)1, Information exchange and Scientific classification reports 34

35 Mr Markus PONGRATZ Council of Europe Committee of Ministers Resolution ResAP (2007)1, Information exchange and Scientific classification reports 35

36 Mr Markus PONGRATZ Council of Europe Committee of Ministers Resolution ResAP (2007)1, Information exchange and Scientific classification reports 36

37 Mr Markus PONGRATZ Council of Europe Committee of Ministers Resolution ResAP (2007)1, Information exchange and Scientific classification reports 37

38 Dr Dina LOPES The implications of new modes of medicines supply on classification practice improving patient safety and the quality of the delivered medicine Committee of experts on the classification of medicines as regards their supply (CD-P-PH/PHO) Survey Implications of electronic prescribing and new modes of medicines supply such as e- pharmacies, via non-pharmacy-outlets on the classification practices into prescription and nonprescription medicines Report One of the main concerns of the CD-P-PH/PHO is that the result of its activities is adequate to the reality in the different countries. Given the increasing diversity in channels of supply of medicines, the Committee often discussed if its criteria for classification were adequate to this new reality. Also, it felt the need to understand if this new channels or modes of supply were changing the way in which the various countries attributed classification for supply to the medicines. For this reason, the Committee decided to conduct a survey with the objective to know the reality in the different countries, and understand if the new modes of supply of medicines to the public were having an impact on how the classification is attributed. The result is a photograph, a snapshot of practices in a given moment in time. The Committee will maintain it updated and will suplement it with further data if considered useful. Information was received from 19 countries: Croatia, Hungary, United Kingdom, Norway, Portugal, Poland, Czech Republic, France, Republic of Macedonia, Belgium, Austria, Spain, Sweden, Greece, Romania, Netherlands,Finland, Ireland and Bosnia and Herzegovina. The Committee stresses that differences between the various countries have to be understood in the light of the different national health systems and policies. Data: 1 st part - Supply to the patient In about 58% of the countries (11/19) medicines can be sold in non-pharmacy outlets and the presence of a pharmacist is mandatory only in 1 of these countries. Specific training of staff is mandatory in 1 country. In 1/3 of the countries with non-pharmacy outlets access to information on ADRs (Adverse Drug Reaction) is the same as for pharmacies. None of the countries made any changes to their criteria of classification for supply. And the classification for supply is a criteria when deciding which medicines can be sold in non-pharmacy outlets. 38

39 With the exception of only 2 countries, characteristics such as maximum pack size and pharmaceutical form are taken into consideration when deciding on the medicines that can be sold outside the community pharmacy. 2 nd part - Internet Pharmacies (e-pharmacies) Legal internet pharmacies exist in 11 of the 19 countries (about 58%).In half of these countries there are lists of medicines that these pharmacies can sell. In the other half there is no difference from physical pharmacies. There are no restrictions for eg regarding maximum pack sizes or strengths of the medicines. Dispensing by internet pharmacies is not considered during the process of classification. In 4 countries there is a certification procedure in place, and in 2 countries there are specific provisions for inspection of the way this pharmacies work. In all countries the internet pharmacies are linked to a physical pharmacy, having therefore access to the same level of information in all aspects of the use of medicines. Although in many countries there is a specific obligation to provide information on the medicines to the patient, all countries expect that the same level of information provided in physical pharmacies is also provided by internet pharmacies. Regarding internet pharmacies, we can conclude that their introduction has had no impact on classification practices, mainly because they are linked to community services, and therefore the level of service provided is expected to be the same. 3 rd part Electronic prescription Electronic prescription exists in 9 countries (47%) and safety transmission o f data issues have been addressed in all of them. There are split practices in relation to directing the patient (or not) to a specific pharmacy. Electronic prescription does not affect the possibility for the patient to ask for substitution of a brand medicine for a generic. In conclusion, we can see a trend to implement this form of prescription in an increasing number of countries, but so far with no impact on classification practices October

40 Session theme: Societal, Regulatory, Scientific dimensions of the classification of medicines for supply in Europe 40

41 Session Chair: Ms Merjem HADJIHAMZA Ministry of Health Speakers: Dr Bruno DE SCUITENEER Belgian Federal Agency for Medicines and Health Products Ms Maja SLANINKA PHD, University of Skopje Ms Amanda WILLIAMS Medicines and Healthcare Products Regulatory Agency (MHRA) Dr Simona BADOI National Agency for Medicines 41

42 Dr Bruno DE SCHUITENEER Scientific dimension 42

43 Dr Bruno DE SCHUITENEER Scientific dimension 43

44 Dr Bruno DE SCHUITENEER Scientific dimension 44

45 Dr Bruno DE SCHUITENEER Scientific dimension 45

46 Dr Bruno DE SCHUITENEER Scientific dimension 46

47 Dr Bruno DE SCHUITENEER Scientific dimension 47

48 Dr Bruno DE SCHUITENEER Scientific dimension 48

49 Dr Bruno DE SCHUITENEER Scientific dimension 49

50 Dr Bruno DE SCHUITENEER Scientific dimension 50

51 Dr Bruno DE SCHUITENEER Scientific dimension 51

52 Dr Bruno DE SCHUITENEER Scientific dimension 52

53 Ms Maja SLANINKA Risks and benefits of OTC drugs 53

54 Ms Maja SLANINKA Risks and benefits of OTC drugs 54

55 Ms Amanda WILLIAMS Legal Classification Choices and Decisions 55

56 Ms Amanda WILLIAMS Legal Classification Choices and Decisions 56

57 Dr Simona BADOI Regulatory dimension of the classification of medicinal products in Europe for supply 57

58 Dr Simona BADOI Regulatory dimension of the classification of medicinal Products in Europe for supply 58

59 Dr Simona BADOI Regulatory dimension of the classification of medicinal Products in Europe for supply 59

60 Session theme: Learning about and understanding the differences, needs and expectations of different national healthcare systems and other stakeholders of medicines classification as regards their supply 60

61 Session Chair: Mr Mike MORRIS Irish Medicines Board Speakers: Mag. Thomas BURKHARDT Main Association Social Security Institutions Dr Anna CIEŚLIK Office for Registration of Medicinal Products, Medical Devices and Biocidal Products 61

62 Mag. Thomas BURKHARD The Austrian Health Care System 62

63 Mag. Thomas BURKHARD The Austrian Health Care System 63

64 Mag. Thomas BURKHARD The Austrian Health Care System 64

65 Dr Anna CIEŚLIK Challenges, opportunities and solutions: national differences in medicines classification and supply status 65

66 Dr Anna CIEŚLIK Challenges, opportunities and solutions: national differences in medicines classification and supply status 66

67 Dr Anna CIEŚLIK Challenges, opportunities and solutions: national differences in medicines classification and supply status 67

68 V - BREAK-OUT SESSIONS 68

69 Break out session 1 The classification of medicines in Council of Europe member states and its impact on public health: needs from the perspectives of patients, health professionals and industry expectations as regards support by national authorities and the EDQM (Council of Europe) and its Committee of Experts CD-P-PH/PHO Breakout session moderators & rapporteurs: Group Societal dimension: Ms Merjem HADJIHAMZA, Moderator Ms Irena MEISSNER-WANTUCH, Rapporteur Group Scientific dimension: Ms Irena MEISSNER-WANTUCH, Moderator Mr Fahir BECIC, Rapporteur Group Regulatory dimension: Mr Mike MORRIS, Moderator Ms Amanda WILLIAMS, Rapporteur 69

70 Social dimension of classification Discussion How do differences between countries national decisions on legal classification impact on accessibility of medicines? Would harmonisation be helpful? What are the main types of health reimbursement systems and what impact does their relationship with legal classification have on availability of medicines? There are discrepancies between countries in the level of patients education and self-medication trends. Should we consider these differences in the classification process? What are the possible ways in which legal classification can help to give patients greater empowerment in self care and safe use of medicines including improvements in health literacy? How can patient associations and professional organisations help towards improved accessibility of suitable and safe medicines, in the interests of patients? Scientific dimension of classification Discussion What are the key types of data for a drug to support a switch to OTC status pharmacology, clinical, pharmacovigilance, and safety data on non-prescription supply in other countries? How are the data requirements reflected in the Guideline on changing the classification for the supply of a medicinal product for human use? Should additional safety studies be conducted for a switch application? How can a suitable risk/benefit ratio be established for non-prescription supply? Would trials designed to mimic non-prescription supply be useful to support reclassification applications? What is the role of the Committee in relation to the scientific aspects of classification of medicines? Regulatory dimension of classification Discussion Is there a need for more detailed recommendation of classification in regard of OTC drugs pharmacy only, general sale, internet sale etc? Does OTC status automatically mean that the drug should not be reimbursed by national sick funds is this an issue for MAHs? Dual status of an active substance for the same indication, strength and package size (OTC and List I for example) the role of the Committee should be clarified in this regard. Should the Committee give a more precise recommendation? 70

71 How could a switch decision in 1 MS be used to influence switch decisions in other countries, bearing in mind differences in medical practice, culture and health literacy? Can the Committee help with harmonisation of legal classification in EU and non-eu member states? 71

72 Breakout session 2 Good classification practices the contribution of the Committee of Experts CD-P-PH/PHO Breakout session moderators & rapporteurs: Group (1): Ms Viola MACOLIĆ-ŠARINIĆ, Moderator Dr Simona BADOI, Rapporteur Group (2): Mr Markus PONGRATZ, Moderator Ms Amanda WILLIAMS, Rapporteur 72

73 Discussion How to harmonise the application of relevant EU legislation in the different member states? How to improve the harmonisation of classification decisions? How to harmonise standards for the classification of certain therapeutic classes? Reactive/proactive and structured approach of the authorities to switches? New trends as regards the modes of supply of medicines and their impact on good classification practices? How to extend good classification practices into Europe outside the European Union? Outlook on the impact of the working programme of the Committee of Experts CD-P-PH/PHO, Council of Europe Committee of Ministers Resolution ResAP(2007)1 on e-pharmacy-travel medicine and trans-border healthcare? New EU/EC initiatives in this field, how is the work of the Council of Europe taken into account? Maximisation of impact/impact evaluation : working programme of the Committee of Experts CD-P-PH/PHO? 73

74 VI - EXPERT WORKSHOP CONCLUSIONS 74

75 GOOD PRACTICES FOR THE CLASSIFICATION OF MEDICINES TAKING INTO ACCOUNT THE SOCIAL, SCIENTIFIC, AND REGULATORY DIMENSION OF CLASSIFICATION These good practices for the classification of medicines were agreed by the participants of the Expert workshop Good practices for the classification of medicines as regards their supply which protect public health and promote the accessibility of medicines in Europe, which was held on 8-9 November 2011 on the premises of the European Directorate for the Quality of Medicines and HealthCare (EDQM) (Council of Europe), Strasbourg. The Council of Europe Committee of Experts on the Classification of Medicines as regards their Supply (CD-P-PH/PHO) endorsed these good practices at its 52 nd meeting on March Although the classification of medicines as regards their supply is regulated by European Union and national legislation, there is a need for good practices for the classification of medicines that take into account the social, scientific and regulatory dimensions of classification. - Article 70 of Directive 2001/83/EC of the European Parliament and of the Council, as amended in the Community code relating to medicinal products for human use, provides two obligatory classification categories in principle, i.e. prescription and non-prescription status. Furthermore, it is up to EU member states to establish additional categories and sub-categories, such as those included in Council of Europe Committee of Ministers Resolution ResAP(2007)1 on the classification of medicines as regards their supply 1 (see Appendix 2). - Mandated by a legal instrument, namely Council of Europe Committee of Ministers Resolution ResAP(2007)1 on the classification of medicines as regards their supply, a committee of experts (comprising delegates of member states) annually issues recommendations on the classification and supply conditions of medicines (at the level of medicines therapeutic uses INN (international non-proprietary name) and anatomictherapeutic class - and not at the level of the individual proprietary medicinal products). Although Council of Europe Committee of Ministers recommendations are not legally binding, they represent clear legal guidance ( soft law ) and express political will. These recommendations focus on the promotion of public health, the use of scientific approaches, and take account of the assessments of national competent authorities into the direct and indirect risks that may occur under normal treatment conditions and under medical surveillance, as well as from foreseeable misuse or abuse of medicines. They set a basis for legal standards in member states and help to establish best practices. - The database on the classification of medicines as regards their supply, hosted by the EDQM and supervised by the Committee of Experts CD-P-PH/PHO, provides structured information such as the conditions (e.g. pack size, maximal strength per unit, maximal daily dose) under which a medicine is authorised for supply with or without a prescription in different countries in Europe. The database is updated based on the regular contributions of the Committee s delegations, international and European institutions and stakeholder organisations. Currently, recommendations for about 2,400 medicines at the level of their therapeutic uses - international free name and anatomic-therapeutic class - are published in this database 2 (see Appendix 2). - The Committee of Experts CD-P-PH/PHO is unique in Europe as it is mandated to work towards the harmonisation of classification practices through dialogue and consensus. It provides authorities with a scientific and public health-oriented rationale for the classification of medicines at the level of their therapeutic uses. The recommendations are addressed to Council of Europe member states, whether or not they belong to the European Union (EU). - The classification of medicines that are authorised to be marketed in Europe via national and mutual recognition procedures remains the competency of national health authorities. For EU member states, this was confirmed in Directive 2004/27/EC of the European Parliament and of the Council (31 March 2004)

76 Introduction The availability of medicines with or without a medical prescription has implications for patient safety, patient accessibility to medicines and the responsible management of healthcare expenditure. The decision on prescription status and related supply conditions is a core competency of national health authorities. The conditions of medicine supply vary considerably across Europe due to the fact that legal provisions are interpreted and implemented differently by the competent authorities and because some national healthcare systems link reimbursement to a certain classification status. In light of moves to release more medicines from prescription status, the harmonisation of classification criteria and supply conditions (including warnings, pack sizes and usage restrictions for certain age categories, etc.) is a matter for public health protection. The appropriate classification of medicines is one prerequisite for the best possible medication outcome in individual patients. Responsible management of limited healthcare resources requires ensuring the best possible medication outcomes in the population. The place of self-medication, as one element of a comprehensive approach to good practices for medicine classification comprising also education on healthy lifestyles, prevention and non-medical treatment should be discussed among drug regulators, healthcare professionals and experts in public health and epidemiology. At the expert workshop Good practices for the classification of medicines as regards their supply which protect public health and promote the accessibility of medicines in Europe, held on the 8-9 November 2011 (see Appendix 3), the participants identified key elements for good practices for the classification of medicines: 1. How to harmonise the application of relevant EU legislation in the different member states? How to harmonise standards for the classification of certain therapeutic classes? National differences between healthcare systems or in the supply of medicinal products (pharmacy only versus general sale) are primarily caused by: different attitudes of patients and healthcare professionals across Europe towards self-medication. different use of appropriate measures to ensure the safe and effective use of medicinal products (e.g. product information, naming and pack design, neutral education materials versus promotion and advertisement). different healthcare systems. Additional reasons include different medical and pharmacy practices, availability of over-the-counter medicines (OTC) s, reimbursement policies, and different classifications for medicines in national legislatures. Traditionally in Europe, healthcare systems have been organised either on the basis of the Bismarckian (social health insurance; payer and healthcare provider are separate) or Beveridgean approaches (National Health Service; payer and healthcare provider are the same). Divergences in the application of legislation and classification schemes impacts healthcare and societies. In some countries in Europe, reimbursement of a medicine mainly depends on it being given prescription-only status (Rx). OTC medicines are typically not reimbursable in most countries. This approach aims to reduce the costs for national healthcare budgets by excluding medicines that are considered safe for use without prescription by patients. OTC medicines are used for symptomatic relief; often in self-limiting, minor ailments, but also for symptomatic co-medication in serious diseases. This approach may risk limiting patient accessibility to certain medicines, since they have to pay for the medicines themselves. Thus, linking the reimbursement of medicines 76

77 exclusively to their classification may carry a risk that does not adequately take into account the social and scientific dimensions of medicine classification and the individual needs of patients. An example is OTC anticough medication for children or NSAR analgetics for elderly patients which could pose fianncial burden to small family budgets and possible public health impact in countries with middle or low income levels for many elderly and young families. The social dimension of classification, such as value for consumers compared to non-pharmacological treatments, prevention, adaptation of lifestyles and patient empowerment, is currently not considered effectively. a. Social perspective Good practice: 1. More detailed information about reimbursement possibilities under the given national healthcare system should be compiled, as this can help evaluate the necessity of basing reimbursement status exclusively on medicine classification (Rx/OTC) and/or revising this approach. The criterion for reimbursement of medicines and therapeutic products should be based on the appropriateness and sufficiency of the therapy (i.e. not exceeding what is necessary) and implemented into law. This approach decouples reimbursement from classification status, while ensuring the responsible use of healthcare resources. Example: In Austria, the reimbursement of medicines by the national health insurance system is not linked to their legal status. Separate federal acts regulate reimbursement and classification. Therefore, the reimbursement codex also includes OTC medicines. In Switzerland, obligatory health insurance reimburses all medicines prescribed by a medical doctor that are used according to the patient information leaflet and are included in the list of (reimbursed) medicinal products (liste des specialites/ls). Reimbursement of medicines included in the LS can be limited to certain indications or to a certain quantity. Likewise, magistral preparations (prescribed by a medical doctor, prepared in pharmacies, and which can be composed of preparations, active pharmaceutical ingredients and excipients that are nonreimbursable themselves) are reimbursed. A medicine can be included in the LS if is it authorised by the competent authorities. Medicines that are advertised to the public cannot be included in the LS. b. Regulatory environment Current state of affairs: The European Commission Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use (Revision January 2006) clearly states that the guideline should also be used by competent authorities to facilitate harmonisation (see Appendix 1). However, the switch from prescription to OTC classification is mostly done on the basis of a request from the marketing authorisation holder (industry). This is why medicinal products with the same composition, form, pack size and indications can have different individual classifications on national markets. In some countries in Europe, the WHO s anatomic-therapeutic chemical classification (ATC) has not yet been fully implemented and the ATC guidelines are not adhered to. This makes it difficult to interpret international databases (e.g. the database of the Heads of Medicines Agencies) and national lists of Rx and OTC medicines. In regulatory practice, medicine safety is the key criterion influencing the decision to switch from Rx to OTC status. Safety considerations are based on scientific (including epidemiological) reasoning. In the case of medicines with a long history of use ( traditional use ), safety data are scarce and date back a long time. Given the specific focus of the current pharmacovigilance system on severe unlabeled adverse drug reactions, the low overall reporting discipline for such events and its relevance for OTC medicines, available 77

78 safety data should be reviewed using state-of-the-art approaches, where necessary. Adverse reactions caused by OTC medicines are rarely reported via established pharmacovigilance systems. If a medicinal product authorised via the MRP/DCP 3 is switched from Rx to OTC status and requires modification of an approved indication (deletion or re-wording), the patient information leaflet, Summary of Product Characteristics (SmPC), inner and outer packaging labels also have to be modified as the SmPC has to be identical in all EU member states concerned by the MRP/DCP procedure. Therefore, the marketing authorisation holder should change the SmPC in all EU member states where the medicinal product has been authorised via the MRP/DCP procedure, before applying for a change in classification. Marketing authorisation holders do not always chose this strategy since, for marketing reasons; they may prefer to have a given medicinal product with a different classification in individual markets. The Drug Regulatory Authorities (DRAs) of some member states will not accept variations of medicinal indications, which can lead to deviations from the agreed reference SmPC. As a consequence, marketing authorisation holders often apply for a duplicate marketing authorisation for an OTC medicine, rather than requesting a change in the legal status via a national variation application. Example: CMDh guideline: Good practice: 2. National DRAs should proactively review therapeutic classes of medicines and recommend those that are safe and appropriate for OTC use. Inter-disciplinary consultations with health professionals, public health scientists and industry should inspire the decisions and create awareness of the social context of classification. 3. Adherence to the WHO ATC guidelines and ATC classification in international databases and national inventories of Rx and OTC medicinal products should be fostered by national and European DRAs. Use of ATC codes for combination medicines in such inventories (e.g. the database of the Heads of Medicines Agencies) should be standardised. Example In order to harmonise the legal status of medicines with the same active pharmacological substances in the Czech Republic, the Czech DRA has started reviewing selected therapeutic classes in order to ensure the same Rx or OTC status for all authorised medicines belonging to the respective class. In the first phase, products containing cetirizine and low-dose acetylsalicylic acid were reclassified as OTC. Other medicines to be reclassified in the future include: levocetirizine, loratadine, glucosamine, silymarin, azelaic acid and cromoglycic acid. 4. Authorities should foster a regulatory environment that provides incentives for industry to develop and market OTC medicines that are not only safe, but provide value for patients (efficiency) while preventing the development of unrealistic expectations and over-medication. 2. How best to meet patients needs and expectations of quality of life? Current state of affairs: Usage and therapeutic classes of OTC medicines is increasing; not only for acute diseases but also for chronic conditions, implying long-term use. 3 Mutual Recognition/ Decentralised (Marketing Authorisation) Procedure (MRP/DCP) 78