1. TAIEX Workshop on the Implementation of EU Pharmacovigilance Legislation - BELGRADE 2015 - CLAUDIA PANAIT TAIEX Expert – European Commission Legal Adviser Ministry of Health, ROMANIA

2. WHAT HEALTHCARE PROFESSIONALS AND PATIENTS CAN EXPECT FROM THE IMPLEMENTATION OF THE NEW EU PHARMACOVIGILANCE LEGISLATION ?

3. Key provisions for patients in the new EU legislation Directive (Directive 2010/84/EU) and Regulation (Regulation No. 1235/2010)  amend the existing EU legislative framework Directive 2001/83/EC and Regulation 726/2004, only as regards pharmacovigilance  adopted by the Council of the European Union on 29 November 2010 without debate, having reached agreement with the European Parliament on first reading  published in the EU Official Journal on 31 December 2010.

4. Transposing EU Regulation and Directives into national legislation  EU Regulation is directly applicable and binding to every Member State  Directives require a formal legislative act in order to be to transposed them into national law The New Pharmacovigilance Legislation is an important step for medicines safety but also for patient involvement !

5. The main pillars of the new EU legislation  Risk management  Rafety data  Stronger link between safety assessments and regulatory action  Transparency, communication and patient involvement  Clear tasks and responsibilities for all parties  Improved EU decision-making procedures  New scientific committee at the European Medicines Agency: The Pharmacovigilance Risk Assessment Committee

6. Adoption of revised pharmacovigilance legislation  Definition: Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks.  It is essential for protection of public health !

7. New amendments to the EU legislation  Now the use of medicines in the EU is even safer !  Patients and healthcare professionals will be specifically informed and asked to notify adverse reactions to the medicine!

8. Institutions involved in the field of pharmacovigilance  COMPETENT AUTHORITY (CA) =government of a member state to act in order to ensure that the requirements of directive (directives) in this field are met  POLITICAL ORGANIZATION = responsible for policy is the body authorized by the

9. In Romania: National Agency for Medicines and Medical devices (NAMMD) Competent Authority (CA) : NATIONAL AGENCY FOR MEDICINES AND MEDICAL DEVICES (NAMMD) - responsible for pharmacovigilance activity  The NAMMD has implemented an electronic data exchange system regarding suspected adverse reactions using the webtrader component of EudraVigilance Web Application (EVWEB)

10. In Romania: MINISTRY OF HEALTH Political Organization : MINISTRY OF HEALTH - responsible for policy NEW EU PHARMACOVIGILANCE LEGISLATION  Healthcare professionals and patients are also involved

11. Those directly involved in pharmacovigilance  Patients  Doctors, pharmacists, nurses  Regulatory authorities  Pharmaceutical companies and companies importing or distributing medicines

12. How will the new Pharmacovigilance legislation ensure greater patient safety?  Clear tasks and responsibilities for all parties involved (MS, marketing authorisation holders and the European Medicines Agency)  Improving decision-making procedures  Using resources more efficiently  Managing risk proportionately  Involving stakeholders in pharmacovigilance including through direct patient  Reporting  Communication and transparency on medicine safety  Companies’ pharmacovigilance systems

13. How will this legislation ensure greater transparency and patient involvement?  Patients + healthcare providers : to reports ADRs directly to the competent authorities.  National authorities : web-portals  MS: regular reports to "Eudravigilance“  Public hearings on medicines:announced on the European web portal.  Patients : to express themselves to be more active participants in their health identifying patterns of ADRs.

14. What is the Committee on Pharmacovigilance that will be set up under this legislation? The Pharmacovigilance legislation: a new scientific committee at the European Medicines Agency:  ”Pharmacovigilance Risk Assessment Committee (PRAC)” : access to the best scientific and medicinal expertise for the evaluation of the safety of medicines and risk minimisation measures with the ultimate goal of reducing ADRs.

15. Appointments Are based on relevant experience in pharmacovigilance and risk assessment. The committee is composed of:  - 1 member and 1 alternate appointed by each Member State  - 6 members appointed by the Commission to ensure availability of relevant expertise in the committee, on the basis of a public call for expression of interest  - 1 member and 1 alternate appointed by the Commission on the basis of a public call for expression of interest in order to represent healthcare professionals  -1 member and 1 alternate in order to represent patients.

16. Impact on patient organisations at national and EU level  At European level, EPF working with the Commission, other stakeholder groups (doctors and pharmacists) and monitoring the implementation of the new legislation.  At national level, the legislation does not directly oblige MS to involve patient organisations, but it does encourage this.

17. In Romania: periodic meetings between patient associations and NAMMD  Participants representing patient associations promote the patient reporting form as well as their availability for posting it on their respective websites.  The NAMMD encourages both patients and healthcare professionals to report suspected adverse reactions to all medicines, vaccines included.  By reporting adverse reactions, patients can help improvement of the drug safety profile, protecting public health.  The patient reporting form: on the NAMMD website http://www.anm.ro/anmdm/med_reactie_adversa.html.

18. Guidance for Patient Organisations The new EU pharmacovigilance legislation: Directive 2010/84/EU and Regulation No. 1235/2010

19. Purpose  information and guidance for patient organisations on the EU pharmacovigilance legislation  aspects of the legislation that have particular implications for patients

20. Why is pharmacovigilance important for patients?  Adverse drug reactions : the fifth largest cause of deaths in hospitals (only around 10% to 25% of all adverse reactions are reported)  Patients and healthcare professionals are currently underreporting

21. Improve the safety and quality of care  clear EU-wide rules on pharmacovigilance and  ensuring effective cooperation between Member States for all medicines sold in more than one Member State IS FUNDAMENTAL !

22. The new EU rules  improve the collection of information on adverse reactions  bring new ways to encourage reporting  more options for patients

23. The competence of the EU to legislate in the field of pharmacovigilance Limited competence  Generally only adopts non-binding legislative instrument (recommendations and communications)  Specific areas: binding legislation to harmonise national laws (to set high standards of quality and safety for medicines and medical devices)

24. Responsibility for organisation of health systems: Member States National Competent Authorities (NCA) Their task:  to evaluate all information scientifically risk minimisation  prevention and take action regarding the marketing authorization (revoke it, or not renew it).  ask for more information from the company that holds the authorization.

25. The role of patients and health professionals = the key to building a better system of pharmacovigilance  Patients are best placed to assess the impact of a medicine on their bodies and their quality of life

26. High quality of information to patients is crucial  good information on medicines and adverse drug reactions can empower patients to participate more actively in healthcare decisions, together with health professionals.

27. A good patient-health professional relationship  Trust and mutual respect = crucial to ensure that patients are comfortable discussing the effects of medicines with their doctor or other health professional.   Systems for direct reporting of suspected adverse reactions by patients (or consumers) already operate in some EU Member States, notably the Romania, UK, Denmark and Netherlands.

28. The new EU rules  Will allow direct patient reporting in all EU Member States  Giving patients this possibility will be empowering

29. Reporting the adverse reactions =an important way to collect more information The regulatory authorities :  analise the adverse reactions reports  together with all the information they already have, The patients and the medical staff are encouraged to report the suspected adverse reactions related to any medicinal product.

30. In compliance with the new legislation The patients :  report the adverse reactions directly to the national authorities in the medicinal products field of their countries The modality of transfering such notifications : the leaflet of each medicinal products and in the Summary of product characteristics.

31. Quick identification = The black triangle  The patients and medical staff are encouraged to report any suspected adverse reaction related to the medicinal products bearing the black triangle

32. Patient reports are as valuable as reports by healthcare professionals Special added value:  patients are able to specify the circumstances in which the reaction occurred  they often give much more detailed and nuanced descriptions

33. Different types of reactions  Patients also report different types of reactions than health professionals  they perceive the impact and severity of reactions differently

34. Better information on pharmacovigilance to the public  greater transparency of the pharmacovigilance system  better access to information  the confidence and trust of patients and the general public.  national medicines web-portals linked to a European medicines portal (developed by the EMA)

35. National medicines web-portals  Publicly available versions of the assessment reports with their summaries  Summaries of product characteristics  Package leaflets  Summaries of the risk management plans for authorised medicinal products  The list of medicinal products that are subject to additional monitoring  Information on the different ways of reporting suspected adverse reactions to the national competent authorities by healthcare professionals and patients

36. European medicines portal, developed by the EMA  information about the EMA Pharmacovigilance Risk Assessment Committee and its meetings;  post-authorisation studies;  summaries of risk management plans;  information about Union reference dates and frequency of submission of periodic safety update reports;  protocols and public abstracts of results of the post-authorisation safety studies;  information on the initiation of urgent union procedures

37. Eudravigilance database  Partially accessible to the public, health professionals and research organisations. EPF has been actively contributing to an EMA working group to advise on the implementation of the Eudravigilance access policy to ensure the clarity and user !

38. Encouraging reports by adverse drug reactions MS :  “may” involve patient organisations to encourage reporting by patients  have to provide at least one other way for patients to report directly to the national competent authorities Patient organisations :  can offer help in preparing guidelines for implementation of direct patient reporting

39. Transparency on pharmacovigilance - public awareness Patient organizations  can give advice concerning the set-up of national medicines web-portals to ensure the information is clear, meets patients’ needs and is user-friendly  can suggest other information that would be useful to include although not strictly required by the rules.

40. Patient organisations play a key role  In addition to public information campaigns, patient organisations play a key role supporting long-term patient awareness about pharmacovigilance, as they are in regular and close contact with grass-roots patient communities. ! Make sure the national authorities are aware of Patient organizations activities and their added value.

41. Conclusions What healthcare professionals and patients can expect from the implementation of the new eu pharmacovigilance legislation?

42. Expectations  Reducing medication errors from pharmacovigilance perspective  Minimising risk  Minimising risk for a new presentation of a existing medicine  Involvement of authorities for reducing medication errors  Reducing the incidence of medication errors

43. THANK YOU FOR ATTENTION !