BULGARIAN PHARMACEUTICAL POLICY AND LEGISLATION IN THE CONTEXT OF THE EU ACCESSION

Transcription

1 BULGARIAN PHARMACEUTICAL POLICY AND LEGISLATION IN THE CONTEXT OF THE EU ACCESSION DR SVETLANA SPASSOVA DIRECTOR NATIONAL HEALTH POLICY MINISTRY OF HEALTH European Health Conference 29th September 2006

2 National Pharmaceutical Policy Aims to ensure balance between the: - needs of the population of qualitative, safe and effective drugs - interests of various stakeholders in society and the pharmaceutical branch - available financial resources

3 Main stakeholders in the pharmaceutical policy: Legislative and executive state organs Ministry of Health Drug regulatory authority; Health-insurance funds; The pharmaceutical manufacturers Bulgarian and foreign; Wholesalers and retailers of drugs; Professional-branch organizations, associations and guilds; Various public structures and organizations.

4 The most important stakeholder THE PATIENT cross point of the complex relations between the participants in the pharmaceutical market

5 The pharmaceutical branch: - Factor in the national economy - Factor in the national health system

6 Characteristics of the pharmaceutical branch: - Dynamic system - Various responsibilities; - Different expectations; - Multidirectional interests

7 Elements of the national pharmaceutical policy Legislation Organizational structure Financial and human resources Capacity building Monitoring and contro

8 Drug Usability Marketing, distribution, prescription and use of the drugs in society with special accent on the medical, social and economical outcomes from their use.

9 import volumes continuous increase

10 Drug Product Consumption Value 7.00E E E E E E E E E E E E+08 DP-import DP-local manufacture TOTAL 2.00E E E E E E E E Quantitative indices

11 Drug Product Consumption number of packages 2.50E E E E E E E E E E E+08 DP-import DP-local manufacture 1.00E+08 TOTAL 5.00E E E E E E

12 Drug Products Path - Market Accessibility Slow administrative order for access to the Bulgarian market of imported and locally manufactured new innovative and generic drug -duration of access procedure from 1 to 3 years national procedure -210 days; centralized procedure -90 days; price commission to CM -90 days; positive drug list -once per year; reimbursement list NHIF - once a year;

13 Present weaknesses: Increased drug usability indices and value of pharmaceuticals; Increased healthcare expanditures on pharmaceuticals; Slow access of pharmaceuticals to the market; Several reimbursement lists; Not well defined responsibilities of the participants in the market; Low satisfaction of the patients and the population;

14 Accession of Bulgaria to EU New Law on Medicines in Human Medicine Developed in line with: Treaty of accession Transposition of EU legislation

15 European Acts Taken into Consideration Consolidated Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directives 2002/98/EC, 2004/24/EC and 2004/27/EC

16 European Acts Taken into Consideration Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products

17 European Acts Taken into Consideration Council Directive 89/105/EEC,, of 21 December 1988, relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national health insurance systems Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State

18 New Law on Medicines in Human Medicine INTRODUCES: New Marketing Authorization (MA) procedures -Mutual recognition procedure (MRO), Decentralized Procedure (DP) Specific requirements for Homeopathic Medicinal Products (HMP) and Traditional Herbal Medicinal Products (THMP) Law 1995 does not stipulates them explicitly; Law 2006 settles the relevant MA procedures Clear definition of responsibilities and rights of MA Holder Qualified Person for manufacturing and import Parallel Import - a mechanism of price equalization

19 New Law on Medicines in Human Medicine New Law 2006 New Law chapters, 296 articles (*Previous Law chapters, 114 articles) Chapter I - Scope Chapter II Marketing Authorization Chapter III Clinical Trials Chapter IV Manufacturing Authorization and Import Authorization of Medicinal products Chapter V - Labelling and Package Leaflet Chapter VI Classification of Medicinal Products Chapter VII Pharmacovigilance Chapter VIII Wholesale Distribution and Parallel Import of MP NEW!!! Chapter IX Retail Distribution of MP Chapter X Advertising of MP Chapter XI- Prices of MP Chapter XII - Control Chapter XIII Administrative-Criminal Orders

20 New Law on Medicines in Human Medicine Chapter I Scope Specifies: cases when the Law shall not be applied persons carrying responsibility for treatment with non-authorized products, terms of temporary import permission of non- authorized products, Brings in a prohibition principal to medical products outside the e Law under question and Regulation (EC) 726/2004 to be subjects of manufacturing, import, wholesale and retail trade, advertising, and to be used for treatment, diagnostics and prophilaxis. bodies implementing the drug policy Ministry of Health, Bulgarian Drug Agency Bulgarian Drug Agency s s activities, authorizations, as well as the obligation to maintain a system of electronic exchange of data bases b with Member States Regulatory Bodies, European Commission, European Medicines Agency /EMEA/, and the way of BDA financing

21 New Law on Medicines in Human Medicine Chapter II Marketing Authorization Specifies the requirements for application for MA CTD format (testing results readability) Settles Data exclusivity A 10 - year protection period for preclinical and clinical data of the original medical product (meant to be used as referent ) A 1 year extension of the 10 - year period in case that during the first 8 years after obtaining an MA for the medical product (meant to be used as referent ), the MA holder obtains an authorization for a new therapeutic indication with significant clinical advantages (8+2+1 rule) A generic application is possible when the referent medical product is/has not been authorized in Bulgaria: the applicant should indicate icate at least 1 EU MS where the medical product is/has been authorized BDA demands a confirmation from the regulatory body in the indicated MS, as well as information on the qualitative and quantitative content of the medical product and additional information, if necessary BDA provides the same confirmation and information on request by a regulatory body in a MS where a generic application has been made for a referent medical product already authorized in Bulgaria

22 New Law on Medicines in Human Medicine Chapter II Marketing Authorization Settles the well-established established use No results from pre-clinical tests and from clinical trials are required if the applicant can demonstrate, through a detailed reference to published scientific literature, that the active substance of the e medical product has a well-established established medicinal use with recognized efficacy and acceptable level of safety Results of pre-clinical tests and of clinical trials are required in case of a combination medical product, when the active substances have not n been used before in the proposed combination Where an active substance, with a well-established established use, has a new proved therapeutic indication on the bases of significant pre-clinical and clinical data, a new applicant should not refer to such data Settles the Bolar Provision Active patent or SPC are not obstacles for undertaking pharmacological and clinical pharmacology trials, necessary for applying for a MA and following practical requirements related to MA of generic products

23 New Law on Medicines in Human Medicine Chapter II Marketing Authorization Specifies the types and defines the mechanism of marketing authorization procedures: National, Mutual Recognition procedure, makes reference to Centralized Procedure Works out in details variations Brings in MA line extension Specifies the terms Settles simplified procedures for registration of Homeopathic products without therapeutic indication and Traditional Herbal Products and specifies BDA s s activities related to them

24 New Law on Medicines in Human Medicine Chapter III Clinical Trials (CT) specifies: Protection of clinical trials subjects Minors Incapacitated adults Clinical trial sites: hospitals and dispensaries with positive rating after accreditation procedure Ethics Committees: Local Ethics Committee at the clinical trial site, gives opinion for CT conducted within the site Multi-centre Ethics Committee gives opinion of multi- centre CT Central Ethics Committee where to appeal against the decisions of the Local Ethics Committees Particular cases where BDA gives opinion on conducting CT

25 New Law on Medicines in Human Medicine Chapter IV - Manufacturing Authorization and Import Authorization of medicinal products: A manufacturer/ importer within the territory of Bulgaria is registered as a trader within the territory of the EU and has manufacturing authorization issued by BDA Manufacturer/ importer responsibilities Requirements and procedures for issuing manufacturing/ importation authorization New figure qualified person,, (responsibilities details)

26 New Law on Medicines in Human Medicine Chapter V Labelling and Package Leaflet, new points: Active substance, strength and pharmaceutical form on the secondary package to be in Braille, too (for newly authorized medical products) Labelling of medical products containing radionuclides Medical products subject to medical prescription MP on medical prescription for renewable/ non-renewable delivery MP on medical prescription to special medical prescription MP on restricted medical prescription MP not subject to medical prescription (OTC MP) - delivered in pharmacies and drug stores.

27 New Law on Medicines in Human Medicine Chapter VII Pharmacovigilance, specifies: MA Holders s obligation to organize and maintain a system for: monitoring, recording and reporting of adverse drug reactions (ADR) taking urgent safety actions, if necessary

28 New Law on Medicines in Human Medicine Chapter VIII Wholesale Distribution and Parallel Import Wholesale distribution authorization issued by BDA Parallel Import - (PI) in terms of: MP within the scope of PI Application for PI documentation requirements BDA obligations: to check the conformity of documentation within 45 days; surveillance in terms of quality, efficacy and safety Parallel Import Authorization Holder obligations Competent authority issuing PI authorization BDA for 5 years

29 New Law on Medicines in Human Medicine Chapter X Advertising of MP specifies in a more detailed manner MAH obligations to maintain a scientific unit for dissemination of information on the MPs with MA offered BDA s s obligations to complete an expertise, to prepare a written statement, and to issue a regulatory decision

30 New Law on Medicines in Human Medicine Chapter XI Prices of MP: Specifies mechanism of regulation on MP prices and working out of Positive List as one simplified system of bringing in MPs on the national market and in the health care system Settles Positive List main parts Defines Positive List inclusion criteria Transposes Council Directive 89/105 in terms of transparency

31 New Law on Medicines in Human Medicine Chapter XII Control: Specifies the competences and power of the controlling institutions Ministry of Health, Bulgarian Drug Agency, regional bodies Chapter XIII - Administrative-Criminal Orders Increased fines and properties sanctions

32 European vision New European Pharmaceutical Policy LISBON AGENDA/ PARTNERSHIP FOR GROWTH & JOBS KNOWLEDGED BASED ECONOMY INNOVATION COMPETITION G10 MEDICINES PROCESS INFORMATION TO PATIENTS RELATIVE EFFECTIVENESS PRICING/REIMBURSEMENT PHARMACEUTICAL LEGISLATION

33 European vision G10 MEDICINES PROCESS FIRST PHARMACEUTICAL FORUM 29 TH, September 2006 INFORMATION TO PATIENTS Improving patient access to high quality information on disease and medicines Develop guidance in Europe on the production of high quality & easily understandable and accessible information on disease and medicines PRICING AND REIMBURSEMENT Ensuring control of pharmaceutical expenditure for MS Ensuring a timely and equitable access to medicines for patients all over Europe Ensuring a reward for innovation RELATIVE EFFECTIVENESS Identify the most valuable medicines, both in terms of clinical efficiency as of cost- effectiveness

34 National Health Strategy- PRICING AND REIMBURSEMENT Developing legislation for binding the pricing system with the reimbursement system, subordinating them to common mutual relations, principles and integrated information services. Bringing the pricing and reimbursing system in accordance with the requirements of Directive 89/105/EЕC. Implementation of a regulatory base for gradual transition from indirect (separated pricing and reimbursement policy) to direct price control (integrated pricing and reimbursement policy).

35 National Health Strategy In other words, uniting all administrative pricing procedures in an integrated POSITIVE-REIMBURSEMENT LIST.

36 National Health Strategy PRICING AND REIMBURSEMENT Positive Drug List (PDL) 1. Valid for all health and medical establishments using public finances. 2. Combining all acting at present drug lists in BG. 3. Developed by АТС, ІNN, dosage form,, referencer price by DDD. 4. Drugs Developed in four parts: - part one paid by NFHI - part two for hospital care - part three for treatment of cancer diseases - part four for rare diseases,, AIDS A and infectious diseases

37 National Health Strategy PRICING AND REIMBURSEMENT PDL Local prices of innovative and generic drugs imported or locally manufactured, determined after comparative analysis of international data Annual publication of the Positive Drug List with periodic update during the year

38 National Health Strategy -RELATIVE EFFECTIVENESS Identification of most valuable medicines, both in terms of clinical efficiency as of cost- effectiveness Development and implementation of guideline for pharmaco-economicl analysis of drugs Development and implementation of therapeutic guidelines for rational use of drugs. Optimal territorial provision of pharmaceuticals by pharmacies

39 National Health Strategy INFORMATION TO PATIENTS Access to information from international sources concerning quality, safety and efficiency of the drugs. Iimplementation of contemporary systems for independent drug information. Development of information connections between MH, BDA, NHIF, as well as own information systems in accordance with the regulated activities.

40 National Health Strategy Capacity Building Financing and organizing training on rational drug prescribing (RDP) at regional and national level. Qualifying the regulatory administrative personnel, according to EU requirements in the field of manufacturing, distributing and supplying of drugs. Organizing a system of educational programs for training and qualifying of specialists in the field of the economical aspects of the drug policy.

41 National Health Strategy Transparency, Monitoring and Control Transparency procedures - One counter service for example, all applications to be submitted in BDA simultaneously with the application for marketing authorization! Monitoring drug prescription and usage Control over pharmaceutical expenditure

42 Thank You