MEDICINES PROMOTION AND RATIONAL USE : The Spanish Experience JOSE LUIS DOPICO

Transcription

1 MEDICINES PROMOTION AND RATIONAL USE : The Spanish Experience JOSE LUIS DOPICO

2 LEGAL FRAMEWORK General Health Act (1986): Established a National Health System in Spain in accordance with the following principles: - Universal and free access to health care. - Management system decentralized at regional level. - Equal for all citizens having access to health care services and supplies across the Spanish territory.

3 LEGAL FRAMEWORK (II) Directive 2001/83/CE, ammended by directive 2004/27/CE. 29/2006 Act (july 26th), of guarantees and rational use of medicines and health products 1416/1994 Royal Decree (June 25th). Regulates medicines promotion, ammended by 109/2010 Royal Decree (february 5th).

4 DEFINITION OF ADVERTISING GENERAL DEFINITION: every form of communication made by a natural or legal person (either public or private) active in commercial, industrial or professional activity with the purpose of engaging any kind of goods or services, rights and obligations (art. 2, Advertising General Act, ). MEDICINES PROMOTION: every form of information offer, prospection or stimulus aimed at promoting the prescription, dispensing, sale or consumption of medicines (art. 1 Royal Decree 1416/1994).

5 GENERAL PRINCIPLES The promotion of any medicine that has not obtained the marketing authorization is forbidden. Every promotion element must be adjusted to the information contained in the technical file of the medicine. Medicines promotion must favor rational use of medicines and healthcare products in all cases. The promotion shall not be misleading.

6 RATIONAL USE OF MEDICINES Strategy aimed at achieving that each patient receives timely the convenient medicine, in dosage and pharmaceutical presentation, according to his/her clinical status, during the needed period of treatment and at the lowest possible cost.

7 CONCEPT OF RATIONAL USE OF MEDICINES It contains two different aspects: 1- Health aspect. 2- Economic aspect. Both of them must be considered in pharmaceuticals policies oriented to the rational use of medicines.

8 EVOLUTION OF PHARMACEUTICAL EXPENDITURE IN SPAIN (In millions E) (*)

9 % EVOLUTION OF PHARMACEUTICAL EXPENDITURE

10 INDUSTRY CONTRIBUTION TO THE NATIONAL HEALTH SYSTEM Contribution scheme 29/2006 Act (additional provision nº 6) Quarterly sales volume (in official prescription) contribution Up to 3 Millions.1 5 % From 3 Millions.2 0 %

11 OBJECTIVES of CONTRIBUTION Biomedical research (I.S.Carlos III). The remainder is to be applied to: - Training programs for health professionals. - Health education programs for the citizenship (as campaigns for responsible use of antibiotics, or use of generic medicines). - Health consistency policies (promotion of non-commercial clinical trials, attention to polypharmacy programs).

12 ADVERTISING CAMPAIGN

13 MEDICINES PROMOTION The medicines promotion can be addressed: * To the general public. * To health professionals.

14 INFORMATION on MEDICINES 29/2006 Act (art. 76): objectivity and quality of information addressed to professionals. - Under control of health authorities. - Must be in accordance with the technical and scientific information approuved by the Spanish Medicine Agency. - Adapted to the technical file of the medicine.

15 INFORMATION on MEDICINES (II) CONCEPT: knowledge and technical system that allows data and experiencies communication about medicines with the goal of promoting their rational use.

16 INFORMATION on MEDICINES (III) TYPES Active: consultations (websites). Passive: publications (Therapeutic Information Bulletin of the National Health System).

17 INFORMATION on MEDICINES (IV) THERAPEUTIC INFORMATION BULLETIN: - Periodic publication aimed to favor the rational pharmatherapy through works and revisions enhancing aspects of efficacy, security and economic costs in the use of medicines. - Characteristics: independent, simple and addressed mainly to prescribers.

18 MEDICINES PROMOTION 29/2006 Act (art. 78): guarantees in medicines advertising adressed to the general public. Advertising is banned in the following cases: - Medicines financed with public fund. - Prescription medicines. - Psychotropic or narcotic substances.

19 AUTHORIZATION PROCEDURE Adapted to the Directive The assessment focuses on two aspects: - Pharmaceutical evaluation (SPC). - Requierements of the promotional message.

20 AUTHORIZATION PROCEDURE (II) Competent authority: Directorate General for Pharmacy and Health Products (final decision). Previous Health Control (working group): - Administration representative. - Industry representative. Proposals: - Authorization. - Conditional authorization. - Rejection.

21 SUMMING UP Medicines promotion must favor their rational use in any case. Promotion can be addressed to health professionals or to the general public. Medicines information to professionals: -Active. - Passive. Medicines promotion is aproved through administrative procedure.

22 THANK YOU