1. 1 HEALTH LITIGATION AND NEW CHALLENGES IN THE MANAGEMENT OF PHARMACEUTICAL SERVICES Vera Lucia Edais Pepe Tatiana Aragão Figueiredo Luciana Simas Claudia Garcia Serpa Osorio-de-Castro Miriam Ventura verapepe@ensp.fiocruz.br 1 Third International Conference for Improving the Use of Medicines Informed Strategies, Effective Policies, Lasting Solutions November 14-18, 2011. Antalya, Turkey

2. 2 Problem Statement Pharmaceutical Services (PS) have gained importance in the Brazilian Health System (SUS) after the establishment of the National Medicines Policy (PMN), in 1998. This importance has been reinforced in the First National Conference on Medicines and Pharmaceutical Services, in 2003, and in the National Pharmaceutical Services Policy (PNAF) in 2004. In 2006, PS were assigned as a specific funding block in SUS, with 3 Components: Basic medicines (primary health care); Strategic medicines (HIV / AIDS, tuberculosis, leprosy, leishmaniasis, malaria, systemic lupus erythematosus, multiple myeloma etc); Specialized medicines (treatment of high-cost or rare diseases and for highly prevalent conditions in which first- line treatment is not enough); access on an outpatient basis, with diagnostic and therapeutic criteria established in Therapeutic Clinical Protocols and Guidelines of the Ministry of Health – PCDT.

3. 3 Problem Statement Despite efforts and progress in PS there is still a portion of Brazilians who are excluded from access to medicines. As a result, legal actions have arisen as a means to guarantee access to these technologies through SUS. Ferraz OLM. The right to health in the courts of Brazil: Worsening health inequities? Health and Human Rights 2009; 11(2): 33-45

4. 4 Objective This work proposes to better understand one of the aspects of health litigation, namely the growing use of lawsuits demanding medicines, and the relationship between this phenomenon and pharmaceutical services management in the Brazilian Health System.

5. 5 Methods (1) Narrative review. Search terms were: "drug/medicine", "lawsuits", "pharmaceutical services", "national medicine policy, "health litigation" ; (2) Selected articles, dissertations and theses (in Brazil) since 2000; (3) Databases: LILACS, SciELO, Portal de Teses da CAPES; (4) Descriptive research in Portuguese and English were considered; (5) The analysis discusses the main elements of "medicines litigation" examined in light of their interference on the activities of the pharmaceutical services cycle; (6) Measures are proposed for helping the decision-making process by health managers and professionals of the justice system.

6. 6 Results Health litigation is a multifaceted phenomenon and literature postulates three negative effects. 1)the absolute deferment of medicines demands by the Justice System: deepen inequities by favoring those who have more possibilities of accessing the judicial system; 2)the difficulties in the management of pharmaceutical services: the intensity of litigation may interfere with the fulfillment of the activities of the Pharmaceutical Services Cycle.

7. 7 Health managers tend to create a parallel structure to respond to judicial and administrative demands, using makeshift procurement procedures, resulting in more expenses in acquisition of medicines. Adapted from Oliveira et al, 2007; Figueiredo, 2010

8. 8 Results 3) patient safety: non-rational prescribing and use of medicines, especially when there is a prescription of a new medicine or new therapeutic indication for which there is no established scientific evidence.

9. 9 Results Decision-making in the wake of lawsuits is complex, involving elements that reach beyond technical and administrative factors. Careful analysis of medicines prescriptions, which underlie the judicial order constitutes an important limitation related to the use of the courts in ensuring access to medicines.

10. 10 Results Figure 1 shows the decision-making flow resulting from a lawsuit, considering that medicines must be provided with the best available evidence on efficacy and safety, vis-a-vis its therapeutic indication. It presents possible mechanisms to be adopted in decision-making by managers and professionals in both health and justice system.

11. 11 Results

12. 12 Conclusions Health litigation spurs many challenges in the management of pharmaceutical services (PS). Performance of health managers and decision makers must be adjusted to new administrative and legal boundaries. Their actions must also be efficient in responding to ongoing lawsuits, as well as in avoiding additional litigation and in upholding principles and directives of the Brazilian Health System (SUS) It is necessary not only to identify the difficulties which lead to legal action, but also to create conditions for the health system managers and for the legal system to operate toward developing strategies, tools and mechanisms to improve PS and to reduce the intensity of litigation.