Third International Conference for Improving the Use of Medicines
Informed Strategies, Effective Policies, Lasting Solutions
November 14-18, 2011. Antalya, Turkey
HEALTH LITIGATION AND NEW CHALLENGES IN THE
MANAGEMENT OF PHARMACEUTICAL SERVICES
Vera Lucia Edais Pepe
Tatiana Aragão Figueiredo
Claudia Garcia Serpa Osorio-de-Castro
• 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 firstline 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.
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
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.
(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.
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
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.
Organization & Planning
Monitoring & Evaluation
Adapted from Oliveira et al, 2007; Figueiredo, 2010
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.
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.
Decision-making in the wake of lawsuits is complex,
involving elements that reach beyond technical and
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.
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
It presents possible mechanisms to be adopted in
decision-making by managers and professionals in
both health and justice system.
• 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.