Rapid Increase of Health Litigation As A Means of Market Access For Innovative Medicines In Colombia And The Potential Role Of Health Technology Assessment

Abstract

Reimbursement of high-cost medicines excluded from the Colombian mandatory healthcare plan (POS) through legal mechanisms known as ‘tutela’ and the Scientific Technical Committees (CTC) have significantly increased in the last four years. As the new healthcare statutory law (1751-2015) puts pressure on the healthcare budget, it is likely that these will increase further. This research analyses the “judicialisation” of the right to health in Colombia and the feasibility of a mandatory health technology assessment (HTA) evaluation as a policy to reduce reimbursement of non-POS medicines by litigation. Secondary research of the main tutela decisions of the Colombian courts and CTC decisions related to non-POS medicines between 2011 and 2014 were conducted. A 2014 Ombudsman’s Office report of detailed medicine-tutelas was also analysed, and cross-referenced with statistics from the Colombian Ministry of Health and the General Prosecutor. A lack of official data for 2014 is addressed using case-by-case tutelas, literature review and stakeholder interviews. Tutela and CTC decisions are predominantly in favour of protecting the fundamental right to health (80% of all decisions between 2011 and 2014), giving access to non-POS medicines irrespective of cost-effectiveness. According to the Ombudsman’s Office, of the 115,147 tutelas presented in 2013, 34,099 (18.8%) were requests for medicines of which over half (22,685) were for access to non-POS medicine. The Colombian Fund of Solidarity and Guarantees paid health-promoting entities (EPS) over COP2 billion in 2012 and over 2.5billion in 2013 for the reimbursement of non-POS medicines following tutela and CTC decisions. Decisions over access to many high-cost medicines in Colombia are taken in courts based on infringement of fundamental rights rather than on cost and clinical-effectiveness assessments. This provides an important avenue to access new medicines, but also side-steps the formal reimbursement process. A more systematic, binding HTA system would likely reduce health litigation.