School’s in Session at the Latin American Patient Academy

1. Regulations
2. Evaluation of Health Technologies (ETS)
3. Research and Development and Clinical Trials

The academy’s first face-to-face meeting welcomed 22 leaders from eight countries, representing disease states that included cancer, diabetes, transplants, cardiovascular, rare diseases, autoimmune diseases, psoriasis, rheumatoid arthritis, multiple sclerosis, and HIV, among others.

Presentations explored the challenges of drug regulation in the region and included several presentations.

Counterfeit Medicines

Geoffroy Bessaud[1] presented on counterfeit medicines, which is a serious problem in Latin America. To make the issue more visible, the International Federation of Pharmaceutical Manufacturers & Associations is promoting a strong global anti-counterfeit medicines campaign. He explained that the falsification of medicines is a growing threat to public health for all countries, all medicines and all people.

G. Bessaud emphasized that a study by the Pharmaceutical Security Institute documented a 34 percent increase in “false incidents” between 2014 and 2015. Once counterfeit medicines enter the supply chain, they endanger lives around the world, including in high-income countries. The growing market for online sales of counterfeit medicines magnifies the international threat.

Regulations

The European Medicines Agency’s Dr. Nathalie Bere gave an inspiring talk about regulations, the EMA and patient participation. Dr. Bere encouraged the leaders to have greater participation and collaboration with their respective regulatory agencies, offering examples so participants could learn how the EMA works and how important patient involvement is. She affirmed the importance of training leaders.

Health Technology Assessment

Dr. Hector Castro of Management Sciences for Health described the evolution of ETS. In particular, he noted how the Institutes of Health Technologies formed in recent years, the role they play for governments and how difficult it can be to incorporate a technology into a health system.

Dr. Castro explained in detail the work of decision-making in health and the difficulty that governments are having to ensure access. He said that there are very strict criteria that address issues of cost effectiveness, therapeutic efficacy and quality that determine access decisions, especially in chronic and catastrophic diseases. He also explained how the universal assurance model is not yet sufficiently well implemented in the region. There is still much work to be done, Dr. Castro argued, and patients have an important role in the advancement and improvement of health policies.

Advocacy & Education

Chase Martin presented educational resources created by the Global Alliance for Patient Access, explaining that advocacy leaders can take advantage of these without charge. Chase shared Spanish-language educational videos, articles, and position papers that GAfPA has created.

GAfPA is leading the Latin American Patient Academy. The group’s vision is that participating leaders can identify a specific problem to solve in their countries and have tools that make their work more effective, driving improvements in the health systems of their region.

Biosimilars

Durhane Wong Rieger of IAPO and Rare Diseases International addressed the group on biosimilars, the challenges in the region and how important it is to have informed decision-making on complex matters such as interchangeability and automatic substitution.

Biosimilars, which may reduce costs while maintaining high standards of safety, efficacy and quality, help expand treatment options for prescribers and patients to potentially improve overall health outcomes. Rieger discussed biosimilars’ therapeutic uses and how important it is to have strong pharmacovigilance programs. She also emphasized that patients should be educated and should understand their type of treatment and therapeutic options.

Rieger also presented the updated biosimilar toolkit recently launched by IAPO. She concluded her talk by affirming the importance of the systems being centered on the patient and making decisions prioritizing their needs.

The day’s program also featured:

• A video presentation by Jan Geissler, who created EUPATI
• Virtual greetings from those who could not be there in person, including Felicia Knaul of the Institute of Advanced Studies of the Americas at the University of Miami
• A presentation of a participant t’s guide and online toolkit for Latin American Patient Academy leaders, presented by Janeth Bouby, responsible for the academy’s virtual education and website, and GAfPA’s Eva Maria Ruiz de Castilla
• A presentation on collaborative efforts by GAfPA, IAPO and Alianza Latina, showing attendees the regional work that each organization performs. The talk also emphasized the strengths and opportunities in collaborating on common initiatives.

Following this first in-person meeting, participants will next work on a case study related to medication regulations. They will participate in two webinars to complete the academy’s Module 1.

The next in-person meeting of Latin American Patient Academy students will be in Lima, Peru on September 6-7, 2018.

[1] Head of Anti-counterfeiting coordination – Corporate Security SANOFI