FIFARMA Local Associations Meeting 2019

FIFARMA’s annual local associations meeting was held on January 29th and 30th, 2019 in Santiago, Chile.

 

Directors from all member associations had the opportunity to be involved in strategic discussions focused on improving and promoting healthcare for the Latin American population, and learning about the objectives of each Association in the region, which help guide and refine FIFARMA’s regional priorities for 2019. The discussions were led by Luis Villalba, Executive Director of FIFARMA and Juan Carlos Trujillo, Director of Operations and International Policy of FIFARMA. Additionally, Carl Meacham, Associate Vice President Latam of PhRMA, contributed his association’s perspective and priorities for Latin America in 2019.

 

On the second day, the meeting was attended by two guest speakers: Mr. Rony Lenz, representing the Institute of Public Health of Andres Bello University, and former president of the Chilean Chapter of the International Society for Pharmacoeconomics and Outcome Research (ISPOR), and Mr. Javier Picó, of LifeSciences Consultants Mexico. Both experts participated in a panel moderated by Jean Jacques Duhart, Vice President of CIF, and Cristóbal Thompson, Executive Director of AMIIF, which aimed to inform FIFARMA members and partner organizations about new perspectives to foster public spending efficiencies on healthcare systems.

 

The local associations meeting was conducive to sharing experiences and objectives, which clearly showed common themes and goals for improving healthcare and access in the region, considering the different local contexts and shaping FIFARMA’s agenda and support priorities for 2019.

 

Author: FIFARMA.

CPP project’s preliminary outcomes and work process in the IX PANDRH Conference, El Salvador

The preliminary outcomes of the mapping survey of PANDRH’s CPP project were presented in the IX PANDRH Conference, held in El Salvador from 24 to 26 of October, 2018. The objectives and phases of the project, as well as the strategy of the project’s coordinators, CECMED/Cuba and FIFARMA, to assure a significant participation of National Regulatory Authorities (NRA) and industry associations in the Region of the Americas were also shared with the participants of the Conference.

 

The presentation was held in the last day of this important meeting for the Focal Point for the Industry, Dr. Jaime Oliveira, in the Panel “Regulating drugs supply chain and its impact on health systems”. The Panel was moderated by Dr. Murilo Freitas from the Pan-American Health Organization and Dr. Cynthia Luwis, from the Jamaican Health Authority.

 

The audience of the Panel had the opportunity to know the project’s preliminary outcomes and to understand the steps taken by the project’s coordinators so far to obtain detailed information about CPP-related requirements and practices adopted in the Region of the Americas.

 

The strategy adopted by CECMED and FIFARMA to promote the project among relevant stakeholders and to encourage NRA & industry associations to participate of the mapping survey, has resulted in a solid database that will allow for a qualified discussion on the current CPP’s requirements and practices in the Region in the next phases of the project.

 

The figure below shows information about the participation in the CPP’s diagnostic survey until the date of the Conference.

CECMED and FIFARMA are currently working with the information of the database to prepare the CPP mapping report, which will be delivered in the beginning of 2019 to PANDRH’ Steering Committee.

 

Interested parties may follow the project, consult relevant documentation, including the presentation made in PANDRH Conference, and know the CPP project’s agenda by registering at PAHO’s Regional Platform on Access and Innovation for Health Technologies (PRAIS) and joining PANDRH’s CPP project Community of Practice (http://prais.paho.org/stage/#).

FIFARMA at ISPOR: Highlights on access to innovative medicines in Chile

ISPOR Chile organized an international seminar focusing on “Health Reform, Access and Financing of Medicines” at the University of San Sebastian, on November 28th, 2018.

During this event, results from the study “Analysis of Access to Innovative Medicines in Chile compared to other OECD countries“, were presented by IQVIA at the request of FIFARMA and CIF. The study compared registration and timing of reimbursement for 247 innovative molecules in Chile vs. the same parameters for twenty-two (22) OECD member countries.

According to the results, only 5 out of the 117 molecules registered in Chile have been included under the Ricarte Soto Law or are part of the GES pathologies, which means that less than 6% of the molecules registered in Chile are included in any of the broad reimbursement mechanisms available in the country. This percentage is far from the 70% average rate shown for the other OECD member countries.

In order to highlight relevant information from the study, Daniella Rodríguez, Engagement Manager of IQVIA Colombia said: “If we look at the data analyzed, we notice that Chile has a very good average time of registration of innovative medicines, with an average of only 7 months, the fastest of the countries studied, but on the other hand, Chile shows the longest delays in including these medicines into the coverage and public financing systems”.

Chile ranks 18th, among countries included in the study, with over 18 months of delay between registration and reimbursement, which is very distant from the 13-month averaged by other members.

In addition, Jean-Jacques Duhart, Executive Vice President of CIF, added: “The results of the study show that Chilean patients have much lower financial coverage from public health insurance, and therefore less access to innovative medicines and treatments than patients from the other OECD countries. Even Mexico, which has a lower GDP per capita, offers patients health coverage 7 times higher than Chile”.

Sharing the innovative pharmaceutical industry’s perspective, Luis Villalba, Executive Director of FIFARMA, indicated that: “Being able to develop and understand the data of a study as relevant as the one we present today, allows us to measure the importance of universal access to health. At FIFARMA we support all regional initiatives which promote innovation, access to health and patients´ education to achieve a comprehensive and transparent health system “.

 

Author: Juan Carlos Trujillo de Hart   FIFARMA International Policy and Operations Director

FIFARMA at the VI ALIBER Meeting

The Ibero-American Alliance of Rare Diseases (ALIBER) celebrated its VI Meeting in the city of Bogota, Colombia, from November 20th to 22nd.

 

The VI ALIBER Meeting, a space for academia and updates, aimed at raising awareness about the importance of rare diseases in Ibero-America. The meeting was attended by leading specialists within the healthcare industry including representatives of the scientific and governmental fields, patient networks, and pharmaceutical companies.

 

FIFARMA, one of the organizations present at the event, was represented by Juan Carlos Trujillo, Director of Operations and International Policy of the Federation. The executive participated in the panel called Evaluation of Technologies in Colombia, where he spoke about the participation of patient network organizations in the evaluation of health technologies:

 

 “In patient-centered health policies, the participation of patient organizations in the evaluation of health technologies is of vital importance,” said the expert.

 

The Ibero-American Alliance for Rare Diseases (ALIBER) is a non-profit organization founded in 2013 by 11 patient organizations, which has consolidated as a coalition that integrates and empowers different associations of people affected by rare diseases in Latin America.

 

ALIBER represents a total of 42 million people affected by rare diseases through over 500 organizations brought together by its 47 partners in 13 countries.

 

FIFARMA, committed to improve people’s access to health and patient empowerment, joins the initiatives of the region that promote innovation, universal access to health and the training of patients towards a comprehensive and transparent health system.

 

Author: Maria Alejandra de Guzman – FIFARMA Communications Manager

LAPA implemented its Third Module

The third module of the Latin American Patient Academy (LAPA) took place in the city of Sao Paulo, Brazil, on November 8th.

LAPA promotes training in advocacy and public health policies in patient groups all over the region, and has the prestigious collaboration of academic experts. The initiative has the support of FIFARMA and is a program designed by the Global Alliance for Patient Access (GafPA), the International Alliance of Patiens’ Organizations (IAPO), and the Latin Alliance.

Throughout 2018, LAPA offered Modules 1 and 2, accompanied by webinars and case studies. At the end of the year, the program was closed with Module 3, whose main topic was patient’s participation in the processes of Research and Development of new medicines.

The most outstanding speakers included the Brazilian Society of Professionals in Clinical Research’s President Dr. Greyce Lousana, the University of Sao Paulo’s Center for Research in Health Law Scientific Co-Director Dr. Fernando Aith, and Dr. Michelle Arguelles and Dr. Luther Clarck from MSD, among others.

The event, which was attended by several groups of patients from Latin America, concluded the one-year cycle of technical and academic learning aimed at promoting the development of patient networks in the region.

 

Author: MariaAlejandra De Guzman  – FIFARMA Communications Manager

Pharmacovigilance in Latin America: Current situation and challenges

FIFARMA sponsored the 5th Symposium of the ISoP Latin America Chapter. The event was held in the School of Public Health, Sao Paulo University, Brazil, on 29th and 30th October 2018.

 

The objective of the meeting was to analyze the current scenario and future challenges of pharmacovigilance in Latin America. In addition, the symposium was attended by notable panelists from both scientific and governmental fields and by patient associations representatives.

 

Dr. Fernanda Simioni Gasparoto, from ANVISA’s Pharmacovigilance Unit, presented an update of the Risk Management Plan in Brazil. Then, the award-winning journalist Natalia Cuminale, from Veja Magazine, led the panel on pharmacovigilance from the patient’s point of view. The panel was comprised by Dr. Anthony Wong and Cristina Andrusaitis from CEATOX, Dr. Ricardo García from ClapBIO, Dr. Luis Alesso representing ISoP, and journalist Priscilla Torres, coordinator of patient associations GRUPAR / EncontrAR and author of the blog Artitre Reumatoide (Brazil).

 

Since 2009, the official year of its creation, the ISoP Latin America Chapter has had outstanding new members in the region: ANMAT, ANVISA, Society of Pharmacovigilance of Venezuela, Argentine Society of Pharmacovigilance and the University of Buenos Aires, among others.

 

Author: Maria Alejandra De Guzman – Communications Manager at FIFARMA

FIFARMA presents at the IX Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH)

The IX Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH) was held in El Salvador from October 24th-26th, 2018. The meeting, entitled “Contributions of regulatory harmonization in the achievement of health for all,” commemorated 20 years of the PANDRH  Network (Pan American Network on Drug Regulatory Harmonization) and 40 years of the Alma-Ata Declaration of 1978. The Network is a joint initiative of the National Regulatory Authorities of the Region and the Pan American Health Organization (PAHO) to support the harmonization of pharmaceutical regulation in the Americas.

 

The meeting was organized by the National Drug Directorate of El Salvador, in coordination with PAHO, and was attended by more than 300 healthcare leaders from 35 countries in Latin America. Following previous conferences in Ottawa and Mexico, this year’s event continued the discussion on strengthening of regulatory systems in the region.

 

FIFARMA promotes and supports the work of the PANDRH Network.  In fact, in December 2017, the Executive Committee of the PANDRH Network approved the first joint initiative between PANDRH, FIFARMA and Cuba’s National Regulatory Authority (CECMED), titled “Evaluation of the Requirements of the Pharmaceutical Product Certificate (PPC) for registration processes in the Region of the Americas, towards more timely access to medicines and more convergent regulatory approaches.”

 

During the IX PANDRH Conference, four prominent panelists representing FIFARMA presented and provided highly appreciated contributions and updates:

 

  • Plenary Session 4: Transparency and information for decision making

Cristina Mota Pina, Director, Scientific Regulatory Policy and Intelligence – Latin America AbbVie, presented on transparency, stakeholders responsibilities and participation in regulatory processes:

“…Because at some point in life we are all patients, we must guarantee transparency in everything we do.”

 

  • Plenary Session 5: Improvement of regulatory capacities

Thomas Schreitmueller, Global Head Regulatory Policy at F. Hoffmann – La Roche AG, Switzerland, shared the industry perspective on strengthening the regulatory system in the region:

“..The increasing speed of scientific progress, our understanding on the underlying causalities of diseases and as a result the availability of innovative healthcare solutions make the need for strong and efficient regulatory systems more urgent than ever before”

 

  • Plenary Session 6: The use of information in regulatory convergence

Jaime Oliveira, Head Regulatory Policy and Intelligence at Bayer Latin America, provided an update on the PANDRH Project (evaluation of CPP requirements for the registration of medicines):

“…The CPP project has reached a steady pace and gained great visibility in the Region and also globally through the WHO. This is the result of the work of the project’s coordinators, CECMED/Cuba and FIFARMA, and also of the engagement of National Regulatory Authorities and industry’s trade associations in the region of the Americas. We expect important outcomes from this project and that it becomes a concrete example that regulators and industry can work together to reach convergent objectives”.

 

  • Plenary Session 7: Regulatory approaches based on risk in all regulatory functions

Denise Bonamici, Head of Regulatory Science & Policy – Latin America at Sanofi, presented topics on risk management for regulatory purposes:

“…We see encouraging examples of trust, shared work and efficient use of resources in our region.”

 

Authors: Thomas Schreitmueller, Global Head Regulatory Policy at F. Hoffmann – La Roche AG, Switzerland and María Alejandra De Guzman – FIFARMA Communications Manager

FIFARMA Holds 2018 Regional Meeting

FIFARMA held its 2018 Annual Regional Meeting on May 23 and 24 in Washington DC (US).

Member companies and associations met with the objective of analyzing and reviewing the strategies and activities implemented during the previous year and to develop an action plan for the Federation for 2019.

The first day of the regional meeting began with a strategic planning session with Vice Presidents from across the region, followed by the presentation of FIFARMA’S organizational objectives by FIFARMA’s Director General Luis Villalba, and Director of Operations and International Policy Juan Carlos Trujillo. FIFARMA’s session was followed by several presentations by leading experts, including Carlos Gutierrez (Chair of the Albright Stonebridge Group and former US Secretary of Commerce, 2005-2009), who spoke about the challenges and opportunities of current public policies, as well as Catherine Mellor (Executive Director, Global Health Initiative, ‎U.S. Chamber of Commerce) on the role of private actors in regional politics, and Sydney Clark (Senior Vice President, IQVIA) on the dynamics of the Latin America pharmaceutical market and the impact of digital communications in the pharmaceutical industry. Industry priorities were reviewed over a working lunch, and the day concluded with a  FIFARMA Executive Committee meeting and a presentation of LATAM IP trends by PhRMA’s Chris Moore.

On the morning of the second day of the meeting, local associations had the opportunity to discuss their activities and priorities with representatives from PhRMA, BIO and FIFARMA. FIFARMA’s regional communications strategy was presented by María Alejandra De Guzman (Communications Manager, FIFARMA) and Harold Hamana (Managing Partner, Knight + Pawn), and followed by an update on OECD from PhRMA’s Carl Meacham. FIFARMA working groups met in the afternoon to discuss key strategic themes.

In summary, the meeting was successful in bringing together pharmaceutical companies, industry organizations and local associations to promote collaboration and alignment among FIFARMA members to help finalize and activate the Federation’s 2019 strategic plan.

 

Author: FIFARMA

FIFARMA and AFIDRO participate in The Economist’s ‘War On Cancer LATAM’ Event

Last Tuesday, September 18th, the Economist held the “War On Cancer LATAM: Shared Struggles, Collective Success” conference in Bogotá, Colombia. The event was well attended by  leaders of the pharmaceutical industry in Latin America, including pharmaceutical companies executives, public sector representatives (State and National Government officials) and patient organizations.

 

FIFARMA and AFIDRO were main sponsors of the event and actively participated in promoting the dialogue between the different actors. Both institutions had their own stand (booth) at the event, and Mr. Gustavo Morales, Executive President of Afidro, participated in a panel discussion on the importance of engaging finance ministries.

During his presentation, Morales noted: “In Colombia, we choose private companies to manage health, but with public restrictions, and we have not benefited from competition from the private sector.” He also added: “We must agree on health as a fundamental right in Colombia.”

In a similar light, Fernando Fon Mendez, Medical and Regulatory Affairs Director of AMIIF, a member association of FIFARMA, spoke about the importance of cross-sector engagement in Mexico: “Mexico has noticed that it is important to involve different actors, not only health actors, who  allow the creation of an interdisciplinary network to improve the health system.”

During the meeting, the results of a major study on lung cancer in Latin America were also disseminated.

The study, called ‘Lung Cancer in Latin America: Time to Stop Looking Away,’ was developed by The Economist Intelligence Unit with the support of Roche Laboratories, and analyzed data from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Paraguay, Peru and Uruguay. Their findings indicate that lung cancer has resulted in more than 60,000 deaths each year in these countries, with an annual cost of over US$ 1,600 million.

During the War On Cancer Conference, we saw prominent panelists from the scientific world, pharmaceutical companies, the public sector and from patient organizations united under a common goal: to promote access to health and the possibility of better treatments made available to the entire population.

At the end of the event, Juan Carlos Trujillo, FIFARMA’s Director of Operations and International Policy, concluded: “We are proud to support this type of event where dialogue is facilitated and promoted between the different key players that shape the biopharmaceutical industry.” He added: “Gathering in spaces, such as War On Cancer, where scientific and social conversations converge with the regulatory frameworks of each country in the region, is important to facilitate decision-making and the design of public policies in the biopharmaceutical industry.”

 

Autor: María Alejandra De Guzman – FIFARMA Communications Manager

Latin American Patient Academy (LAPA) held its second session in Lima to continue to build the advocacy capacity of patients and patient organizations in Latin America

The Latin American Patient Academy (LAPA) held its second session during the 3rdAnnual Latin American Summit for the Promotion of Biological and Biosimilar Policies of GAfPAfrom September 6-7 in Lima, Peru.

In line with the goals of the Summit,the objective of LAPA’s second session was to highlight the important role of patients and patient organizations in the Health Technology Assessment process.28 leaders from Latin American patient organizations received training in the evaluation of health technologies.

The meeting was guided and executed by representatives from the pharmaceutical industry in Latin America.

LAPA, an advocacy capacity building program, is a joint program of the Global Alliance for Patient Access (GAfPA), the International Association of Patient Organizations (IAPO), and Alianza Latina, with academic support from the Department of Adult Virtual Education of the Catholic University of Peru, and financial support from 13 FIFARMA member pharmaceutical companies. 

 

Autor: María Alejandra De Guzman –FIFARMA Communications Manager