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

FIFARMA Status Renewed as Non-State Actor in Official Relations with PAHO

FIFARMA Status Renewed as Non-State Actor in Official Relations with PAHO

The renewal was confirmed during the 162nd PAHO Executive Committee Session

Latin America, July 2018 – During the 162nd Session of the Executive Committee of the Pan American Health Organization (PAHO), the status of FIFARMA as a Non-State Actor in official relations with PAHO was renewed for a period of three years.

The declaration was formalized in the framework of resolution CE162.R9 dated June 21, 2018.

“We are very grateful to all the members of our Federation for their support during this process, and we are proud to continue working together with PAHO to promote policies that facilitate innovation and access to health in the region,” said Mr. Luis Villalba, FIFARMA General Director.

“FIFARMA currently represents 13 pharmaceutical laboratories and 9 pharmaceutical associations in Latin America,” added FIFARMA Operations and International Policy Director Juan Carlos Trujillo. “We serve as a bridge between medical and patient associations, private actors such as pharmaceutical laboratories, and governments. Renewing our status as Non-State Actor in official relations with PAHO confirms our role and motivates us to continue working to drive innovation and access to health for the entire population of Latin America.”

 

About FIFARMA:

FIFARMA is the Latin American Federation of Pharmaceutical Industry, a regional organization created in 1962, which represents 13 Research and Development Pharmaceutical Companies and 9 local Trade Associations across the Latin American region. FIFARMA members are involved in the research and development of innovative healthcare products and provide state-of-the-art healthcare solutions through a variety of products and services aimed to improve and save patients’ lives across the globe, placing patient safety as one of its main objectives. www.fifarma.org

 

Contacts:

María Alejandra Guzman

madeguzman@fifarma.org

Juan Carlos Trujillo

jctrujillo@fifarma.org

Commitment for Health

AMIIF and Participating Organizations Commit to Building a Stronger Healthcare System in Mexico

 

On June 28, 2018, three days before Mexico’s much anticipated elections, the Mexican Association of Pharmaceutical Research Industries (Asociación Mexicana de Industrias de Investigación Farmacéutica – AMIIF), together with more than thirty organizations from the private sector and civil society, developed and signed a working paper titled Commitment for Health. The document details six proposed solutions to improve the Mexican health system and is intended to serve as a work plan for the newly elected President of Mexico, his Cabinet, the new Federal Congress, States and Local Legislatures.

 

The key principles of the Commitment for Health working paper include:

 

  1. Investment: Increase investment in health as a percentage of GDP to the OECD average for 2018-2024. Currently, countries members of the OECD invest 9% in health, meanwhile Mexico invests 5.8%.
  2. Transparency: Make publicly visible how public resources are being used in the health sector.
  3. Cost-effective actions: Guarantee 100% vaccination coverage for children, as well as elderly and vulnerable populations.
  4. Prevention: Strengthen primary healthcare models in collaboration with the educational and productive sectors.
  5. Innovation: Ensure the supply of medicines and medical devices, and incorporate new technologies and pharmaceutical innovation in health.
  6. Optimize the planning of human resources required in the health sector.

 

AMIIF has always maintained that health is not only a right, but a social equalizer and a trigger for the economic growth and productivity of a country. By signing this commitment, AMIIF and other participating companies and organizations are reaffirming their belief that the health of a country is anchored to transparency and innovation and is a shared responsibility of civil society, governments, businesses and the pharmaceutical industry.

New Latin American Patient Academy (LAPA) Aims to Build Advocacy Capacity of Patients and Patient Organizations in the LATAM Region

The Latin American Patient Academy (LAPA) was launched in the context of the World Patient Congress held in Miami from May 24-26.  The Academy, 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.

The leaders of the four organizations enthusiastically led the launch of the program in Miami and the execution of its first module, a full day session attended by over 40 patient organizations from Latin America.

 Module 1 curricula focused on the participation of patients and patient organizations in the regulatory process and included a presentation by the head of patient engagement at the European Medicines Agency (EMA). Module 2 will focus on the role of patients and patient organizations in the Health Technology Assessment process, and will be followed by a third module on clinical trials, research, and how patients can learn about trials in their countries*.

Next Steps:

LAPA’s new website, mypatientacademy.org, is scheduled to launch soon and will enable participants to access training materials, advocacy tool kits, and connect with others in the LAPA network.

*Modules 2 and 3 will be organized as satellite meetings during the GAfPA Annual Meeting (to be held in Lima in September) and the Alianza Latina Annual Meeting (to be held in Buenos Aires in November). The Patient Academy also offers opportunities for virtual learning, including webinars and case studies, and participants who complete the program’s requirements will receive a diploma.

FIFARMA present at the 12th Annual Congress of Eyeforpharma LATAM

On May 17, Mr. Juan Carlos Trujillo, Director of Operations and International Policy of the Latin American Federation of the Pharmaceutical Industry (FIFARMA), moderated a panel of experts at the 12th Annual Congress of Eyeforpharma Latam.

The so called Multi-Stakeholder Panel was attended by four key players in the pharmaceutical industry: Eduardo Magallanes, Senior Vice President of Bayer Pharmaceuticals; Migdalia Denis, Founder and President of the Latin Society of Pulmonary Hypertension; Eva María Ruiz de Castilla, Director of GAfPA Latin America and Dr. Laura Suchil, Head of the Institutional Liaison Department of the National Cancer Institute of Mexico.

The topics addressed highlighted the importance of strengthening the links and collaboration among the main actors of health systems so that health care works and meets current needs.

“The governments of the region have a huge challenge ahead because they have to establish what are the priorities of investment with limited budgets,” appointed Juan Carlos Trujillo.

In addition, the executive urged to strengthen standards and promote good practices in the industry. “In Latin America, the main buyers and enablers of medicines are governments and we must develop policies and initiatives together to reach agreements that benefit patients”, he said.

2017 BCI Study Results Presented in Chile

On May 10th, results from the 2017 Biopharmaceutical Competitiveness and Investment (BCI) Survey were presented at a meeting organized by the Chamber of Pharmaceutical Innovation of Chile (CIF).

The BCI Survey, conducted by the international consulting firm Pugatch Consilium and commissioned by PhRMA and FIFARMA, evaluated 31 of the largest and most active pharmaceutical markets in the world, five of them in Latin America, to determine their relative attractiveness for biopharmaceutical investment. Chile was included in the survey for the first time in 2017, given the growing prominence of its healthcare industry in Latin America and among other emerging markets, including Singapore, Israel, Taiwan and Korea.

“The study reaffirms that the regulatory environment matters,” said Daniel Coriat, Director at Pugatch Consilium. “The index not only reveals which economies are more or less competitive in the biopharmaceutical sector, but also provides formulas to create attractive environments for foreign investment. The markets that have implemented economic and regulatory policies favorable to the pharmaceutical sector in the 5 areas covered by the BCI – such as Singapore, which has had significant progress in recent years, especially in the areas of regulatory and intellectual property protection and with a 87% score on the BCI index – have also experienced increased confidence among local business leaders, who as a result, are more prone to expand their operations, despite the small size of these economies.” 

Chile and Latin America in the Ranking

According to the 2017 BCI LATAM report, which evaluated 11 countries in the region, Chile ranked highest (with a score of 69.4%) in terms of attractiveness for biopharmaceutical investment in the region. According to the perception of executives interviewed, this is largely due to coherent economic and regulatory policies that are being implemented with a long-term vision of Chile becoming a center for pharmaceutical innovation.

Specifically, respondents ranked Chile highly in the following categories: environment for clinical studies, infrastructure of CROs (Contract Research Organizations), a simplified drug approval process, and a strong regulatory environment anchored to a regulatory body that has been designated as level 4 by PAHO/WHO and a robust registration framework for pharmaceutical products. However, respondents predict that the regulatory changes in the field of clinical trials resulting from the Ricarte Soto Law (continuity of treatment and responsibility without direct causality and in any event) will introduce significant uncertainty and may affect clinical research investment in the country.

“This ranking confirms Chile’s potential to develop into a world-class destination for  ​​biomedicine and the export of health services, contributing to productive diversification and the insertion of Chile into international knowledge-intensive activities and innovation,” said Jean-Jacques Duhart, executive vice president of CIF. “This is the path followed by many highly developed countries, and more recently, emerging countries such as Israel and Singapore. These countries have strengthened their services and industries linked to health, using them as an engine of dynamism and innovation and as a connector to other knowledge economies, while generating enormous benefits for the care of patients and the health of their populations.

CPP Requirements for Medicines Registration in the Region of the Americas. PANDRH’s CPP project.

The Pan-American Network for Drug Regulatory Harmonization’s (PANDRH) Steering Committee approved in December 2017 the project “Assessing the Certificate of Pharmaceutical Product (CPP) requirements for drug registration processes in the Region of the Americas towards more timely access to medicines and more convergent regulatory approaches“. The project is the first PANDRH’s initiative coordinated jointly by a National Regulatory Authority, CECMED/Cuba, and a regional pharmaceutical industry association, FIFARMA.

The execution of the project began in February 2018. In its first phase, an exhaustive mapping of the requirements and practices related to CPP in the region of the Americas will be developed. The resulting diagnosis aims at creating the base for a second phase, which has the objective of developing a structured discussion to identify opportunities for improvements in CPP regulatory requirements in the region.

The rollout of PADNRH’s CPP project coincides with the launching of the “Proposal for the revision of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce”, which will receive comments until May 15 and that can be found at:

The May Issue of the Drug Information Association’s  (DIA) digital magazine, the DIA Global Forum, which offers expert global and regional coverage of the discovery, development, regulation, surveillance, and marketing of healthcare products, including interviews with thought leaders and topical summaries from educational events, features an article on the CPP project co-authored by the project’s focal points in CECMED, Dra. Celeste Sánchez, and in FIFARMA, Jaime Oliveira. The article can be assessed here

We hope you enjoy the reading and join the CPP project’s community at PAHO’s platform PRAIS

The incorporation of innovative health technologies linked to the increase in life expectancy of Colombians

Life expectancy of Colombians increased by 5.9 years between 1990 and 2015 and, according to a study conducted by Professor Frank Lichtenberg of Columbia University, this increase is mainly due to improvements in access to quality technologies.

The investigation disclosed during the 60th anniversary event of the Association of Pharmaceutical Research and Development Laboratories (Afidro), at the Ágora Convention Center in Bogotá, also revealed that a 10 percent increase in the number of medicines launched generates a reduction of 3.9 percent in the potentially lost years of life of people under 55, after three years of entering the market.

In relation to diseases such as cancer, the researcher found that the number of years of potential life lost due to this disease, before 65 years of age, is inversely related to the number of drugs to treat cancer that have been released four years before.

 

In fact, according to Dr. Lichtenberg, 10 years of pharmaceutical innovation in the country reduced the number of years of life potentially lost by all natural causes before age 70 in 142,318 (years of life) in 2013.

But the impact of innovation is not limited to years of life, the researcher found that the estimated savings in spending on new drugs used per year of life in children under 70, derived from the use of drugs, is $ 4,734 in Colombia.

The new drugs launched in Colombia were very cost-effective. Evidence suggests that the entry of these drugs reduces other medical costs and increases productivity. Between 2006 and 2012, the launch of new medicines reduced the number of medical procedures in 2015 by 13.9%. The growth in the number of medical procedures performed has an inverse correlation with the growth in the number of medicines launched 2 to 3 years earlier, “explained Professor Lichtenberg, during the event.