III ISPOR Congress CAC Chapter

The ISPOR Chapter of Central America and the Caribbean (CAC) held its III Congress in Santo Domingo, Dominican Republic at the Intercontinental Hotel on March 14th and 15th, 2019.

Discussions at the forum focused on the tools offered to decision-makers, considering perspectives such as: efficiency, value for money, and patient centricity.

FIFARMA was represented in this event by Dr. Diego Guarin, Senior Director Evidence and Value Development & HTA Strategy Latin America at EMD Serono and Co-Chair of FIFARMA’s Value and Access to Innovation Working Group. Dr. Guarin participated in the “Claves para la transformación de la sostenibilidad de los sistemas de salud” panel hosted by the Central American Pharmaceutical Laboratories Federation (FEDEFARMA).

According to Dr Guarin: “PAHO’s strategy for Universal Access to Health, recognized financing as a necessary, although not sufficient, condition to reduce inequities and increase the financial protection of the population”.  He continued explaining that “the strategic line of PAHO has 3 priorities:

  • Provide financial protection by eliminating direct payment, which represents a barrier to access
  • Increase public financing of healthcare expenditure to the reference level of 6% of GDP, which implies a commitment by society as a whole to increase the fiscal space reserved for health in terms of new public sources of financing
  • Improve the efficiency of the health system by specifically impacting its financing and organization, aligning payment mechanisms with the objectives of the health system and rationalizing the introduction of new medicines and technologies”.

Even though sustainability in Healthcare Systems represents a challenge in a complex scenario, Dr. Guarin described alternative solutions to empower efficiency and financing.

Risk- Sharing Agreements, added Dr. Guarin quoting an extract by the HTAi Policy Forum 2010, are: “agreements between the producer and a payer/provider to allow access to a health technology subject to specific conditions. These agreements can use a variety of mechanisms to reduce uncertainty about the performance of technology, its adoption or to maximize its effective use or limit its financial impact”.

“At FIFARMA we strongly believe in the value of innovation. Despite the challenging healthcare financing context, it is possible to go beyond budget barriers and stablish innovative agreements which contribute to a sustainable healthcare system all over the region”, highlighted Juan Carlos Trujillo, International Policy and Operations Director at FIFARMA.

Authors:

Diego GuarinEMD Serono Senior Director Evidence and Value Development & HTA Strategy Latin America

Co-Chair of FIFARMA’s Value and Access to Innovation Working

María Alejandra de GuzmanFIFARMA Communications Manager

FIFARMA at CMC Strategy Forum Latin America 2019: The importance of harmonized guidelines and work sharing

The CMC Strategy Forum Latin America 2019 took place in Brazil, on March 12th-13th. The event focused on regulatory update and featured an opening session including presentations from regional regulators, as well as the FDA.

FIFARMA was represented by Dr. Thomas Schreitmueller, Global Lead for Regulatory Policy at Roche and FIFARMA’s Regulatory & Biologics Working Group Co-Chair.

Dr. Schreitmueller participated in the session around life cycle management (LCM) for biotherapeutic product pitchings: Why We Need Effective LCM Regulatory Systems Now and Even More in the Future, which delivered regulatory key considerations on post-approval changes for pharmaceutical products facilitating global regulatory convergence.

Dr. Schreitmueller affirmed that: “Innovative drug development approaches require innovative and strong regulatory systems and procedures. National regulatory agencies (NRAs) are encouraged to take into consideration and implement available internationally harmonized guidelines on that subject, for example from the World Health Organization (WHO) and the International Council of Harmonization (ICH) and thus ensuring global alignment and regulatory convergence”.

“The WHO post approval change guidance for biotherapeutic products (BTPs) has all features that will significantly facilitate the work related to product life-cycle both at industry and NRAs and should be implemented by regulatory agencies across LATAM”.

He further outlined “FIFARMA is fully aligned with the Pan American Network for Drug Regulatory Harmonization (PANDRH) and the recommendations coming from their IX Conference that we need to push a change in the regulatory paradigm, building regulatory systems solid, efficient and transparent based on concepts such as reliance, worksharing and international collaboration which also should be considered in the context of efficient regulatory LCM approaches”.

Dr Schreitmueller finished his talk by citing Dr Tedros Adhanom Ghebreyesus, WHO Director-General “We need innovation and disruption – not just for developing new products, but for developing new ways of delivering those products and new ways of working together to deliver results.”

The CMC Strategy Forum Latin America 2019 offered a successful space for panel discussions designed to stimulate exchange of ideas and information around regulations and regulatory processes related to biotherapeutic products.

Authors: Thomas SchreitmuellerRoche Global Lead for Regulatory Policy

Co-Chair of FIFARMA’s Regulatory & Biologics Working Group

María Alejandra De Guzman – FIFARMA Communications Manager

FIFARMA at LARC 2019

The Drug Information Association (DIA) recently sponsored “Latin America Regulatory Conference 2019” in Miami, US on February 21st – 22nd.

 

The symposium offered engaging panels led by health influencers discussing the advancement and implementation of regulatory convergence initiatives in Latin America.

 

FIFARMA was represented in this event by Dr. Thomas Schreitmueller, Global Lead for Regulatory Policy at Roche and FIFARMA’s Regulatory & Biologics Working Group Co-Chair. He participated in the session entitled Lifecycle Management – How to Cope with the Increasing Regulatory Demand on Post-Approval Changes for Faster Medicines Access. This session covered the most recent regulatory updates on post-approval changes for pharmaceutical products facilitating global regulatory convergence.

 

According to Thomas Schreitmueller: “The regulatory management of post-approval changes for pharmaceutical products currently is a highly complex, redundant and inefficient process on a global basis. National regulatory agencies (NRAs) are encouraged to take into consideration and implement available internationally harmonized guidelines on that subject e.g. from the World Health Organization (WHO) and the International Council of Harmonization (ICH) and thus ensuring global alignment and regulatory convergence. At the same time processes should be established that will allow a NRA to take into account the assessment work already done by another NRA with recognized expertise. These reliance processes will reduce redundancies significantly e.g. currently a product change incl. the same justification and data may be assessed by all NRAs in the world coming to the same conclusion. Having globally implemented harmonized regulatory guidance and having established reliance based, regulatory processes will ensure the availability of any medicine with the most up-to-date quality at the same time all over the world for the patients that need it. In that sense FIFARMA is fully aligned with the Pan American Network for Drug Regulatory Harmonization (PANDRH) and the recommendations coming from their IX Conference that we need to foster a change in the regulatory paradigm, building regulatory systems solid, efficient and transparent based on concepts such as reliance, worksharing and international collaboration. Let’s start working on it, together, now!”. 

 

The Latin America Regulatory Conference was attended by global regulators, industry, and academia to identify opportunities for regulatory harmonization to reduce lifecycle management complexity for patient’s benefit.

 

“At FIFARMA we strive to support events such as the Latin America Regulatory Conference, organized by DIA, which highlight and develop intelligence about key topics for the biopharmaceutical industry in our region, such as regulatory harmonization and pharmacovigilance”, said Juan Carlos Trujillo, International Policy and Operations Director at FIFARMA.

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