Hosted by ISPOR CEE Consortium, Arabic and Africa Networks, an open meeting focusing on the Europe, the Middle East, and Africa (EMEA) regional health policy updates was held virtually at 9:30AM - 11:00AM, November 15, 2022. ISPOR CEO and Executive Director Nancy Berg delivered a welcome speech. ISPOR Global Member Engagement Director Robert Selby provided a brief report on 2022 ISPOR major activities in EMEA. Speakers from African Union Development Agency, Poland, and United Arab Emirates have been invited to present at this meeting.
This brief summarized a couple of reflections from two of the presenting experts.
Changes in the Polish Pricing and Reimbursement Law
Presented by: Marcin Czech, PhD, MD, MBA, President of ISPOR Poland Chapter, Head of Department of Pharmacoeconomics, Institute of Mother and Child, and Business School, Warsaw University of Technology, and Former Deputy Minister of Health, Warsaw, Poland
In Poland, there is a mixed healthcare system, with a strong dominance of public healthcare. Medicinal products may be financed or co-financed from public resources if they are recorded with their proprietary name on a special reimbursement list (medicinal products, medical devices and certain food for special nutritional purposes) or covered by a special Regulation of the Minister of Health (only certain categories of medical devices). The reimbursement list is updated every two months, following reimbursement decisions granted for each of the listed products, after special proceedings before the Minister of Health.
Since 2016 there is a special list of reimbursed medicines for elderly persons (the list 75+), entitling persons aged at least 75 years to obtain, under specific conditions, reimbursed medicines entirely free of charge.
The Polish regulations regarding the marketing authorisations are harmonized with the European Union laws on pharmaceuticals. Therefore, an authorisation to market a medicine in Poland may be granted following one of EU procedure (centralized, MRP, decentralised) or through the national procedure. Reimbursement is granted in an administrative decision, issued by the Minister of Health following special proceedings regulated in detail in the Act of Reimbursement of Medicinal Products, Food for Special Nutritional Purposes and Medical Devices, applied since 1 January 2012 (Reimbursement Act). The Reimbursement Act is completed by numerous regulations. The reimbursement decision determines detailed terms of reimbursement and a fixed price of the reimbursed medicine. Other terms of reimbursement include a channel in which the medicine is reimbursed (pharmacy or hospital), co-payment level (only pharmacy medicines), the limit group in which the reimbursed medicine is included (all medicines in such a group have the same financing limit.
An amendment of the Act of Reimbursement is currently processed in the Polish Parliament including numerous changes that, if accepted, would re-define the pharmaceutical decision-making landscape in Poland.
In addition, the recent regulation on Medical Fund in its pharmaceutical part is devoted to rare diseases, oncology and recently vaccines (only financing). The Medical Fund guarantees an additional funding for innovations, defines “health technology of a high level of innovativeness”, “health technology of a high clinical value”, gives new competencies HTA Agency (e.g. RWE), and strengthens Economic Committee role in the system. The selection criteria for the health technology of a high level of innovativeness are the following:
- Therapeutic intervention power
- Quality of scientific evidence
- Unmet medical need
- Target population
- State health priorities
The first medicines selected through this new pathway have been already financed from public sources.
There are many challenges ahead in the Polish reimbursement system including cell and gene therapies financing. New Value Assessment Frameworks by ISPOR can broaden a future perspective and serve as a part of a solution.
Updates on the African Medicines Regulatory Harmonization (AMRH) & African Medicines Agency (AMA)
Presented by: Margareth Ndomondo-Sigonda, Head of Health Programs, African Union Development Agency -New Partnership for Africa’s Development (AUDA-NEPAD)
The AMRH Initiative started in 2009 as a partnership framework for strengthening the capacity of national regulatory agencies (NRAs) to safeguard public health against use of poor quality, unsafe and infective medical products circulating in countries across the continent. This partnership is between NRAs across the continent in collaboration with regional economic communities (RECs), the AUDA-NEPAD, the African Union Commission (AUC), the Pan African Parliament (PAP), the World Health Organization (WHO), the World Bank, the Bill and Melinda Gates Foundation, the Foreign, Commonwealth & Development Office (FCDO), formerly, UK Agency for International Development (DFID), just to mention a few. The AMRH is implemented as part of the African Union (AU) Policy Framework – The Pharmaceutical Manufacturing Plan for Africa (PMPA) to improve access to quality, safe and efficacious medical products to the African populations.
Given the enormous regulatory challenges faced by a majority of AU member states, the partners agreed to take a stepwise approach by starting with harmonization of requirements for registration of generic medicines while slowly expanding the scope to cover other regulatory functions such as clinical trials and ethics oversight, post marketing surveillance including safety monitoring, and good manufacturing practice (GMP) inspections. Joint regional dossier assessments, joint inspections of manufacturing sites to ensure compliance with good GMP standards, work sharing among NRAs through pooling of resources, and subsequently streamlined decision-making processes at country level was part of the program. The product category was extended to new chemical entities (NCEs), vaccines, medical devices, and diagnostics. The harmonizing and streamlining technical requirements for product registration would lead to reduced registration timeline, contributing to product access and creating a platform to build African regulatory capacity by region. The program is implemented through five African Union (AU) recognized RECs namely the East African Community (EAC), Southern African Development Community (SADC), Economic Community of West African States (ECOWAS), Intergovernmental Authority for development (IGAD), and the economic community of Central African States (ECCAS).
The African Medicines Agency (AMA) Treaty came into force on the 5th of November 2021, following the deposit of the 15th instrument of ratification with the AU Commission and now 23 countries have ratified the Treaty. AMA is being established as an offshoot of the AMRH governance structure to strengthen regulatory systems continent wide through harmonization of technical standards and processes, in alignment with international standards [1]. AMA will coordinate the ongoing regulatory harmonization initiatives including joint assessments of medical products, joint inspections of manufacturing sites, safety monitoring of medical products. AMA will support countries to assess complex molecules such as vaccines and will facilitate authorization of products during emergencies. It will provide scientific and regulatory advice in support of local pharma industry development including the Partnerships for African Vaccine Manufacturing (PAVM) Framework and also facilitate removal of unnecessary technical barriers to trade in support of African Continental Free Trade Area (AfCFTA).
Reference
[1]The AU Executive Council decision of January 2015 recognizes the AMRH as the foundation for establishment the AMA. The AMRH Governance structure constitutes the African Medicines Regulators (AMRC) Assembly, the Steering Committee, the Partnership Platform, the Technical Committees, and the Secretariat
To view the full meeting presentations, please visit the
ISPOR Global Networks Online Community Library page.