Legislative and regulatory aspects

Introduction

The International Pharmaceutical Forum (IPF) is an annual meeting for pharmacists and other health professionals to discuss issues relating to the development of the pharmaceutical sector. The meeting is organised under the aegis of the Inter-Order of Pharmacists of Africa (IOPA), the Intersyndical of Pharmacists of Africa (ISPHARMA), the Association of National Pharmaceutical Regulatory Agencies (AANRP) or the Directorates of Pharmacy and Medicines (DPM), and the Association of Central Purchasing Agencies for Essential Medicines (ACAME).

Launched by the African Council of Ministers of Health in Yaoundé in 1999, the first Pharmaceutical Forum was held in Benin in 2000. This year, Togo is hosting the 23rd edition of the FPI, the main theme of which is “Universal access to healthcare: challenges, issues and prospects for the pharmaceutical sector”. The forum, scheduled to take place from 3 to 6 July 2024, will address a number of sub-themes, including: Legislative and regulatory aspects. Pharmaceutical legislation and regulation must act as an authority supporting pharmacists in the implementation of their roles and responsibilities with the aim of fully promoting universal access to healthcare.

Context and justification

Pharmaceutical legislation/regulation is a normative act designed to provide a framework for the practice of the pharmaceutical profession. For any practice, pharmacists need to know their rights and duties. As pharmacists are the guarantors of the proper use and safety of medicines, they are an essential link in the universal access to care (UAC) system. The aim of UHC is to ensure that all patients have rapid and equitable access to safe, effective and affordable medicines. The uneven distribution of private pharmacies in some countries, combined with a shortage of hospital pharmacists, is leading to the “guarantor of medicines” pharmacist being replaced by less qualified people, sometimes in contravention of legislation and regulations. Apart from this aspect, the dispensing of medicines is subject to legislation.

Pharmaceutical regulations take into account the distribution and use of medicines, including distribution channels, prescription procedures and conditions of access to treatment.

Within the framework of the AUS, it would be advisable to clarify these regulations once again and to find appropriate solutions for better compliance with pharmaceutical regulatory provisions in areas where there are no pharmacies or pharmacists.

Objectives

General objective

To describe the legislative and regulatory requirements for improved access to medicines.

Specific objectives

Discussions during these days should make it possible to :

  • Discuss the updating of countries’ lists of essential medicines;
  • Explain existing shortcomings in the application of texts;
  • Propose texts to govern the delegation of powers to dispensing pharmacies and hospitalpharmacists in remote areas;
  • Explain the importance of exemption from customs duties in supply systems;
  • Share experiences of access to medicines in health insurance systems.

Methodology

This sub-theme will be addressed in the form of a round table. The panellists will share their experiences and tell us about the various laws that will enable us to achieve our objectives

Results

At the end of the work on this theme :

  • The list of essential medicines will be updated;
  • Solutions are proposed for better supervision of pharmaceutical activity in deserted areas in dispensaries and hospital pharmacies;
  • Proposals for reducing customs duties have been drawn up;
  • A course of action is proposed for the proper application of pharmaceutical legislation and regulations;
  • Country experiences were shared on the AUS.