Integrating southern Mediterranean medication markets
One of these propositions is to “set up increased regulation of the medication market encouraging greater convergence, even integration, in the Maghreb” and to encourage collaboration between these countries. Examples of concrete action to move towards a more integrated medicine market in the Maghreb include: greater convergence of marketing authorization application (MAA) procedures, a common scientific committee to assess MAA requests, and policies to support complementary national production, etc.
Given this background, IPEMED aims to produce an overview of the medication market in three Maghreb countries (Morocco, Algeria and Tunisia), highlight existing complementary features and identify the structural elements that would lead to greater integration in the Maghreb.
In Europe, a standardisation of procedures started, since 1995, with the creation of the European Medicines Agency (EMA), an EU body in charge of assessing and supervising medicines and the implementation of the centralised procedure (the EMA evaluates and decides to grant the marketing authorization that applies to all European countries) and with the creation of mutual recognition (when a medicine already has a marketing authorisation in a member country and that it is destined to be marketed in one or several other Member States, the latter can be asked to recognised the marketing authorization granted by the reference Member State chosen by the company). In 2005, a decentralised procedure was also implemented. This procedure, quicker and less constraining than others, is used when a medicine does not yet have a marketing authorisation (the file is submitted at the same time in all concerned countries, the reference country chosen by the company carries out the evaluation, if the reference country grants authorisation, it is granted by all other Member States simultaneously).
Another example to mention in terms of standardization of medicines registration procedures at a regional scale is that of the Member States of the West African Economic and Monetary Union (WAEMU) that could serve as a model to implement a standardization system to regulate registrations and quality control. The Regional Economic Communities (RECs) offer the best institutional framework to promote these reforms. The reform started by WAEMU relies on three complementary devices led by regulatory texts:
- a centralized MA device organized around a Committee for Veterinary Medicinal Products (CVMP) in charge of MA requests;
- a unique device of quality control via a network of reliable laboratories from the WAEMU Member States;
- a regulatory device, presented by the WAEMU Veterinary Committee, a consultation body, in charge of coordinating regulatory actions.
The situation of pharmaceutical markets greatly differs from one North African country to another (Morocco manufactures a lot of pharmaceuticals and covers nearly 70% of its national needs, Algeria and Tunisia find themselves at inferior levels, with 40 or even 50% and Tunisia has a monopoly of pharmaceutical importation). It cannot be compared to that of European countries in the early 1990’s. However, similarities exist between North African countries: willingness to develop medicines production and especially of generic ones, multiplicity of small-size non-competitive manufacturing units, supply issues especially in the public sector, etc. A greater integration of these markets can thus be contemplated.
The advantages of a common MA procedure would be significant:
- promoting better access to medicines for populations;
- supporting the emergence of a high-level scientific and technical community (“regulatory scientific community”) via the sharing of knowledge and expertise in terms of medicines assessment and regulation between the concerned countries;
- giving more importance to the concerned countries in their international negotiations;
- Developing the local pharmaceutical industry by making access to pharmaceutical markets easier at the North African scale (to benefit from economies of scale);
- Reducing delivery times and the procedure costs.
Recommendations regarding the integration via medicines joint purchase
- Reactivating the North African Committee for medicines joint purchase and giving it the responsibility to buy a list of products defined by joint agreement (UMA);
- Drawing up a list of the common needs regarding pharmaceutical products in North African countries while awaiting for the creation of a common list of basic medicines and the updating of the North African joint purchase convention (UMA);
- Implementing a permanent commission of bid preparation for medicines joint purchases;
- Applying to pharmaceuticals and medical items manufactured in North Africa the principle of national treatment regarding the taxes demanded in the importer country.
Recommendations regarding integration via MA
- Organizing workshops, meetings and symposiums on the standardization procedures of medicines registration and control;
- Making easier the cooperation between national laboratories of pharmaceuticals quality control and carrying on with the fight against counterfeit medicines or non-compliant with the standards (UMA);
- Implementing a North African project for the coordination of medicines registration systems (UMA);
- Drawing up the final version of the North African project for the coordination of medicines registration systems (UMA);
- Accelerating the implementation of the recommendations of the North African Council of Ministers during the 10th and 11th sessions regarding the integration of the medicines registration process in North African countries (UMA).
Recommendations regarding integration via medicines production
- Implementing a structure gathering North African pharmaceutical industrials (IOPM);
- Ensuring a diversification of the production throughout the integration of the different technologies: injectable forms, aerosols, etc. (Coulibaly A.);
- Ensuring the follow-up of WHO’s indicators aiming at assessing the capacities of the pharmaceutical industry and the measure of the sector’s performances;
- Developing infrastructures, promoting human resources, integrating new information and communication technologies and carrying out technology transfer;
- Starting the integration by the production of vaccines, oncology products, serums and medicines derived from biotechnologies; - Reinforcing the local production capacity via the implementation of an incentive framework favouring investment in this sector (Coulibaly A.);
- Developing the North African cooperation in terms of medicines production (and especially of generic ones);
- Implementing an independent association of medicines manufacturers so that the pharmaceutical industry can benefit from scientific, commercial and industrial exchanges (CIP).