Essential medicines and health products

Challenges

The increasing globalization of commerce and trade, and the merging of pharmaceutical companies, are internationalizing pharmaceutical production. International pharmaceutical norms and standards are thus more important than ever before since they serve as global tools aiming to ensure safety and quality of medicines. One of WHO’s roles is to continue to develop such international norms and standards, and to help countries implementing them.

Safety and quality of pharmaceuticals are also being promoted through regional and international efforts to harmonize drug regulation, such as those led by, ASEAN (Association of South-East Asian Nations), CAN (Andean Community), CADREAC (The Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries), the European Union, Gulf Cooperation Council (GCC), the International Conference on Harmonisation (ICH), MERCOSUR (Southern Common Market) the Pan American Network on Drug Regulatory Harmonization (PANDRH) and the Southern African Development Community (SADC). These efforts are to be welcomed since international consensus on quality, safety and efficacy standards can speed up access to medicines.

Important key elements are quality assurance guidance texts in the areas of production, testing, and distribution of medicines. These include guidance on: good manufacturing practices; quality assurance for regulatory approval; prequalification of medicines, laboratories, and supply agencies; model certificates for quality assurance-related activities; quality control testing; new specifications for inclusion in the Basic Tests series and the International Pharmacopoeia; and International Chemical Reference Standards; the programme on International Nonproprietary Names (INN) which is used to identify each pharmaceutical substance or active ingredient by a unique and universally accessible name. All these elements are intended for use by national regulatory authorities, manufacturers, and other interested parties. The need to scale up access to affordable quality medicines for HIV/AIDS, TB, and malaria in developing countries has raised many challenges within the pharmaceutical world. These challenges come on top of the reality that among national regulatory authorities there is a variable capacity to interpret and apply existing norms and standards and guidelines on regulation, quality control, nomenclature, and classification of pharmaceuticals. WHO will work to strengthen and promote global norms, standards, and guidelines for the quality, safety, and efficacy of medicine. That said, quality assurance levels differ from country to country; not all countries have the same capacity and resources for implementing agreements on drug regulation harmonization. Drug regulation experts accordingly recommend a step-wise approach for achieving the highest level of medicines safety, regulation and quality assurance in each country. WHO’s role is to identify areas in which further guidance needs to be developed for preliminary and intermediate steps. Simple screening tests for detecting substandard and counterfeit drugs are just one example.

More generally, WHO’s task is to help countries consider the implications of the relevant harmonization agreements. This is particularly true with regard to ICH, which currently does not include representatives from all developing countries. WHO needs to evaluate the impact of ICH guidelines, and advise non-ICH Member States on how to adapt existing guidelines to their own needs and conditions.

At the same time WHO must ensure that its own normative guidelines, such as its guidelines on good manufacturing practice (GMP), are maintained and updated. The GMP guidelines aim to provide globally accepted and applicable standards for ensuring that products are consistently produced and controlled according to quality standards.

Rapidly evolving science and technology are likewise creating problems for regulatory authorities everywhere. Training and specialization requirements for dealing with the ever-increasing complexity of assessing technologically advanced products can be especially burdensome. But by developing norms and standards for use in new areas of health technology and product development, WHO can reduce this problem, while at the same time helping to minimize unnecessary duplication of scientific expertise and effort.

Globalization of the pharmaceutical industry is also bringing other safety issues to the fore. For example, non-prescription medicines are becoming increasingly available to the general public in all countries, including through such channels as the Internet. Yet resources for monitoring their safety and quality are often lacking.