Import and Export of Products
Abstract
It is the right of all humans to have access to safe, quality and effective medicines. This seeks to expound on the problems of drug manufacturing and challenges of accessing medicines in West Africa, and evaluate the strategies being adopted by international developmental partners and the governments to address them. West Africa is uniquely diverse in culture (having English, French and Portuguese speaking people) but generally affected by the same diseases (e.g., malaria, HIV/AIDS, and Tuberculosis). In this developmentally beleaguered region, drug development and manufacturing are still stuck in their embryonic stages where medicine distribution is chaotic and insufficiently regulated.
This also examines the strategies and policies being implemented to salvage the situation. It is irrevocably clear that solving the challenges of providing safe medication to West Africa is a collective responsibility - the government (through legislation, strategic regulations and policies), medicines manufacturers (adoption of Good Manufacturing Practices and ethics), regulators (through persuasion and enforcement of rules), regulatory consultants, the patients (empowered, informed about their rights and courage and willingness to report drug reactions and discernible counterfeiting), the international development partners and all other stake holders in the health care sector have roles to play in ensuring that the public has access to quality safe and efficacious medicines.
GUIDELINES ON IMPORT PROCEDURES FOR MEDICAL PRODUCTS
Public health considerations demand that medical products should not be treated in the same way as ordinary commodities.Their manufacturing and subsequent handling within the distribution chain, both nationally and internationally, must conform to prescribed standards and be rigorously controlled.These precautions serve to assure that patients receive quality - assured medical products, and to prevent the infiltration of substandard and suspected falsified medical products into the supply system.
Key activities and standards applied
Medicines key prequalification activities are:
- assessment of product dossiers (for finished pharmaceutical products (FPPs) or master files (for active pharmaceutical ingredients (APIs
- inspection of manufacturing and clinical sites
- organization of quality control testing of products.
WHO also prequalifies quality control laboratories (QCLs), specifically those QCLs that carry out chemical and microbiological testing of medicines.
OBJECTIVES AND SCOPE
- These guidelines are directed to all parties involved in the importation of medical products, including NRAs, competent trade ministries, customs authorities, port authorities and importing agents.
- They are intended to promote efficiency in applying relevant regulations, to simplify the checking and handling of medical products for import, inter alia, to provide a basis for collaboration between the various interested parties.
- They are applicable to medical products destined for use within the country of import and are intended to be adopted into prevailing national procedures and legal requirements.
LEGAL RESPONSIBILITIES
- The importation of medical products should be done in accordance with national and regional legislation and should be enforced by the NRA and other relevant authorities.
- National and regional guidelines providing recommendations on the implementation of legislation should be drawn up by the NRA or the Ministry of Health, if a NRA is not formally established, in collaboration with the customs authority and other responsible agencies and organizations.
- The import of pharmaceutical products should be undertaken by an importer or agency authorized by the NRA as per national and regional legislation.This normally does not include pharmaceutical products in transit.
- The import of all medical products should be channelled exclusively through custom posts or ports specifically authorized for this purpose.This is also applicable to medical products moving through the networking global commerce(such as, the World Wide Web / Internet).
Medicines Regulation
In the ECOWAS region, member states have in place basic legal framework for the regulation and control of the manufacture, distribution and utilization of medicines for human use. Situational analysis shows the existence of two different systems that serve to regulate health - related products within the region.The English - speaking countries have a system in which the regulatory functions are centralized in a semi - autonomous / autonomous body; the French and Portuguese-speaking system has regulatory functions shared between several bodies under the authority of the Ministry of Health. Assessment of NMRAs in 2008 by WHO and in 2011, by AU/ NEPAD - WAHO, both showed major deficiencies in the regulatory capacities of the NMRAs. Medicine regulation in the sub-region is still problematic, a situation precipitated by weak infrastructure, weak enforcement power and lack of cooperation from other law enforcement agencies, inadequate human resource capacity, over-reliance on imported pharmaceuticals, lack of bio - analysis facilities for pre - qualification, and lack of an avenue for information exchange between agencies.The medicines regulatory sector is also faced with the problems of poor motivation and low retention of staff; high levels of counterfeit and illicit medicines and lack of harmonization of medicines regulation.
There were also differences in the requirements for medicines registration in member countries There is need to improve, and some of the actions required include the restructuring or establishment of NMRAs to enable them to undertake their regulatory activities more effectively, developing and implementing comprehensive guidelines and procedures for drug registration and strengthening human capacity at NMRAs in Partner States.
It is a general consensus among NMRAs that the various institutional authorities agree on a common system on which all the pharmaceutical policy harmonization and regulation issues would depend.Given the diversity and severity of health issues afflicting West Africans, there was a compelling need to harmonize health policies, practices and standards among ECOWAS Member States.The fast - spreading illicit medicines markets and the sophistication in counterfeit medicines meant that in the absence of a unified and collaborative approach to combating these problems at the regional level, gains made by local - and national - level campaigns would be lost.Acknowledging this reality, ECOWAS committed itself to bringing about true regional integration in the health sector to ensure the highest possible standard of health for all West Africans.’s evidenced-based treatment guidelines (WHO Essential Medicine List);
Subsequently, the NMRAs have agreed to work towards a region-wide approach to reviewing the institutional and legal framework for medicines regulation, dossier evaluation, inspections, local production of essential medicines including traditional medicines, illegal markets and counterfeiting, quality control and pharmacovigilance.In this regard, and in support of harmonization of medicines registration across the ECOWAS region, WAHO has funded the development of the Common Technical Document(CTD) and training manual for medicines registration harmonization, which was validated and adopted by NMRAs in March 2011, in Bobo - Dioulasso, Burkina Faso.WAHO trained 45 NMRAs regulators from seven (7) Member States of ECOWAS on the medicines registration harmonization common technical document in April 17 - 19, 2013.A further 15 regulators were also trained on Good Manufacturing Practice(GMP) based on WHO Modules 1, 2, 3, conducted in three sessions in Nigeria, Cape Verde and Benin from March 2010 –March 2011.To strengthen the MRH process in the ECOWAS region a project proposal was sent to AU / NEPAD Consortium in March, 2011 for financial and technical support.
Drug Control
objective of the ECOWAS’ drug program is to considerably reduce the incidence of drug trafficking, drug abuse and related organized crime on peace, security, economic and human development in ECOWAS Member States. The immediate objective (or purpose) of the drug programme is to gradually establish a sustained regional capacity to monitor, coordinate and harmonize drug policies in West Africa in line with the ECOWAS Political Declaration, Regional Action and Operational Plans. In order to achieve this objective, four main results are envisaged for the duration of the Regional Action Plan.
- Improved ECOWAS drug advisory, monitoring and coordination capacityHarmonized data on drug abuse epidemiology and data collection
- Identification and diffusion of good regional practices on drug prevention and treatment
- Improved regional law enforcement and judicial cooperation
