Essential drugs and medicines

Situation analysis

The Mozambican pharmaceutical sector is going through very important changes due to significant progress made in the economic and health sectors following the post-war period.

In Mozambique, it is estimated that only 40-50% of the population have regular access to public health services and more than 75% of the population uses traditional medicine primarily to treat health-related problems. Mozambique has also an outdated national essential medicines (last revision 2002) and pharmaceutical law (published in 1998). In addition, there is no distinct national regulatory authority.

In 2005, a joint mid-term evaluation of the Plano Estratégico do Sector de Saúde (PESS) 2001-2005-2010 confirms that the availability of high quality medicines in all provinces is one of the main achievements and the most important progress made in the pharmaceutical sector.

However, despite the positive result, the evaluation report pointed out several issues and challenges that remained to be tackled to improve the performance of the pharmaceutical sector in Mozambique. For example, tertiary and quaternary hospitals frequently experience a low level of satisfaction for the requisitions they made for specialized medicines. Furthermore, an audit conducted in 2003 by the Ministry of Planning and Finance showed shortcomings in drug distribution.

In 2005, an external evaluation of the pharmaceutical sector was conducted by five highly qualified experts in the pharmaceutical sector and quality control and laboratory techniques. This evaluation provided a clear assessment and made recommendations in the area of procurement of medicines, storage and distribution of medicines, drug regulation, and rational use of medicines, human resources, quality control, monitoring and evaluation . The external evaluation of the pharmaceutical sector also provided a roadmap for improving the pharmaceutical sector of Mozambique.

This evaluation was followed by several successive missions aimed at providing technical assistance in areas such as:

• Support in the area of procurement, storage and distribution (Central de Medicamentos e Artigos Médicos – CMAM)
• National regulatory authority
• Report finalisation and Plano of Action
• Pre-qualification of CMAM suppliers

Challenges

The Mozambican pharmaceutical sector is facing several challenges which can be grouped in four main categories: those related to policy and regulation, those related to the functioning of the Central Medical Store (CMAM), those related to human resources and other general issues and challenges.

Medicine regulatory authority

• Inexistence of a national pharmaceutical policy;
• Ineffectiveness of the medicine regulatory law (4/98), (i.e. registration of medicines, and quality control) particularly important as the country is reliant on imported drugs;
• Lack of transparency in pricing of drugs in the private sector.

Central Medical Store (CMAM)

• Inadequate quantification of estimates at national, provincial and district levels;
• Long procurement cycle;
• Lack of clarity in the institutional and functional situation of CMAM within the Ministry of Health;
• Two different sectors of the MOH are responsible for the management of Medical supplies (DAG-Centro de Abastecimento) and Drugs (DNS-CMAM). This result, for example, in 2 separate logistics supply systems for injectable drugs and the syringes needed to inject these drugs.
• CMAM has been working over the last two years on the development of a drug management information system (Sistema de Informação e Gestão de Medicamentos - SIGM) that will change radically the way it is working and integrate all its planning, procurement, warehousing and distribution functions.

Human resources

• There is a crucial lack of staff (quantity and quality) for the whole pharmaceutical sector;
• Total reliance on external technical assistance for CMAM;
• Reduced capacity of the pharmaceutical sector to take into account the increased needs of medicines and medical supplies due to AIDS, Tuberculosis and Malaria.

Other challenges

• Cost-recovery of medicines: the performance and effectiveness of the cost recovery of medicines in raising revenues and maintaining equity in access to health services;
• Low level of budget execution;
• Inefficient drug management and use of medicines in the public health sector;
• Low clients satisfaction with long queues and long waiting time in hospital and other health facilities pharmacies;
• High level of "inventory discrepancies" and not documented issues in health facilities outpatient and ward pharmacies.

Achievements

• External evaluation of the pharmaceutical sector;
• Trained 30 national technicians in WHO level 2 survey methodologies;
• Trained national senior staff in pharmaceutical sector management and regulation issues;
• Played catalytic role and participated actively to the national pharmaceutical sector coordination meeting where the results of the external evaluation of the pharmaceutical sector were presented and validated;
• Roadmap for improving the pharmaceutical sector validated, and respective budget drafted;
• Detailed work plan for improving the National Laboratory of Quality Control validated;
• Technical assistance provided in finalizing the process of prequalification of suppliers of essential medicines of Mozambique;
• Celebration of the 30th anniversary of the introduction of the concept of "Essential Medicines" in Mozambique.
• Essential drugs and medicines

Next steps

• Strengthening human resources in quantity and quality for the whole pharmaceutical sector;
• Strengthening CMAM capacity to carry out key functions related to procurement, warehousing and distribution of essential medicines (presently outsourced to MEDIMOC);
• Supporting the creation of a National Regulatory Authority and strengthen the National Laboratory for Quality Control;
• Promoting the revision of the national pharmaceutical policy and improving medicines registration;
• Promoting and monitoring equitable access to affordable and high quality essential medicines and their rational use;
• Promoting the implementation of WHO's strategy for traditional medicine;
• Reviewing and updating the pre-qualification of CMAM suppliers.