Essential Laws for Medicines Access - A Pilot Study on National Legislation (Australia, The Netherlands, South Africa and Tonga). Report to the WHO-EMP Department on work undertaken in Geneva, June-August 2010
(2014; 38 pages)


Studies demonstrate that many factors affect universal access to essential medicines. To date, little qualitative and comparative analysis has been directed to the laws that support or impede medicines access. The objective of this pilot study was to create a format for collecting national laws in a uniform manner, so that these may be categorized, typed and analyzed into an evidence base, which is currently not available. The underlying hypothesis is that in countries with good access to essential medicines, a particular body of law or legal infrastructure exists that supports such access. This study was designed to identify such supportive laws, with the ultimate goal to identify, through comparative legal analysis, model essential laws for medicines access (ELMA). Data on access to medicines and legal provisions were collected for a large number of countries (Annex 2). Four countries in different stages of economic development were then selected with national laws in a digital format that could be easily retrieved via on-line libraries and databases. These countries were Australia, The Netherlands, South Africa and Tonga. For these countries a series of queries were conducted on the relevant laws of each. Summary country profiles were made describing the overall structure of each government and health system and the national laws of these four countries were identified and compared (Annexes 3-6).

The results of this pilot study show that Australia and The Netherlands have a comprehensive, consistent and integrated body of substantive laws. The laws and regulations governing medicines access are interrelated and work together in coordinated systems that support all areas covered by the selected progress indicators. Evidence of government commitment and relevant legislation is less comprehensive in our two examples of middle-income countries, South Africa and Tonga. Of these, only South Africa is committed to health at the constitutional level, but not specifically to access to essential medicines.

Our study confirms an earlier general impression that a constitutional mandate committing the government to providing essential medicines is not an essential condition for success. Other legal paths can also achieve the desired result if these frameworks commit the government and if financial provisions are being made. The pilot also confirms that the methodology provides sufficient data and allows for comparison and analysis of multiple different types of legislative provisions from different legal systems. However, information on legal support for price control policies and on evidence-based selection of medicines for reimbursement was difficult to obtain in practice and some more indicators with greater specificity to essential laws for medicines access are needed.

It is anticipated that more country studies will be performed following the same protocol; and that these data will first be collected by researchers, and then interpreted as needed by local lawyers, submitted to a central analysis team and retained in a global data base. It is recommended that the legal information collected this way be made freely accessible to researchers and the public. Such a collection will help ensure a greater level of legal information transparency, improve governance in health, hopefully reduce health disparities and promote the rule of law.

It is our hope that this new collection of model legislation will assist other countries in developing and implementing sound legislation in support of universal access to essential medicines.

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