Laws and Regulations

Creating a Robust ‘Regulatory Framework’

Inefficacious, poor-quality, or unsafe medicines and vaccines can exacerbate symptoms, worsen health outcomes, and even cause death. They can also contribute to treatment resistance, fuel the spread of communicable diseases, and erode confidence in public health programs. Consumers cannot assess the quality of the medicines they receive, and even the safest medicines can be potentially dangerous when used incorrectly. For all these reasons, medicines require careful and appropriate regulation.

Sound legislation is critical to the establishment of an effective national regulatory framework and should be complemented by specific regulations which together serve to control the availability, prescribing, and dispensing of medicines; the provision of product information; and the licensing, accreditation, and oversight of pharmaceutical establishments and professional staff. These should also provide for the establishment and operation of a national regulatory agency to assess the safety, quality, and efficacy of medicines; ensure the safe and ethical conduct of clinical trials; and monitor the safety of medicines though post-marketing surveillance mechanisms.

Pharmaceutical legislation in many developing countries may be weak, outdated, or missing important regulatory provisions. Without an adequate regulatory framework, medicines that are fake, of poor quality, or reflect a poor benefit/risk balance may enter the market. Additionally, manufacturing, distribution, laboratory and dispensing facilities may not meet safety or quality standards, and health care practitioners may lack the necessary competencies to provide effective patient care. Effective legislation, developed in a transparent and participatory manner, not only reinforces principles of good governance but also increases the likelihood that its implementation will be acceptable, feasible, and,  above all, enforceable.

SIAPS provides technical assistance to country governments to advocate for, develop, and enact practical, enforceable legislation supported by the rule of law; develop sufficient regulatory capacity; and introduce and apply appropriate technologies. By engaging a broad range of stakeholders—including ministries of health, ministries of finance, and other relevant public sector entities , as well as civil society organizations, professional associations, and advocacy groups—SIAPS supports a participatory approach to the development of relevant pharmaceutical legislation. SIAPS also helps support in-country stakeholders in preparing for implementation to reap the benefits of newly ratified legislation.

In Swaziland, for example, SIAPS has provided extensive support to the Ministry of Health in progressing two key pieces of legislation: the Medicines and Related Substances Control Bill and the Pharmacy Bill, which together will replace existing legislation dating back to 1929. The two bills, which were developed through an extensive stakeholder consultative process facilitated by SIAPS’ predecessor program, together provide for the establishment of the first-ever Medicines Regulatory Authority and a Pharmacy Council to regulate the pharmaceutical sector. SIAPS has continued this work, supporting the Ministry of Health in its efforts to present the bills for legal drafting and legislative approval, resubmit them to the new parliament and cabinet following the 2013 election, and advocate for their finalization and enactment.