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 of 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 that 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. The legislation and regulations 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 through 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Pharmaceutical legislation in many developing countries may be weak, outdated, or missing important regulatory provisions.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. In addition, 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 provided 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 supported a participatory approach to the development of relevant pharmaceutical legislation. SIAPS also helped support in-country stakeholders in preparing for implementation to reap the benefits of newly ratified legislation.