The use of ineffective, poor quality, harmful medicines can result in therapeutic failure, exacerbation of disease, resistance to medicines and sometimes death. It also undermines confidence in health systems, health professionals, pharmaceutical manufacturers and distributors. Money spent on ineffective, poor quality medicines is wasted - whether by consumers or governments. Governments need to establish strong national regulatory authorities (NRAs), to ensure that the manufacture, trade and use of medicines are regulated effectively, to protect and promote public health.
Box 1. Main reasons for regulating medicines
• There is an ‘information asymmetry’ between those who manufacture/sell medicines and patients/consumers, who are not equipped to make independent assessments of the quality, safety or efficacy of their medicines;
• Desperate patients may buy ineffective or even toxic medicines;
• Misuse of medicines, such as antibiotics, can have serious implications for individual and public health;
• Once medicines are prescribed to patients, others, such as dispensers and drug sellers, become involved. Regulation is needed to ensure that these interactions do not adversely affect treatment outcomes.