Pharmaceuticals--strategic considerations in health reforms in Pakistan.

Pharmaceuticals are critical to the functioning of healthcare systems which require a sustainable supply of quality, efficacious, and safe essential medicines. With this as a context, the Gateway Paper in its capacity as a suggested roadmap for health reforms within Pakistan stressed on the need for a pharmaceutical policy to be directed towards improving people's access to medicines; within this framework a number of issues have been highlighted. Weaknesses in the current legislation on drugs, in particular gaps, which have emerged contemporaneously with reference to the post WTO situation and the technology boom, have been discussed and the incongruity between the drug policies and policies in the other sectors addressed. The Gateway Paper makes a strong case to establish a statutory semi-autonomous drug regulatory authority in order to ensure stricter implementation of the Drug Law, which needs to be amended to bridge the current gaps. The paper lays emphasis on a formal quality assurance mechanism and the need to build capacity to implement regulation in this regard. Lack of clarity in the current pricing formula has been flagged as a key issue and the need highlighted to develop a pricing formula that is predictable, transparent and acceptable to the stakeholders, yet one that does not create access and affordability issues for the poor and disadvantaged. The paper addresses gaps in the process of drug registration in Pakistan and stresses on the need to redefine its scope and ensure its stricter enforcement. Unethical market practices and irrational use of drugs have been discussed and the need for transparently implementing standard operating procedures for drug selecting, procurement, storage, dispensing and rational prescribing and the introduction of appropriate evidence based education, managerial and regulatory interventions in this regard, highlighted. The myriad of reasons which lead to the shortage of drugs and to the mushrooming of spurious, counterfeit and sub-standard drugs in the market have also been the subject of discussion as have been issues relating to the present size and utilization of the National Essential Drug List.