National Medicine Policy PHARMACEUTICALS

PRESENTATION OUTLINE What is it? History of National Drug Policy Background Lesotho’s NMP aim What are its objectives? Components of NMP Overview of components Actors involved Characteristics of a NMP Assessment questions

What is it? It is a political commitment and a guide for action that shows how the GOV will ensure that efficacious and safe medicines of good quality are affordable, accessible and rationally used. It is a well established endorsed framework based on partnerships (WHO). Governments, commonwealth, states, territories (SADC) and actors work together to promote the objectives of the NMP

HISTORY OF NDPs 1985 Nairobi Conference of Experts on rational Use of Drugs 1987 Working group of Experts to draft guidelines for NDP’s 1988 Guidelines for NDP’s released 1995 Expert Committee on NDPs met report issued 2002 New Guidelines were published

BACKGROUND Medicines play a critical role in protecting, maintaining and restoring people’s health Access of medicines is a concern for all national governments Poor availability is a major problem for LDCs Changing patterns of morbidity and Trade Agreements impact on access to medicines. Political values, economic and legislation situations impact on access as well.

Background conti…… These access problems have persisted despite the efforts by GOVs, development agencies and WHO to improve on access to essential medicines. The reasons for failure to achieve universal coverage and rational use are complex and differ among Countries and involve a wide range of stakeholders

Lesotho’s NMP Aim: To improve and sustain, within the available resources , the health of the population of Lesotho by treating, curing, reducing or preventing disease conditions through the use of safe, effective, good quality, affordable medicines in both public and private sector. it aims to improve positive health outcomes for all Basotho through their access to and wise use of medicines

What are its objectives To ensure availability of medicines that meet the 4 criterions; quality, safety efficacy and affordability To control, supervise and evaluate the quality of medicines To promote rational use of medicines To promote local production of medicines To be a basis for development of medicines legislation and its enforcement To guide HR development, ensure their retention and proper deployment

Components of NMP Legislation, regulation and guidelines(drugs of abuse Act 2008 and donation guidelines) Selection of medicines (STGs, EML & national formulary) Supply and distribution (NDSO) Quality Assurance (QC Lab is lacking, GPP exist) Rational Use of medicines (3-5 items per prescription & 1-2 antibiotics out of 54% of prescription) Financing and Pricing (no policy on pricing, GOV spend over M50 million) Local production (LPC 51% GOV) Monitoring & Evaluation of NDP’s Medicines information and Pharmacovigilance Human Resources Development (NUL & NHTC challenge of absorption) International and regional Cooperation (Exists) Traditional and complimentary medicines Research and development

OVERVIEW OF COMPONENTS Each component has a crucial part in the overall policy! Emphasizing one component at the expense of others, weakens the entire policy Many different actors are involved. Some are outside MoH, some outside GOV, some outside country

ACTORS INVOLVED Doctors, specialists, public/private Pharmacists retail and manufacturing Local and international producers, importers Consumers/Patients Media Regulators Insurance Companies ETC

CHARACTERISTICS OF NMP Must fit within the framework of the MOH care system. Goals should be consistent with broader health objectives Health policy and the level of service are important determinants of medicines policy and define the range of choices and options. Implementation of an effective medicines policy promotes confidence in and use of health services Planners need to be aware and not experts in all areas

Assessment questions? Does Lesotho have a NMP? Does it contain the objectives and strategies based on priority problems? Do laws exist that specify the GOV’s responsibility in ensuring equitable access to essential medicines? Does an implementation plan exist to put the policy into practice? Is the policy monitored regularly? Are legal mechanisms available to file complaints about lack of access?

So what? IS ACCESS TO MEDICINES A ROLE OF INTERLLECTUAL PROPERTY LAW AND POLICY ONLY? THANK YOU