Medicines Transparency Alliance10/10/2015 Updates on Quality Presentations et al. John Allotey Manager, Business Developments LaGray Chemical Company Limited Nsawam, Ghana

Medicines Transparency Alliance Key Issues Quality issues are very complex issues Quality vital in access to medicines Unavailability of appropriate data – Decisions made based on inadequate information or influences of donors Existence of counterfeit and sub-standard medicines Capacity to ensure good quality medicines 10/10/2015

Medicines Transparency Alliance Successes Successful completion of studies leading to necessary regulatory outcomes – Data for Change in legislation – Mapping of pharmacies in Bishkek Regulatory Interventions undertaken to address problems – Withdrawal of products – Re-analysis of retained samples – Communication to providers and public – Withdrawal of all unregistered products – Intensified Post market surveillance 10/10/2015

Medicines Transparency Alliance Challenges Communication with different players, red tape-ism Legislation gaps Regulation and post market surveillance weakness Awareness creation for prescribers, dispensers and patients The future of the mini labs??? Sensitivities surrounding quality – Good communication – Engagement of relevant stakeholders Education of consumers on the existence of good quality generics 10/10/2015

Medicines Transparency Alliance Lessons Learned Increased enforcement of regulatory requirements is essential to ensure medicines are of right quality The minilab technique has tremendous impact on quality testing of medicines MeTA should seek ways of facilitating support in capacity building for local manufacturers Need to strengthen the Post-market surveillance activities of national regulators Every little support helps and MeTA support has been highly beneficial 10/10/2015

Medicines Transparency Alliance In Conclusion Develop policy solutions that reduce risks due to low quality drugs and increase confidence in the system (acceptance of generic drugs!) Complete PARADIGM SHIFT required to shift focus from “big pharma” to availability of quality generics?? MeTA as a multi-stakeholder group is key in achieving Need to secure support to prosecute this agenda! 10/10/2015

Medicines Transparency Alliance Thank you John Allotey Skype: johnnie_allotey Mobile number: Website: 10/10/2015