Nature

LAUNCH OF THE NIGERIA NATIONAL PHARMACEUTICAL TRACEABILITY STRATEGY AND INAUGRATION OF THE TRACEABLITY STEERING COMMITTEE

The Nigeria Pharmaceutical Traceability Strategy was launched on Thursday the 8th of October 2020 by The Honourable Minister of Health, Dr. Osagie Ehanire. The Director-General of National Agency for Food and Drug Administration and Control of Nigeria (NAFDAC), Professor Moji Christianah Adeyeye was present at the launch as well as The Permanent Secretary, Federal Ministry of Health, Mr Abdullaziz Abdullahi. The meeting was held at the Ministers meeting room at The Federal Ministry of Health, Abuja and Online in compliance with Covid-19 safety guidelines. The Minister also inaugurated the Steering Committee for the implementation of the Pharmaceutical Traceability Strategy. The Honourable Minister and the Director-General of NAFDAC gave speeches with The Director-General providing key insights into the traceability journey so far. Stakeholders present at this meeting included The Federal Ministry of Health, NAFDAC, The Pharmacists’ Council of Nigeria, representatives of Pharma Industry Associations such as Pharmaceutical Manufacturers Group-Manufacturers Association of Nigeria (PMG-MAN) and Importers: The Nigerian Representatives of Overseas Pharmaceutical Manufacturers and Association of Pharmaceutical Importers of Nigeria. Pharmacy Associations such as the Pharmaceutical Society of Nigeria and the Association of Community Pharmacists of Nigeria were present as well Developmental Partners such as USAID, TGF and GHSC-PSM. The Association of food, Beverages and Tobacco Employers of Nigeria, GS1 Nigeria and the African Resource Centre, a Health Systems supply chain partner were also present at this meeting. These stakeholders make up the Traceability Steering Committee that will drive the implementation of Traceability in Nigeria. In its report on the event on its twitter account, the authority of Federal Ministry of Health said: “The launch of the Nigeria Pharmaceutical Traceability Strategy today demonstrates the commitment of the Nigerian government to improving access to quality of medicines and other health commodities in line with the 2nd National Strategic Health Development plan.”

Minister’s Speech:

  • The challenge of poor visibility in the pharmaceutical supply chain in Nigeria necessitates the adoption of innovative approaches and complementary partnerships to disrupt the cycle of wastages from expired commodities, shortages, infiltration of substandard and falsified products, diversion and pilferage of products in the health sector.
  • The launch of the Nigeria Pharmaceutical Traceability Strategy today demonstrates the commitment of the Federal Government of Nigeria to improving access to quality medicines and other health commodities in line with the second National Strategic Health Development Plan. Today’s launch and inauguration of the Traceability Steering Committee is also in line with the Ministry’s efforts at achieving goal number three (3) of the United Nation’s Sustainable Development Goals (SDGs): Good Health and Well-being of the citizenry.
  • The Nigeria Pharmaceutical Traceability Strategy is the outcome of the collaborative efforts of government, private sector, and development partner stakeholders across the health sector in Nigeria to define the vision and strategy for Nigeria, and highlight the steps required to develop an enabling environment for implementation of pharmaceutical traceability in the public and private sector supply chains using global standards.
  • The gains of implementing pharmaceutical traceability are noteworthy. Traceability will provide visibility of medicines from plant to patient; promote trust in the pharmaceutical sector and healthcare system; increase opportunity for trade of domestically manufactured pharmaceuticals; increase data quality to support pharmacovigilance; decrease infiltration of substandard and falsified (SF) medications; and ultimately, increase patient safety.
  • Further to the launch of the Nigeria Pharmaceutical Traceability Strategy and the need to establish a governance structure to lead the strategy, collaboration, outreach, and oversight of the implementation, I hereby inaugurate the National Traceability Steering Committee.
  • This committee is constituted of a team of stakeholders across public and private sector organizations that will provide strategic direction, decision-making authority, resource mobilization, and oversight of implementation activities to achieve the strategic objectives outlined in the Nigeria Pharmaceutical Traceability Strategy document.
  • The committee will be co-chaired by the Director, Food & Drugs Services of the Federal Ministry of Health (FMOH) and the Director, Drug Registration and Regulatory Affairs of the National Agency for Food and Drug Administration and Control (NAFDAC).
He recognized the contributions of Nigeria’s Healthcare development partners, Agencies of Government and esteemed private sector stakeholders and still solicited their continued support and cooperation to achieve this laudable goal of pharmaceutical traceability in Nigeria. On the occasion, Director-General of National Agency for Food and Drug Administration and Control of Nigeria (NAFDAC), Professor Moji Christianah Adeyeye, in her remarks said the Nigeria Pharmaceutical Traceability Strategy that was being launched presented priority objectives that will guide the development of a comprehensive operational plan.

DG’s Speech:

  • Safeguarding the health of the Nation is a daunting task in the face of the chaotic drug distribution system currently existing in Nigeria. The falsification and diversion of health commodities carry very serious health and economic consequences. The consideration of these consequences vis-à-vis the mandate of NAFDAC to regulate and control, among other things, the distribution of drugs and other regulated products is sufficient motivation to adopt and implement strategies that can assist in the fight against the menace of substandard and falsified medicines (SFs), and thereby improve the regulatory control of the medicines supply chain in Nigeria by providing visibility across the value chain.
  • In September 2019, NAFDAC hosted the largest gathering of African medicines regulatory authorities ever assembled to promote medicines traceability using global standards. With support from the World Bank’s Global Steering Committee for Quality Assurance and an historic Call to Action, some 25 African countries and six (6) health financing and donor organizations declared their commitment to implementing GS1 traceability standards to help achieve greater supply chain integrity and fight fake medicines in their respective countries.
  • The Nigeria Pharmaceutical Traceability Strategy being launched today presents NAFDAC’s priority objectives that guided the development of a comprehensive operational plan, and contributes to strengthening the existing regulatory and legal frameworks required to publish and enforce a traceability regulation and related guidelines. The launching of this strategy document is the first step in positioning Nigeria to be a leader in driving traceability of pharmaceuticals on the Africa continent.
  • NAFDAC is committed to the implementation of pharmaceutical traceability in Nigeria as part of the regulatory strengthening and underscoring of its mandate. To this end, the Agency has developed a 5-Year Traceability Implementation plan in line with the objectives of the Nigeria Pharmaceutical Traceability Strategy to achieve supply chain visibility and strengthen its pharmacovigilance activities against the scourge of SFs and Medical Devices. The Agency has also established a Traceability Office (GS1 Desk) and a Technical Working Group to drive the activities in the 5-year implementation plan.
  • I am acutely aware of the spike in falsified medicines that many countries face as a result of COVID-19 related supply chain disruptions. We must therefore act fast as we anticipate the distribution of a COVID-19 vaccine, a commodity that will be in short supply, to protect it from falsification and diversion. The emergence of falsified versions of the COVID-19 vaccine would do irreparable harm to the already challenging task of vaccine literacy and acceptance.
  • We collectively face one of the largest and most challenging medicines distribution efforts ever. The technology exists to quickly create what I would call a “lean traceability” solution that will help regulatory agencies and donor institutions work together to quickly identify and remove falsified COVID-19 vaccines from distribution.
  • Finally, I acknowledge the support of the Honorable Minister and his team at the Ministry, and the contributions of all our stakeholders and partners, and I look forward to your continued collaboration and support.

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