The Liberia Medicines and Health Products Regulatory Authority (LMHRA), in collaboration with stakeholders, has concluded a five-year strategic plan (2021-2025) for the effective governance and implementation of medicines regulation in Liberia; and to further ensure that safe, effective, and quality medications are provided to the population.
Making a formal presentation of the strategic plan to a cross-section of stakeholders and donor partners, at a day-long introductory meeting of stakeholders, held in Monrovia, the Managing Director of the LMHRA, Pharmacist Keturah Smith-Chineh, noted that without a guiding tool for medicines regulations, the country will not have the quality of health services desired, therefore, it is high time the narrative is changed by supporting the regulatory authority as it should be because it is the genesis of quality healthcare.
“So in the next five years, the LMHRA wishes to change the narrative of how regulations are implemented not only in Liberia but the sub-region. Because if there is a poor system in place, the population might not have the quality of healthcare desired by all,” the LMHRA Managing Director emphasized.
She added: “As we go through these plans, we pray that our partners take note and begin to support wherever area they can as envisaged by the LMHRA in the next five years.”
Providing the overview of the LMHRA, Dr. Flomoku Miller, Technical Advisor to the LMHRA Managing Director, noted that to ensure that the national medicine supply system, is safe, effective, and good quality medicines reach the Liberian public, the LMHRA continues to audit pharmaceutical manufacturers for Good Manufacturing Practices; conducts an assessment of medicines dossiers through CTD evaluation; issue Marketing Authorization and Conduct quality control and quality assurance activities and as well monitor the safety of medicines.
According to him, to protect the Liberian public from the harmful effects of substandard and counterfeit medicines and health products, the LMHRA conducts container inspections, Premise inspections Post Market Surveillance, Combats drug peddling through confiscation, community & school awareness, radio talk shows, billboard installations, publishing of awareness messages on LMHRA’s website notices, supervise product recalls, incineration of expiries and confiscated medicines and health products from peddlers.
The LMHRA Technical Advisor further intimated that since the ascendency of the current management team, there has been the establishment of new departments, new units, sub-offices, regional offices, recruitment of staff, capacity-building of staff, procurement of vehicles and other logistical material, erection of structures, drafting of new guidelines and regulations as well as the drafting of the new strategic plan.
Despite these achievements outlined, Dr. Miller decried challenges confronting the LMHRA as the full decentralization of the entity, the understaffing of departments, with technical personnel, limited logistics especially vehicles, workspace, software for the various technical departments, completion of the Quality Control Laboratory infrastructure, as well as functioning equipment, and certified Quality Control Laboratory and more capacity building.
Highlighting the five-year Strategic Plan 2021-2025, United States Pharmacopeia PQM+ Consultant, Benjamin Kwame Botwe, said the five years plan was developed based on the mandate given by the Act establishing the LMHRA as well as experiences and lessons learned over the last ten years of the existence of the authority, international best practices and results of some internal and environmental assessments undertaken so far.
According to him, the purpose of this strategic plan is to: design strategies for achieving the vision, mission, and objectives of the authority; provide a long-term perspective of what the authority would look like in the future; develop performance indicators for monitoring and evaluation; development of an operational plan and budget as a basis to seek for both technical and financial assistance to facilitate the achievement of these set objectives.
The USP PQM+ Consultant further mentioned that the process of developing the strategic plan involved an assessment of the state of implementation of the first strategic plan; the self-assessment of the LMHRA on its regulatory functions using the World Health Organization (WHO) Global Benchmarking Tools; further assessment on Quality Management Systems situation by the West African Health Organization (WAHO); all levels of management, staff and various stakeholders and professional groups were engaged for their inputs and buy-in.
He said upon performing a SWOT and PESTEL analysis, the vision and mission statements were developed and the strategic goals were identified to be able to achieve the mission of the authority.
Some of the thematic areas captured in the plan include regulatory system strengthening, legislation and regulations, evaluation and registration, inspections, import and export control, post-market surveillance, Pharmacovigilance and clinical trials, quality control, quality management system, human resource development, harmonization, collaboration and decentralization, financial sustainability communication and information technology.
Mr. Botwe also highlighted that the plan also encapsulates the establishment of an effective and efficient medicines and related products regulatory system; setting up of a quality management system and undertaking operational research activities to support regulatory functions; development and implementation of an effective information management system; promotion of partnership, cooperation, collaboration and decentralization; recruitment, development, and maintenance of adequate human resource capacity and the mobilization of technical and financial resources for the implementation of regulatory functions.
Mr. Botwe emphasized that medicines and health products regulation is meant to ensure safety, efficacy, and quality; hence, the activities of marketing authorization, post-market surveillance, inspections, and quality control laboratory requires a state-of-the-art infrastructure, well-trained and skilled human resources as well as technical and financial assistance.
According to him, the strategic and accompanying operation plan is costed to give opportunity for investment in particular areas and where necessary provide the technical assistance to achieve the objectives because experience shows that government budgetary allocation alone is not enough to ensure full implementation of the plan.
Also speaking, the Director of USP-Ghana and PQM+ West Africa, Mr. Kwasi Poku Boateng, highlighted that USP PQM+ support to the LMHRA includes the establishment of the LMHRA, the implementation of an aspect of the first strategic plan, providing the technical assistance funding from USP, the development of the current strategic plan, support to key regulatory functions, support to products evaluation and registration, training for PMS staff, compliance training for anti-malaria, support to the quality control lab and capacity building of the Inspectorate Department.
PQM+ is working with LMHRA to build its capacity to carry out regulatory functions. PQM+ also supported LMHRA to develop its current five-year Strategic Plan (2021-2025) to strengthen the governance of the medical product quality assurance system.