How to get the maximum possible of your team: My experience at the National Medicines and Poisons Board (13th November 2007 – 5th September 2010)

Historical Background

The Government of Sudan has emphasized the importance of drug control and the need to centralize it since the colonization era. The Pharmacy and Poisons Act (PPA) was introduced in 1939. In 1963, the Government of Sudan adopted a new PPA and a Standing Committee for the Registration of Medicine was established within the Federal Ministry of Health (FMOH) under the Public Health Board to take responsibility for medicine registration before its importation or marketing in Sudan and for regulations endorsement. In addition to its responsibility for medicine registration, the committee was also responsible for the licensing and inspection of pharmaceutical premises.

The 2001 PPA and its provisions established the Federal Pharmacy and Poisons Board (FPPB). ?The FPPB renamed the National Medicines and Poisons Board (NMPB) in May 2009 (This is discussed in more detail later in section 4 below). This Board was under the supervision of the Minister for Health. All implementation authority for the PPA (2001) was given to its Secretariat General (The executive arm of the Board), which was the General Directorate of Pharmacy at FMOH. The Board was responsible for the appraisal and registration of all medicine and other pharmaceuticals on the Sudan market; for the verification of the competence of manufacturing companies and their manufacturing plants and their ability to produce substances or products of high quality before registering these companies and allowing them to apply to register their products in Sudan; and (when necessary) for inspecting and auditing these companies and their manufacturing units to verify their compliance with the GMP (Good Manufacturing Practices) recommended by World Health Organization (WHO).

A further reform took place in November 2007, when the Council of Ministers issued the decree No. 228/2007. ?According to this decree, which has been signed by the President of the republic, the FPPB Board was re-appointed. The Decree gives the Secretariat General of the NMPB the legislative authority to conduct its business as an autonomous organization under the direct supervision of the thirty-five-member Board of Directors chaired by the State Minister of Health. The FPPB as an institution was under direct supervision of the Federal Minister of Health. The FPPB’S the Board of Directors represents the main stakeholders, including its main customers, such as the President of the Association of Medicines Importers; the president of the Chamber of the National Medicine Manufacturers; the presidents of the General Professional Unions of Sudanese Pharmacists, Doctors, Dentists and Veterinarians; and the Chairperson of the National Assembly (the Parliament) Committee on Health, Environment and Population. The stakeholders’ representatives are selected according to their posts in these public and private institutions from which the FPPB functions may best benefit. The FPPB Board provided a good example of a high-performance Board of Administration. The Board meetings were regular and held four times per year.

On 13th November 2007, I have been promoted by a decree of Council of Ministers to be the founder Secretary General of the semi-autonomous FPPB. The first task was to transfer relevant staff from the federal ministries of health and animal resources. Some of pharmacists, who worked at the General Directorate of Pharmacy, became the core staff of the new FPPB. After finding a venue to host the FPPB, all regulatory business moved from the General Directorate of Pharmacy – University Street to the FPPB rented building in Amarat neighborhood - Street No. 21 over the weekend, and FPPB resumed its business as usual on early morning Sunday. In Sudan, such movement of public organizations may take days, if not weeks. With support of pharmacists Mohamed Ali and Salah Othman, the administrator Loai spent Friday and the whole Saturday night in preparing the venue for staff and the FPPB’s customers. By 7:30 am Sunday morning, he managed to dots the i's and crosses the t's. Every employee found his desk as he/she left it on Thursday, but in a different place.?

The staff were highly motivated to the extent that they worked until late in the evening without overtime. They took public transport, which was scarce and very crowded, to go back home. Sometimes I felt so embarrassed, when I saw female pharmacists Tahani and Salma on the street waiting for the bus. I used to offer them a lift to their homes in the opposite direction to my home. It took me one hour driving, but I enjoyed it, and my colleagues highly appreciated this service. Although I did it twice or so, the workforce at the NMPB acknowledged it and get motivated.

I told all FPPB’s staff in our Monday one-hour meeting: "We all in a position to establish a technically, administratively and financially independent medicines regulatory authority for the first time in Sudan. Let us work harder to establish a European organization in Sudan - i.e. creation of an environment, where a high standard is expected from all employees”. I also told them that we have a historical opportunity to establish a competent, non-bureaucratic and customer-oriented regulatory authority with multi-disciplinary team structure in order to ensure marketing of safe, effective and quality-assured medicines and other medical products.

As a leader of the FPPB, I instilled self confidence in the senior staff and asked them to do the same with their subordinates. In our meetings, I encouraged the staff to make decisions by following the spirit of the law and its regulations, instead of strictly adhere to the letter. I told them, it was better to make a wrong decision than take no decision. Generally, civil service employees fear penalization. I used to affirm my colleagues that I was here to amicably correct wrong decisions, by requesting those who have been affected to submit an appeal to the Secretary General. As the Secretary General of the FPPB, I provide support, assistance and protection to enable staff carrying out their tasks by doing right things in conducive working conditions. In this regard, I found the following quotation of the US former president Ronald Reagan (1911 – 2004) very useful https://www.brainyquote.com/quotes/ronald_reagan_130693:"Surround yourself with the best people you can find, delegate authority and don't interfere as long as the policy you have decided upon is being carried out"

In the following sections of this spotlight, I tell my story as the founder Secretary General of the independent Secretariat General of the FPPB. I shined light on twelve striking examples of the main accomplishments in around thirty months, despite the constraints of resources. I ended the spotlight by drawing a conclusion from the FPPB’s experience in getting the maximum possible of the limited resources by motivating the civil service staff.

Achievements

When I left to be the Director General of the National Medical Supplies Fund (NMSF), on 5th September 2010, after almost three years, highly motivated NMPB's staff were able to achieve the maximum outcome of the limited resources available. The following are some examples of the great jobs done by the NMPB’s Board of Directors and its Secretariat General staff in the span of thirty three months in order to protect Sudanese people and public health against substandard and/or falsified medicines:

1.????? Budget: Without finances, none of regulatory functions can be carried out. In its first fiscal year as autonomous organization, FPPB succeeded in convincing Ministry of Finance to increase its operating budget from only SDG0.018 million in 2007 (i.e. when it was part of the FMOH budget) to SDG1.8 million in 2008 the first ever FPPB fiscal year after its transformation. ?

2.????? Organogram: The Secretariat General proposed the organizational organogram and scale of posts and the terms of service of the FPPB’s employees and submitted the same to the competent minister to recommend to the Council of Ministers for approval. The approved organogram comprised twenty compared to the eighteen senior posts (i.e. Scales four, three and two) for the FMOH.?

3.????? Two-year strategic Plan: A team was nominated to draft a two-year strategic plan. The team was informed that the strategy must be based on a thorough and objective assessment of the FPPB's current situation and takes into account relevant experiences and lessons learned from other medicines regulatory authorities in developed and developing countries. Despite the tough financial situation, staff were able to develop a two-year strategic plan with clear vision and agreed upon goals that had been approved by the consensus of the FPPB's 35-member Board of Directors.

4.????? Medicines and Poisons Act 2009: There was a strong political will and commitment from the government to establish a stringent medicines regulatory system in Sudan as a way of assuring safety, efficacy and quality of medicines circulating in the market, especially after the adoption of liberal economy, which clearly stated in the Interim Constitution of Sudan 2005. Upon a request from the FMOH, the Secretariat General drafted Medicines and Poisons Act 2008. The National Assembly has passed the bill in May 2009 and accordingly the Federal Pharmacy and Poisons Board was renamed the National Medicines and Poisons Board (NMPB). According to the new Medicines and Poisons Act 2009, government has given power to the Board to become more autonomous in executing its regulatory functions (i.e. technically, administratively and financially independent), under direct supervision of the Federal Minister of Health. This new legal status enables Sudanese Medicines Regulatory Authority to assure safety, efficacy and quality of medicines, medical devices and related products. In addition, NMPB has become more autonomous in executing its functions by collecting and utilizing the fees described for the various regulatory services. Further, the Act limits the scope of activities of the Board to regulatory functions for the products covered under its jurisdiction (Activities previously carried out by the Board, e.g. medicines policy, updating of National List of Essential Medicines, human resources for pharmacy, rational use of medicines are safely carried out by General Directorate of Pharmacy [the former Executive Secretariat of the Board] under direct supervision of the MOH Undersecretary). Finally, NMPB is capable of hiring its own staff with clear remuneration package that will provide incentive for them not to move to the private sector and discourage potential corrupt practices.

5.????? Regulations: According to the Medicines and Poisons Act 2009, the NMPB is responsible for developing regulations that help in achieving its goals. In this regard, the Secretariat General (November 2007 - September 2010), enacted more comprehensive regulations that provide for the establishment of the strong medicines regulatory authority. For example, it initiated ten different regulations to govern the marketing authorization of medicines, medical devices, cosmetics, pricing of medicines, clinical trials, and narcotics. All these proposed regulations have been approved by the NMPB’s Board of Directors. The Board also has passed an internal regulation for the organization of its activities, which ensured that the Board adheres to high standards of ethical and corporate behavior. Most of these regulations have been approved for the first time in NMPB’s history. When the founding Secretary General left in September 2010, the NMPB was governed by a set of regulations, policies, strategies and procedures that are sound and consistent to a large extent with WHO recommendations and guidelines on medicine regulatory best practice.

6.????? Technical Committees: In addition to already existing Committees on Registration of Medicines; Registration of Veterinary medicines, and Registration of Medicines from Natural Sources, the Secretariat General proposed ten different standing technical committees (thanks to USP and collaborators [USP – DQ&IP, 2007]), which has been approved by the FPPB’s Board for the first time in the history of medicines regulation in Sudan. Examples of these standing technical committees are: Committee on Registration of Medical Device; Appellate Committee chaired by the Chairman of the Board (the State Minister for Health); Committee on Registration of Cosmetics; Committee on Registration of Pharmaceutical of Plants Origin (Natural Products); Narcotics Committee; Legislation Committee; and Committee on Clinical Trials.

7.????? Registration Requirements: To ensure that pharmaceutical products and medical devices circulating in Sudan are safe, effective and of assured-quality, NMPB updated requirements of medicines registration to include, for the first time, submission of a bioequivalence study for certain medicines. To do so, two NMPB’s pharmacists were trained in Jordan on how to appraise bioequivalence studies.? The Secretariat General also initiated development of new requirements for the registration of biological products; medical devices; and cosmetics. Lastly, to speed up the registration process, the Board adopted the ICH[1] https://www.ich.org/ Common Technical Documents (CTD) format to enhance the robust accelerated registration of safe, effective and quality products. The Secretariat General organized a 5-day workshop facilitated by a British expert to train NMPB technical staff on how to critically appraise the CTD.

8.????? Evidence-based Decisions: Since November 2007, it was the policy of the NMPB that technical decisions of all technical committees must be based on scientific evidence to ensure the most favorable outcomes without bias. The shift from knowledge-based and individual experience to evidence-based policies and informed decision-making was the major change. This new evidence-based approach in decision-making has helped the NMPB’s technical committees to win all the cases escalated by the customers (i.e. importers and manufacturers) to the Appellate Committee. The approach also enhanced customers’ confidence in the NMPB’s decision-making process, promoted transparency and reduced opportunities for corrupt and fraudulent conduct. The websites of the WHO, ICH, and stringent medicines regulatory authorities, such as US FDA https://www.fda.gov/ , EMA https://www.ema.europa.eu/en , and MHRA https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency were the main source of information. To equip its staff and members of technical committees with required up-to-date information about medicines and other health products, the NMPB gives a free copy of the latest edition of the British National Formulary (BNF)[2] to its pharmacists. The Secretary General approached the Health Internetwork Access to Research Initiative[3] https://portal.research4life.org/content/hinari to get a username and password for NMBP. The NMPB’s Board and its staff have free access of up to 14,000 journals, 46,000 e-books and 100 other information resource. For example, a 2008 paper by Giezen and colleagues on “Safety-related regulatory actions for biologicals approved in the United States and the European Union” helped the Secretary General convince colleagues in the Medicines Registration Committee to develop requirements for the registration of biological products.

9.????? Medicines Pricing: In 2007, the WHO reported that the medicine pricing mechanism applied by the regulatory authority in Sudan is not robust enough. As a result, the prices of medicines were reported to be higher than in comparable countries in the region. To provide evidence, the Secretary General of the NMPB with support of one of his staff (Mohamed Ali and Yahia 2012) conducted a study in 2008 to evaluate the capacity of the FPPB’s pricing mechanism in controlling prices of imported medicines. The study, which was presented to the Board, concluded that the pricing system was of limited benefit in controlling medicine prices in Sudan. To remedy the situation and to enhance affordability, and based on this study, the Secretary General drafted a regulation on medicine pricing. On 1st September 2010, the NMPB’s Board approved the Regulation on Pricing of Registered Pharmaceutical Products. After almost two years, in 2013, the NMPB applied these regulations to revise the CIF prices of 1,000 types of medicine. The reduction in CIF (i.e. Cost, Insurance and Freight) ranged from 10% to > 90%, and surprisingly the importers of these medicines without objection continue to import them according to the new CIF prices.

10.? Ceiling: To maximize the benefit from the limited resources available for the NMPB, there should be an added value from the registration of more alternatives of the same generic medicine. In this regards, the Secretariat General submitted a study to the NMPB’s Board to limit the number of the registered finished products to ten generic alternatives. The brand product and locally manufactured generics are excluded. The NMPB’s Board accepted the recommendation and passed a ceiling resolution in 2009.

11.? Human Resources Development: The NMPB adopted a comprehensive staff development program. For example, a training course on GMP inspection facilitated by an expert from the UK to have a roster of NMPB’s professional inspectors was conducted in 2009. In August 2008, WHO financed a workshop facilitated by a British expert to train NMPB’s pharmacists responsible for inspecting and licensing of the pharmaceuticals distributors. Lastly, two pharmacists have their MSc in the University of Bradford, the UK in Pharmaceutical Services and Medicines Control and three pharmacists have completed their fellowship degree in Management of Pharmaceutical Services in Sudanese National Medical Specialization Board.

12.? Adverse Drug Reactions: A pharmacist was appointed as focal person to monitor Adverse Drug Reactions. In 2008, FPPB became a member of the Uppsala Monitoring Centre. Later in 2013, NMPB established a Pharmacovigilance Directorate for monitoring, detecting, assessing, understanding, and preventing of adverse effects or other medicine-related problems.

Conclusion

To establish an organization from the scratch, leaders require a high regard for staff, in general, and senior management, in particular, with emphasis on shared responsibility, involvement of the staff in developing organization vision and mission. In doing so, the leadership must be totally committed to agree upon vision and mission. In this case study, the clear vision inspired all NMPB's employees, especially pharmacists, to perform better even during tough times of foundation phase (when there was no budget to offer them transport or to pay them overtime, let alone incentives for outstanding performance). The leadership should keep staff motivated by delegating them and providing support needed to accomplish the organization’s mission. The NMPB’s experience revealed that highly motivated staff are critical to overcome contextual challenges. It also revealed that to get the maximum possible of the staff, it is equally important to strengthen their technical capacities. As has been well-reported by Silva (2013), without clear vision, the reform process will lead to confusion and incompatibilities. When responsibility has been delegated, adequate authority should be given to enable the subordinates serve the organization goals. True leaders should not tell their staff details of doing things. Rather, agreed with them upon a vision, a mission and goals, and let them develop an action plan to achieve the vision, the mission and the goals. Lastly, in line with Silva (2013), the NMPB’s experience proved that financial incentives do not always affect the productivity of employees.

References

Mohamed Ali, G.K. and Yahia, A.Y., 2012. Controlling medicine prices in Sudan: the challenge of recently established medicine regulatory agency. East Mediterranean Health Journal; 18: 811- 820.

Giezen, T.H. et al 2008. ?Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA; 300(16): 1887-1896 (doi:10.1001/jama.300.16.1887)

Silva, T.D., 2013. Essential Management Skills for Pharmacy and Business Managers, CRC Press, New York.

USP – DQ&IP, 2007. United States Pharmacopeia Drug Quality and Information Program and collaborators. Ensuring the Quality of Medicines in Resource-Limited Countries: An Operational Guide. Rockville, Md.: The United States Pharmacopeial Convention. Available online: www.usp.org/worldwide/dqi/resources/technicalReports.

[1] The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.

[2] The BNF is published jointly by the British Medical Journal (BMJ) Publishing Group Ltd and the Royal Pharmaceutical Society (RPS) Publishing, London, UK.

[3] HINARI is the program set up by WHO, together with major publishers, to enable low- and middle- income countries to gain access to one of the world's largest collections of biomedical and health literature.