This section provides the results of the analysis of the pharmaceutical regulation reforms with supporting quotes from the study participants and document reviews. Some informants were given code numbers to maintain confidentiality.
Some informants said that the agenda for the reforms had been in the making for a couple of years. They said that in 2006, the Pharmacy Council presented a concept paper at a pharmacists’ conference, highlighting some sections of the TFDA Act of 2003 which they believed needed to be harmonized with its functions. The Pharmacy Council and the TFDA unanimously agreed to convene a meeting under the guidance of the then Pharmaceutical Supplies Unit (PSU) to develop a proposal to be submitted to the Minister for Health and Social Welfare. Within a short time, the two institutions managed to identify key sections that they proposed to discuss in the following meetings. Informants said that the Pharmacy Council unilaterally forwarded the proposal they were working on with the TFDA to the Minister of Health and Social Welfare for further action.
I remember the two institutions were working closely together after that conference on how to harmonize some of the problematic areas of the TFDA Act No. 1 of 2003. There was a meeting and we produced a paper highlighting specific sections which we thought we were supposed to work on. The section about premise registrations was one of them. I do not know what happened afterwards, we came to realize that the paper was already at the Ministry of Health and Social Welfare, we were all stunned! (Participant 3)
The content of the Bill and the enacted Pharmacy Act, 2011
The proposed bill aimed to repeal section 21 of the TFDA Act No. 1 of 2003, which deals with the registration of premises and issuance of permits for businesses dealing with medicines . The bill proposed that the Pharmacy Council should have the mandate to register premises and issue permits for the sale, dispensing and supply of medicinal products. These permits were categorized as retail, wholesale, institutional or of any other business as the Council may deem necessary for the purposes of the Act . We learned through the interviews and document reviews that behind this “goodwill” to improve the regulation of the business of pharmacy there was a hidden interest by pharmacists. Many pharmacists who contributed about the topic in the discussion forum shared the same view that the proposed law should be supported because it protects the interests of pharmacists. One of them commented:
One of the core functions of the Pharmacy Council is to protect the interests of pharmaceutical personnel, and since the Pharmacy Council will always have a registrar who is a pharmacist then we are safe. So why not put the premises under the Pharmacy Council to secure our interests from other professions? (Participant 15)
Document reviews showed that, since the enactment of the TFDA Act No. 1 of 2003 and its subsequent implementation, the Government of Tanzania, through the Ministry of Health and Social Welfare, has invested a lot of resources in building up the capacity of the TFDA as a regulatory authority to protect its people from sub-standard and counterfeit medicines. This includes a significant increase in the number of employees, from 52 in 2003 to almost 200 by 2011, to run the new operations provided in the portfolio.
In 2006, the Ministry of Health and Social Welfare delegated to the Prime Minister’s Office, Regional and Local Government (PMO-RALG), some of the powers and functions of the TFDA through the Tanzania Food & Drugs Delegation of Powers Order of 2006, amended in 2007 . The TFDA had worked with PMO-RALG to establish Council Food and Drug Committees (CFDC) that were mandated to discharge some of the regulatory functions related to operating premises (other than pharmacies) dealing with the sale of pharmaceuticals in their locality. In the long term, this would have decentralized regulation closer to where it was needed, since the majority of the Councils had already established CFDCs with a reporting structure to the TFDA.
To a large extent, those who were against the policy reforms were cautious about the capacity of the Pharmacy Council to deal with the regulation of pharmacy businesses. Many felt there was no justification for the Pharmacy Council to engage with the business of pharmacy since the TFDA was already making good progress in that area. One Member of Parliament warned that these reforms would have counterproductive consequences, hence compromising the achievements of the TFDA in that area .
All of Section IV of the bill which deals with the business of pharmacy should be removed; the bill should deal with professional issues only. This is how we can do justice to our nation; otherwise we will enter into major problems. We want to start new things for no good reasons, the Ministry of Health and Social Welfare must tell us what were the shortcomings observed when the business of Pharmacy was under the TFDA, that’s the only way we can endorse this bill. – Parliamentary Contribution to the Pharmacy Bill 2010 .
In spite of strong opposition from Members of Parliament, the enacted Pharmacy Act, 2011, retained Section IV of the bill, which authorizes the Pharmacy Council to register premises and issue permits for businesses dealing with medicines. Specifically, the Pharmacy Council was mandated to issue permits for retail, distribution, institutional or any other business as it may deem fit for the purposes of the Act, while the TFDA was left with the manufacturing and wholesale permits . In our opinion, this decision was reached to create a win-win situation for the two institutions but unfortunately created more contradictions among their clients. While the main responsibility of the Pharmacy Council is to regulate professional practice and training, some stakeholders wondered how this function relates to the registration of premises. It is also not well understood how the once contradictory bill was passed into an Act despite strong opposition from Members of Parliament to cede the TFDA’s roles to the Pharmacy Council .
The process that produced the bill and its subsequent submission to Parliament was not transparent and was conducted ad hoc. The process was initiated by the Pharmacy Council as an agenda setter. The proposed bill was endorsed by the Ministry of Health and Social Welfare, which submitted it to Parliament. The bill was returned to the Parliamentary Standing Committee for Social Welfare (PSCSW) for more discussions with stakeholders, who were perceived not to have been involved to a sufficient extent. Some of the informants who participated in the discussions about the bill within the PSCSW said that they witnessed a lot of lobbying activities for political support among the two rival groups.
It was all about lobbying for political support, some people lobbied to be part of the committee, others lobbied the members of the committee from outside, and it was chaotic! (Participant who attended PSCSW meeting)
There were both visible and hidden participants in the policy review process; hence, it was difficult to know exactly who was involved and who was not. However, officials in the Pharmacy Council, the TFDA and the Ministry of Health and Social Welfare were the most prominent actors behind the pharmaceutical regulation reforms. The Pharmacy Council as the agenda setter, along with the Ministry of Health and Social Welfare, supported the reforms while the TFDA opposed them. The TFDA was accused of working through informal political channels to block the bill and some officials were even threatened with dismissal from their positions.
Stakeholders at the micro level, such as community pharmacists and owners of premises, were minimally involved. Informants said that only a few representatives, particularly from the pharmacy training institutions, were involved. In an attempt to address concerns about the inadequate involvement of stakeholders, the Parliamentary Standing Committee for Social Welfare invited some stakeholders to discuss the content of the bill after it had been removed from Parliament. Information about who was invited was not made public and it was not obvious whose opinions these representatives were going to convey in the meeting. It was during this time that there was an outcry from the community of pharmacists that the bill was again being treated with secrecy without their full involvement. The bill was not made available to the public and it was only through informal channels that hard copies were accessible. The opinions of stakeholders who were not invited by the Parliamentary Standing Committee for Social Welfare were unlikely to be chanelled onto the discussion table.
(…) of all the things, the most interesting and annoying one is where stakeholders were bypassed and instead lobbyists went to Parliament in Dodoma. Is this where we have reached! What were they worried about? Everything with this bill suggests it is for personal interests and short sightedness. (Participant 50)