EAC supports Burundi on fast-tracking of Pharmaceuticals regulations

DEUS NGOWI in Arusha

Head of Corporate Communications and Public Affairs Department at the EAC Secretariat, Mr Owora Othieno

THE East African Community (EAC) Secretariat has facilitated Burundi legislators’ benchmark visit to Tanzania Food and Drugs Authority (TFDA) so as to fast-track and implement the Burundi National Pharmaceuticals Regulation Law that is currently before the Parliament of Burundi.

The Head of Corporate Communications and Public Affairs Department at the EAC Secretariat, Mr Owora Othieno said here yesterday that the 22-member delegation that is being led by MP Felix Niragira also toured ministries responsible for health, agriculture, and trade in Tanzania.

Mr Othieno said that the four day visit that started on Wednesday is also part of the EAC Secretariat’s efforts to enable the government of Burundi establish and fully operationalise the Autorite’ Burundaise de Regulation des Medicaments et des Aliments (ABREMA) as a public autonomous or semiautonomous body and legally designated to oversee effective regulation of food and medicinal products in the country in accordance to the regional and international best practices.

Burundi is the only EAC partner state that has not enacted and implemented strong national pharmaceutical laws through the National Parliament and has not established semi-autonomous National Medicines Regulatory Authorities (NMRAs) in order to promote public health and safety as well as facilitate cross-border trade in medicines, health technologies and other medical products, including enhancing local pharmaceutical manufacturing under the EAC Common Market Protocol.

Burundi is still lagging behind hence denying the country the benefits of the harmonised EAC Regional Guidelines and Standards for Medicines Evaluation and Registration, Good Manufacturing Practices, Quality Management Systems and Information Management Systems as well as the Mutual Reciprocal Recognition and Technical Cooperation with other Partner States and the International Medicines Regulatory Bodies and Agencies.

Mr Othieno unveiled that the study tour was recommended by attendees of a one day high level National Multi-Stakeholders Advocacy and Sensitisation Workshop on strengthening of national pharmaceutical laws and establishment of ABREMA in Burundi that was held on December 7, 2017 at the Panoramique Hotel in Bujumbura, Burundi.

Participants recommended and requested the EAC Secretariat to organise and facilitate the study tour to enable the members of respective committees in Burundi Parliament and technocrats to get firsthand experience on the operations of TFDA and respective ministries in regard to enactment and implementation of National Pharmaceutical and Regulation Law.

Addressing the delegation in Dodoma, the Deputy Minister of Trade, Industry and Investment, Engineer Stella Manyanya commended the commitment of the legislators in the benchmarking visit, having driven a long distance from Dar es Salaam and reaching Dodoma past midnight.

She said the implementation of the EAC Council decision by Burundi on the establishment of national authority responsible for food and drugs would lay an equal playground for the EAC partner states in monitoring regulations harmonisation, an initiative that the partner states had worked on for so long.

She said establishment of national authorities help minimise Non-Tariff Barriers (NTBs). “The commitment of the Republic of Burundi to implement the Council decision is a step forward to resolve some of the unnecessary NTBs in the region,” Engineer Manyaya was quoted as affirming.

Mr Niragira who is also the President of Justice and Human Rights Commission applauded the EAC Secretariat for organising and facilitating the visit, saying it was very fruitful and would enable the Burundi parliamentarians make informed decisions on enacting the National Pharmaceuticals Regulation Law that is before the Assembly. He said Tanzania was chosen for the benchmarking visit because it was a sister partner state and TFDA was well established with long experience.

Officials from the ministries responsible for health, agriculture, and trade shared with the Burundi delegates their various mandates and how they build synergies with TFDA. The Burundi parliamentarians could not meet their counterparts because the Tanzania National Parliament was on Christmas and New Year holidays recess.

On Thursday, the delegation visited the TFDA Headquarters in Dar es Salaam, where its Acting Director General, Dr Danstan Hipolite shared with them the roles and responsibilities of TFDA, its policies, legal framework and governance structure, as an executive government agency under the ministry responsible for health, mandated to control safety, quality and effectiveness of food, medicines, cosmetics and medical devices including vitro diagnostics in Tanzania.