Members of the East African Legislative Assembly (EALA) on Monday, April 19, begun a series of public hearings in Kigali, Rwanda, aimed at gathering stakeholders’ views to improve the EAC Pharmaceutical Bill, 2020. This private Member’s Bill was introduced on the floor of the House by Rwandan MP Francine Rutazana on December 3, 2019 and was then referred to the Committee on General Purpose for consideration. It is premised on Article 118 of the EAC Treaty which provides for cooperation in health and promoting the management of health delivery systems and better planning mechanisms to enhance efficiency of health care services, harmonisation of national health polices and regulation in order to achieve quality health in the Community, among others. In other partner states, the public hearings were conducted from April 11 to 14 which corresponded with the initial week of the commemoration of the 1994 genocide against the Tutsi in Rwanda. Rutazana’s group rescheduled its work programme. Just like other lawmakers did in Burundi, Kenya, Tanzania, South Sudan and Uganda, Rutazana and her team in Kigali are meeting representatives from; the Ministry of EAC Affairs; members of Parliament, chief pharmacists; drugs and medicines regulatory authorities; representatives of medical stores; associations of doctors, and others. They want to eventually come up with an agreed position on the content of the Bill; comments and proposals that seek to improve the Bill discussed; as well as ownership and acceptance of the Bill from the public in the region. But what are the most important clauses in this Bill which has 13 clauses? Here, we take a look at the seven most important ones. 1. Promotion of pharmaceuticals produced within the EAC Article 5 of the draft law states that the Council of Ministers, the central decision-making and governing organ of the bloc, shall establish programmes and policies to promote pharmaceuticals produced within the Community. For the purposes of this section, the Council may establish, implement or direct a Partner State to implement a specific programme or activity intended to promote pharmaceuticals produced in the Community. Programmes or policies established by the Council may include: removing duties on imports of raw materials or equipment used to produce pharmaceutical products in the Community; determining a price preference margin for pharmaceuticals produced within the Community; preference or reservation schemes for procurement of pharmaceuticals produced within the Community; and facilitating and promoting prequalification by the World Health Organisation of pharmaceuticals produced within the EAC. 2. Good manufacturing practices and quality standards Under article 6, it is stipulated that a person producing pharmaceuticals within the Community shall not benefit from any programme, policy or incentive established by the Council under this Act, unless that person produces pharmaceuticals. Effort is being made to ensure that international safety standards are adhered to in accordance with the good manufacturing practices of the World Health Organisation or as determined by the Council to meet the quality standards relating to pharmaceutical products. 3. Preference for pharmaceuticals produced in EAC during public procurement As noted under article 7, every Partner State shall, through specific preference or reservation schemes, prioritise the procurement of medicines produced within the Community. A Partner State or the public body responsible for procurement of medicines shall not discriminate against pharmaceuticals originating from another Partner State during the procurement of medicines. “Producers of pharmaceuticals from different Partner States may jointly participate in public procurements in a Partner State in accordance with the procurement rules of that Partner State,” reads part of the draft law. On sharing of information on pharmaceuticals, the draft law states that a national pharmaceutical authority may share information relating to evaluation, inspection, registration or management of pharmaceuticals with another national pharmaceutical authority. “Information relating to the trade secrets of person producing pharmaceuticals shall not be shared without the consent of that person,” it adds. 4. Essential medicines of the Community Under article 9, it is noted that the Council shall, on the recommendation of the regional Ministers responsible for health, regularly determine and publish in the Gazette, the list of essential medicines of the Community. “The list shall contain all the medicines considered by the Council to be the most effective and safe to meet the most important health needs of the Community.” 5. Access to essential medicines Every Partner State shall ensure that the citizens of that Partner State have access to the medicines specified on the list of Essential Medicines of the Community, reads article 10. “For purposes of ensuring that citizens have access to essential medicines, a Partner State or the National Pharmaceutical Authority designated by the Partner State, may conduct joint evaluations, inspections relating to Good Manufacturing Practices or conclude agreements with another Partner State or National Pharmaceutical Authority to jointly procure or acquire any medicine on the list.” 6. Mutual recognition of registration of medicines In order to promote access to affordable and safe essential medicines, Partner States shall harmonise their procedures and systems for registration of medicines; and the Council shall issue regulations prescribing the mechanism for a Partner State to recognise, evaluations, inspections relating to Good Manufacturing Practices or medicines registered by another Partner State. 7. Protection of public from harmful pharmaceuticals Under article 12, every national pharmaceutical authority shall notify the EAC Secretary General of any pharmaceutical that – is recalled, directed to be removed from the market or deregistered by that authority; or in the opinion of the authority poses a health risk to the public. It is also stipulated that the Secretary General shall publish information relating to the notifications on the website of the Community and take such other appropriate measures to warn the public, as may be necessary.
