Mr Speaker, I appear before this august House in response to your summons for me to brief Parliament on the Ebola vaccine trials in Ghana.
Mr Speaker, the summons followed the Statement by the Volta caucus on the floor of the House in which it expressed some reservations on Ebola vaccine trials in the Hohoe District of the Volta Region. While the concerns may have been specifically related to proposed trials in the Hohoe District, there is no gainsaying the fact that the issue has assumed a national dimension and understandably so, given the fear and trepidation that Ebola disease causes in all of us.
Mr Speaker, the outbreak of the Ebola Virus Disease (EVD) last year caught Africa, and indeed, the whole world unawares and totally unprepared. It t r aumatised and decimated many communities in fellow West African countries namely Guinea, Liberia and Sierra Leone.
Mr Speaker, at the height of the epidemic last year, African leaders and especially leaders of the ECOWAS sub- region made urgent appeals to the international community and the World Heal th Organisation (WHO) in particular, to assist, not just in relief operations, but more importantly, in finding a cure or vaccine for the dreaded Ebola Virus Disease(EVD.
His Excellency John Dramani Mahama, our own hardworking President, who was at that time Chairman of the Economic Community of West African States (ECOWAS), provided inspirational leadership, helping to garner international support to deal with the epidemic. Ghana became the operational base of the international relief operations and President Mahama even took the bold decision to visit Ebola-stricken West African countries as an expression of deep concern and manifestation of brotherly love and human solidarity.
Mr Speaker, in response to urgent appeals from leaders in our sub region and the cries of all our peoples, the WHO rallied around pharmaceutical, research and development companies that had prospective candidate medicines and vaccines, some of which were being administered as tr ials on medical personnel who had contracted the disease while working as volunteers in some disease-stricken areas in West Africa.
Mr Speaker, in October 2014, the WHO facilitated a meeting of the African Vaccine Regulatory Forum (AVAREF) in South Africa to consider how to accelerate the process of approving prospective candidate medicines or vaccines. Given the urgency of the situation, participating countries agreed to undertake joint reviews of clinical trial applications in order to reduce the time usually taken to
process applications. The final decision whether to approve clinical trials or not, however, rested with the regulatory agencies in individual countries.
Mr Speaker, subsequent to the meeting in South Africa, the WHO wrote to regulatory bodies of Ghana and four
other West African countries, namely Nigeria, Senegal, Cameroun and Mali, notifying them of the intention of Glaxo Smith Kline (GSK), one of the world's leading pharmaceutical companies, to submit a candidate vaccine for clinical trials in our respective countries.
The WHO subsequently convened a joint review meeting in Geneva on the 14th and 15th of December last year which was attended by a number of international health regulatory bodies including Health Canada, Swissmedic, European Medicines Agency (EMA) and the USA Food and Drugs Administration.
Mr Speaker, following the Geneva meeting, GSK submitted an official application on December 17 to the Ghana Food and Drugs Authority for authorisation to conduct clinical trials. In February 2015, the FDA received another application from Johnson and Johnson to conduct clinical trials in Ghana. Similar applications were made to Kenya, Tanzania and Uganda by Johnson and Johnson.
Mr Speaker, the FDA derives its mandate for the regulation and approval of clinical trials from Part 8 of the Public Health Act of 2012, Act 851. Indeed, since 2004, the Food and Drugs Board (FDB), as it was then known, has built capacity to regulate and monitor clinical trials in Ghana.
Mr Speaker, it is very important to note that since 2004, the FDA (or FDB for that matter) has dealt with 54 applications for