Transparency and Registration of Medicines

Medicines Transparency Alliance (MeTA)
The focus of MeTA, a scheme put forward by the UK Government, is focused on strengthening a developing country's capacity to collect, analyse, disseminate and use data on medicine price, quality, availability and use.

At the launch of MeTA in May 2008, Douglas Alexander, Secretary of State for International Development, said that "Too many people die needlessly because they can't get the medicines they need. There are currently 2 billion people around the world who do not have access to affordable medical services. A lot of medicines are not affordable, they are of poor quality, or they are simply not available. The problems of price, quality and availability can be tackled by improving transparency and access to information. MeTA will provide citizens, healthcare workers and others with information to challenge corruption, excessive pricing and waste. We now have a common approach and by working together millions of lives could be saved."₁

The APG has engaged closely with the Government and was pleased that many of the Group's suggestions were accepted. The theory of MeTA is attractive, but a number of practical concerns remain and these should be addressed in the pilot schemes proposed in seven countries, the first having started in late 2007, with the work being spread over some two years.

1. More information regarding the Medicines Transparency Alliance can be found at: http://www.medicinestransparency.org/index.asp

Registration of medicines in Africa
In some parts of the world there are overarching regulatory authorities responsible for the registration of medicines within that area, such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMEA) in Europe. There is no overarching body for medicine registration in Africa, therefore individual countries have their own licensing arrangements.

The need for some form of harmonised procedures for the registration of medicines in Africa, is widely recognised. The WHO has estimated that "one-third of WHO Member States have no medicines regulatory authority, or at best very limited capacity for regulation of the pharmaceutical market. Regulatory gaps are common, with the informal sector for medicines supply often neglected." (WHO Medicines Strategy 2004-07).

The APG strongly supported the UK Government in setting up a conference of stakeholders in 2009 to ensure medicines are adequately approved through a faster, more harmonised system that would not in any way diminish the quality standard of medicines being approved.