Draft bill tabled for new medicines oversight agency

Draft bill tabled for new medicines oversight agency

• Kindle
• 

•  
• 
  

Clip this article

DRAFT legislation that aims to establish a new regulatory agency for medicines has been tabled in Parliament for the second time this year, a development that will be closely watched by the pharmaceuticals industry hamstrung by the slow pace of the under-resourced Medicines Control Council (MCC).
The MCC is widely regarded as doing a thorough and impartial job in assessing the safety and efficacy of medicines, but has frustrated pharmaceutical companies and researchers because it takes too long to make decisions.
The council has a backlog of 2,900 applications to register medicines, mostly generics, MCC registrar Mandisa Hela told Parliament on Wednesday.
"With the current infrastructure it is an uphill battle. It is not going to be solved unless we get additional (resources)," she told MPs when she briefed them on the draft Medicines and Related Substances Amendment Bill.
"We are engaging with the Treasury to get additional funding so we can get people to help with the assessments (but) it takes two years for someone to be trained. We may get the money but the results will not be instantaneous."
The backlog had become significantly worse in the past decade, partly because of a policy decision in 2003 to encourage the use of generic medicines, which led to a surge in registration of applications. More recently, the MCC had faced a significant increase in applications to change suppliers of active pharmaceutical ingredients, as drug companies sought to cut costs by sourcing cheaper inputs.
Regulator
The bill paves the way for the Department of Health to replace the MCC with the South African Health Products Regulatory Agency (Sahpra), which will have much wider scope.
It will bring scrutiny to bear on sectors of the market that have until now been unregulated, including medical devices and diagnostics. It will also be responsible for foodstuffs, cosmetics, and complementary medicines.
The bill was submitted to Parliament in February, but was among the many pieces of legislation that were not considered by MPs ahead of the general election in April. It is now back on the agenda of Parliament’s committee on health, which is expected to hold public hearings shortly.
It is the government’s second attempt at creating enabling legis-lation for Sahpra, after it failed to enact amendments to the Medicines and Related Substances Act in 2008 due to technical issues.
One of the key changes in the bill is a new governance structure in which Sahpra’s CEO has the authority to appoint technical committees, and will report to a board of 10 to 15 experts appointed by the health minister.
Approval
The previous version had a CE appointed by the health minister, with the minister given final authority for the approval of new products, a structure critics said would have left the agency vulnerable to political interference. The bill provides for the new agency to sit outside the civil service, unlike the MCC, which is housed within the Department of Health.
The change was intended to allow the agency to attract top talent by offering salaries higher than those allowed for civil servants, which were determined by the Department of Public Service and Administration, said Ms Hela.
One of the issues likely to be raised at the coming hearings is the bill’s secrecy clauses.
University of KwaZulu-Natal pharmacologist Andy Gray previously told Business Day this would make it difficult for the public to follow the agency’s decision-making processes. Decisions made by expert committees and the CEO should be transparent to ensure there was no political interference, he said in February.



Pradeep Kumar Shukla
PGDM 3rd sem