The South African government has announced moves to clear the massive backlog of drug approvals and develop a recovery strategy for the pharmaceutical industry.
The backlog has occurred “due to an unexpected increase of submissions by the pharmaceutical industry for the registration of medicines during the previous three years,” says the regulator, the Medicines Control Council (MCC), adding that the scope of the problem was revealed by the Medical Products Task Team set up by Health Minister Aaron Motsoaledi to identify priority areas in health care that require “immediate attention.” As a result, the MCC is asking all manufacturers for information on drug registration applications which are still in the approvals pipeline.
Since Mr Motsoaledi took over as Health Minister in the government of the African National Congress (ANC) party on May 11, he has declared himself committed to health care reform, which includes making changes to the MCC with the aim of speeding up access to new medicines and widening the availability of generics.
The MCC’s 12 million rand (£990,000) backlog clearance project, which is being undertaken with funding from the UK’s Department for International Development (DFID), has been welcomed by the multinational drug industry association, Innovative Medicines SA (IMSA). Currently, the approval process takes up to four years and more than 2,000 applications are now stuck in the pipeline, says IMSA. Moreover, of the 3,731 applications for both originator and generic product approvals submitted to the MCC during 2003-7, only 2,428 – or two thirds – received approval.
Meantime, Finance Minister Pravin Gordhan has said that more money will be made available for health care when he presents his Medium Term Economic Framework (MTEF) in October. There is no doubt that the health system has suffered, “but we have an energetic Minister of Health who is very determined to ensure that we strengthen the health system, that we strengthen the hospital system, that we deliver antiretrovirals on time and more importantly, lay the platform for national health insurance to come in over a period of time,” Mr Gordhan said last week.
Moreover, on Monday (September 22) delegates at the Bio2Biz conference in Durban were told that the Department of Trade and Industry (DTI) is drawing up a recovery plan for South Africa’s pharmaceutical industry. The country has gone from being a net exporter of health care products to a net importer, with exports in 2007 totaling just 1.05 billion rand compared with imports worth 13.7 billion rand, creating an overall healthcare sector trade deficit of more than 22 billion rand for the year, said Department spokesman Andre Kudlinski.
Moreover, imports of pharmaceuticals in finished dosage form rose 24.8% last year to 10.3 million rand, up from 8.2 million rand in 2007, he added.
The major drawback currently confronting the industry is price controls, while regulatory delays and a lack of incentives for investors are also a problem, said Mr Kudlinski, but the government has targeted the sector as a priority for development, with the aim of boosting domestic production and reducing reliance on exports.
