New licensing law could compromise over-border pharma exports

Concerns have been raised that new legislation that requires wholesale pharmaceutical distributors based in South Africa to be licensed by the Department of Health’s Medicines Control Council (MCC) could hamper exports into the rest of Africa by causing “excessive and unnecessary” delays in getting the products across the border. And the new legislation could be in effect by early next year after comments on the draft regulation closed at the end of last month, global wholesale practice (GWP) inspector for the Medicines Control Council (MCC), Karen Ford, told delegates at a Savino Del Bene Pharmaceutical and Healthcare Interactive Forum in Johannesburg last week. The new legislation not only requires wholesale distributors to be licensed but affects the packaging, handling, transportation and storage of wholesale products. It also requires additional labelling and documentation – all of which costs valuable time and money, say shippers. Ford said this was to ensure improved safety of the products – although shippers have questioned why the current quality agreement and letter of authority were not sufficient. “Many of us are known entities and already it takes the MCC about 18 months to even acknowledge a change in a registered product, and about three to five years to get a new product registered,” a shipper told FTW. Having to wait for a wholesale licence could mean losing out to a competitor with a similar product. “There is a growing demand in Africa for pharmaceutical products and the end customer isn’t prepared to wait months for a product, they want it ASAP,” she commented. Further concerns have been raised about the MCC’s current transition to becoming the South African Health Products Regulatory Authority (Sahpra) – which was formally established in June this year. The new entity – which will differ from the MCC in size and structure – will have far more regulatory control. Sahpra’s regulatory framework will include medicines, medical devices, and radiation control as well as inspection and enforcement of compliance. According to Ford, this transition could take up to five years and should not adversely affect any operations, but shippers are worried that it could further delay the processing of licences. “There are always snags and major red tape when government entities evolve and change roles and, as a highly competitive industry, we can’t afford to get caught in the middle,” said a shipper. Already 80% of his shipments of over-thecounter medications into neighbouring countries were stopped by MCC inspectors, he added. “Furthermore, with new legislation, there are always periods where clearing agents, border officials and health inspectors need to properly understand procedures and the paperwork required – and that inevitably causes delays as shipments are stopped and checks need to be done and confirmed,” he highlighted. Ford acknowledged the concerns raised, telling FTW that the issuing of wholesale licences was a “new area” for the MCC. “We want to ensure that everything is above board with our processes and nothing slips through the cracks. But we may relax our procedures a little once we have seen how the process works,” she said. The timeframe of the licensing application cycle would be an average of 90 days, she told FTW. “Once the application is received, MCC inspectors will conduct their site visit within 30 days. Their report will be submitted within 30 days and companies will have 30 days in which to respond. Barring any major issues, the licence should then be issued.” Ford pointed out that the MCC had already run a pilot project to issue wholesale licences and carry out inspections within the 90-day period and it had worked. “So it can be done,” she said, adding that there should be no major delays en-route if the documentation was “all correct”.