Africa’s biggest generic drug maker, Aspen Pharmacare, has lost its appeal against the €5.2m fine levied by the Italian Competition Authority over the price of some of its cancer drugs, a development that comes hard on the heels of Tuesday’s news that it is to be investigated by the Competition Commission in SA.
The Italian case relates to the prices of a portfolio of off-patent cancer drugs that Aspen acquired from GlaxoSmithKline several years ago, and that it recently increased. Aspen’s conduct relating to the price of these drugs is also under the microscope in SA, although the prices of the drugs in question have remained relatively stable as they are regulated tightly by the Department of Health.
Aspen said on Wednesday it had noted the abridged judgment handed down by the Italian court and was awaiting the release of the full reasons for the judgment to determine whether it would appeal to the Italian Council of State appeal court.
Aspen’s head of strategic trade, Stavros Nicolaou, said the cancer drugs in question had not had price increases in Italy for the past 40 to 60 years, despite increases in the cost of production, and were typically used as drugs of last resort by a small number of patients. The list price of a generic equivalent of one of these drugs was more than double the Aspen product’s, he said.
On Tuesday, the South African Competition Commission said it was launching an investigation into the price of cancer drugs, homing in on Aspen and multinational pharmaceutical manufacturers Roche and Pfizer.
Commissioner Thembinkosi Bonakele said the commission had not discussed the investigations with the Department of Health, which regulates private sector drug prices. "It is a sensitive matter, and we need to be independent," he said.
The commission said it was investigating Aspen for alleged abuse of market dominance for its off-patent cancer drugs Myleran, Leukeran and Alkeran, which had no generic rivals.
Aspen acquired these drugs in a portfolio of products it bought from GlaxoSmithKline in December 2009.
Nicolaou said Aspen had not driven up the price of these drugs after their acquisition and had only instituted the increases permitted by the Department of Health. For example, the price of a pack of 25 x 2mg Leukeran tablets was R241.61 (excluding VAT) in February 2009, when it was still sold by GlaxoSmithKline, and now cost R369.79 (excluding VAT), said Nicolaou.
The price increases introduced by Aspen were in line with the medicine-pricing regulatory framework and averaged 6% a year from 2009 to 2017, he said.
SA’s medicine pricing regulations stipulate that pharmaceutical manufacturers must sell their products at the same price to all their customers in the private sector, regardless of the volumes bought.
They also control the permitted mark-ups at every stage of the supply chain. Typically manufacturers get one price increase a year, which is approved by the health minister.
Nicolaou said Myleran, Leukeran and Alkeran were affordable, fully reimbursed by medical schemes and had a combined yearly turnover of just R3.2m. A month’s supply of Leukeran cost R2,000-R4,000 (excluding VAT).
There were no generic rivals in SA because this was a very small market for these products, with limited prospects. "It don’t think any other player would see a market for them," he said.
Roche is being investigated on the price of its breast cancer drugs Herceptin and Herclone, while Pfizer is under scrutiny for the price of its lung cancer drug Xalkori.
The Fix the Patent Laws coalition, which recently campaigned for lower breast cancer drug prices, welcomed the commission’s investigation.
"In SA, the annual price currently charged by Roche in the private sector for trastuzumab [Herceptin] is R516,700, while the few public facilities which can access it do so at a lower price of around R211,920 per year," the coalition said.
"[Roche] maintains its high prices in every way possible and it holds multiple ever-greened patents on trastuzumab in certain countries.
"In SA, for example, multiple patents extend Roche’s monopoly until 2033," Fix the Patent Laws said.