Thursday, 17 November 2011

Adcock Ingram vs MCC: A worrying legal battle

Adcock Ingram vs MCC: A worrying legal battle - News - Mail & Guardian Online:

The court battle that played out between pharmaceuticals giant Adcock Ingram and the Medicines Control Council (MCC) this week has raised questions about the health department and the state attorney's capacity to handle legal challenges.

On Tuesday, Judge Eberhardt Bertelsmann rescinded a settlement agreement that allowed Adcock Ingram to continue to sell Synap Forte, Lentogesic and Doxyfene; painkillers that contain the ingredient dextropropoxyphene (DPP). The drug brings in an annual turnover of R180-million for the company.

The MCC says it has tracked concerns regarding the safety of DPP for a number of years and, after the drug was banned by the European Union, US, UK, Singapore and New Zealand, embarked on a series of consultations with its expert panels to decide whether South Africa should follow suit. A decision was made to ban the drug in mid-April this year. Other pharmaceutical companies, such as Aspen Pharmacare, accepted the ruling, but Adcock Ingram chose to challenge the ban.

The company claimed the drug is widely used in other parts of the world; that its own study found the drug to be safe and questioned the rigour of the US study that found the DPP to be dangerous. It also pointed out that in South Africa DPP-containing drugs are schedule five drugs that require a prescription and so are not as prone to abuse as they were in Europe.

But these issues are moot. The MCC's expert panels considered these factors during their deliberations and still concluded that DPP should be banned.

Adcock Ingram's only option has been to lodge an appeal with a committee set up by the minister of health. The company did so and, at the same time, demanded that the MCC hold off on the ban until the appeal had been heard. That's where things started going wrong.

The MCC sent out a circular, asking doctors to stop prescribing DPP-containing medication. But Adcock Ingram tried to interdict the MCC from implementing the ban and to withdraw the circular. The MCC instructed the head of legal services in the national health department, Sello Ramasala, to oppose the application. Health department director general Precious Matsoso also gave "explicit and unambiguous instructions" that she would oppose this move in order to protect the public from harm.

Settlement ideas
The idea of a settlement was discussed with legal services but no terms were agreed on and no approval for such a settlement was given to Isaac Chowe, the state attorney representing the health department and the MCC.

A draft settlement was drawn up but was never shown to or signed by the MCC and health department representatives.

When the matter came up in court, Adcock Ingram's legal representatives were present but no representatives from the MCC or the health department were present. And yet, somehow, the settlement agreement was made an order of court.

The state attorney did not inform the MCC that this had happened and MCC only heard about the court order later, from a member of the public.

In an affidavit presented as part of the court proceedings, Chowe said he had acted in good faith and that he had acted on the assumption that Ramasela, as head of legal services, had received a mandate to accept the settlement. Ramasela is no longer employed by the health department and did not give evidence in the case.

This brings us to the North Gauteng High Court on Tuesday afternoon. Judge Bertelsman was quite scathing in his assessment of the facts, saying that he was dismayed with the conduct of the state attorney and that he had not met the professional standards to which he should aspire. He also chose not to grant costs in favour of the MCC, thus showing his dissatisfaction with the way the matter was handled from their side as well.

Bertelsman described the matter as a "most unfortunate error" but it could more adequately be described as a non-event that turned into a crisis through shoddy legal work. The case has been painted as a victory for public health officials against big pharma in a case involving big money. That it may be, but it is also a frightening example of poor legal advice and poor legal practice in the health department and at the state attorney's office.

With the implementation of national health insurance on the horizon, it's certain the health department may face many such legal battles against better organised and better resourced private companies in future.

This incident does little to reassure the public that the state is capable of handling itself professionally and correctly in such cases.

When asked for comment, health department spokesperson Fidel Hadebe said the department was confident that the state legal machinery would be able to deal with whatever legal challenges may arise.

"I don't see how one incident can be used as a basis to doubt the state law machinery to perform in the future," he said. "It would be best not to step into the realm of speculation."