Government plans to give medical practitioners greater freedom to prescribe innovative treatments for patients should not leave pharmaceutical companies unduly exposed to legal claims, a leading expert has warned.
The Department of Health has been running a consultation on the Medical Innovation Bill – which is sponsored in the House of Lords by Lord Saatchi and in the Commons by Conservative MP Michael Ellis – ending on April 25. Discussing the reasons for the bill in Parliament, Health Secretary Jeremy Hunt said: “ the government should do whatever is needed to remove barriers that prevent innovation which can save and improve lives. We must create a climate where clinical pioneers have the freedom to make breakthroughs in treatment.”
Mr Ellis and Lord Saatchi’s bills “correctly identify the threat of litigation as one such barrier. Their hope is that legislation to clarify when medical innovation is responsible will reduce the risks of clinical negligence claims. Their argument is that, with this threat diminished, doctors will be confident to innovate appropriately and responsibly,” the Health Secretary told the House.
“This innovation could lead to major breakthroughs, such as a cure for cancer,” added Mr Hunt.
However, litigation expert Manoj Vaghela, a partner at law firm Pinsent Masons, points out that while the proposals have the potential to significantly enhance health care by giving medical practitioners more freedom to prescribe innovative new treatments, the legal protections for doctors contained within the Bill are not extended to drugs manufacturers.
Companies “may find themselves at risk of being sued where their products were prescribed by doctors in accordance with the new rules but where the treatment fails or causes additional problems for patients,” he warns.
Mr Vaghela proposes that a new compensation fund, similar to the National Vaccine Injury Compensation Program in the US and other similar schemes worldwide, should be created alongside the Bill.
This “would give patients a less expensive and time-consuming means by which to claim redress that they would encounter if trying to sue drugs companies, and would reduce the threat those companies face of being held liable for the actions of doctors they have no control over,” he says.
The government is expected to respond to the consultation in May, and it “will seek to legislate at the earliest opportunity, subject to the results of the consultation,” Mr Hunt has told Parliament.
