Out-Law News | 01 Jul 2014 | 12:56 pm | 5 min. read
The Medical Innovation Bill received its second reading in the House of Lords on Friday last week and will now face further scrutiny by peers in committee. However, the Bill is to be amended to give doctors a greater say in whether proposed alternative treatments for conditions they specialise in are appropriate, Earl Howe, the parliamentary under-secretary of state for health confirmed during the Lords debate.
"The government believe that oversight should come from other doctors with experience and expertise in dealing with the condition in question, in line with the existing Bolam test for clinical negligence," Earl Howe said. "For that reason, the government believe that amendments are needed to the Bill so that it can as closely as possible reflect the desire to ... 'bring forward' the Bolam test."
The Medical Innovation Bill has been proposed by Lord Saatchi as a means by which to encourage doctors to responsibly innovate when prescribing medical treatments without a fear of being held liable for negligence should those treatments fail.
Under the Bill, doctors could not be held liable for negligence if they decided to "depart from the existing range of accepted treatments for a condition if the decision is taken in accordance with a process which is accountable, transparent and allows full consideration of all relevant matters".
That process includes consulting with "appropriately qualified colleagues, including any relevant multi-disciplinary team", giving advance notification to their "responsible officer", considering the opinions or requests of the patient and "obtaining any consents required by law".
In addition, the doctors would have to consider "all matters that appear to the doctor to be reasonably necessary to be considered in order to reach a clinical judgment, including assessment and comparison of the actual or probable risks and consequences of different treatments". Doctors would only be able to administer the alternative treatment for the purpose of acting in "the best interests of the patient".
The Department for Health held a consultation on a previous version of the Bill earlier this year. More than 18,000 patients, doctors and institutions responded to the consultation, with the majority broadly supportive of Lord Saatchi's proposals. There are already guidelines for doctors on prescribing and managing medicines and devices that refer to the use of unlicensed medicines for treating patients that have been developed by the General Medical Council.
Expert in life sciences Helen Cline of Pinsent Masons, the law firm behind Out-Law.com, said of the Medical Innovation Bill: "Concerns around safety, liability and insurance sometimes influence a clinician's decision to prescribe a new unlicensed medicine. This bill, along with other initiatives such as NICE evidence summaries on unlicensed and off label medicines and the recently announced MHRA Early Access to Medicines Scheme are creating an environment to support the clinician and patient's decision to use an innovative unlicensed or off-label treatment where there are no clinically appropriate licensed alternatives."
In a recent paper, Pinsent Masons examined how new accelerated access schemes in the UK and Europe could potentially impact on drug discovery, drug development and drug delivery within the existing flexibilities of the current regulatory and legislative framework (8-page / 1.2MB PDF). These new accelerated access frameworks could also lead to a re-appreciation of development risk by potential investors and licensees in life sciences technology where they could see earlier marketing potential, the paper said.
Opinion on the merits of the Bill was divided between the Lords that spoke on the issue on Friday. Lord Saatchi said that the Bill would encourage medical practitioners "to seek improvement to the standard procedure" and prescribe alternative treatments for conditions "in a safe and responsible way". He said that the 'standard procedure' doctors often follow when administering treatments may not necessarily deliver the best patient outcomes.
Lord Saatchi expressed concern about the rising culture of litigation in the health sector which he said may dissuade doctors from experimenting responsibly with new treatments. His view was supported by Lord Howard of Rising who challenged claims by other peers that existing legislation was sufficient to support medical innovation.
"It is possible, as has been claimed, to innovate under the law as it exists today but, as has been pointed out, we live in a litigious society," Lord Howard said. "The law as it stands does not do enough for a doctor who wishes to administer an innovative treatment that may give the last chance of a cure to a dying patient; indeed, there is a bias towards no action. The Bill will help to remove doubt about a doctor’s ability to act in what he and his patient believe to be the patient’s best interest."
"It would be far better for a doctor’s energy and concerns to be focused on the patient’s health rather than worrying about their own position if he or she were to take innovative steps to save a patient’s life. There should not be a bias against the ability to give a potentially life-saving treatment to save a dying patient," he said.
However, other peers questioned whether the new laws were necessary. Lord Colwyn said that improved innovation in medical treatments could be achieved by issuing doctors with new guidelines rather than setting new laws. Lord Turnberg questioned whether doctors' decision making was being inhibited by a threat of potential litigation, although Lord Woolf said that it was "nonsense to suggest that the culture of litigation that now exists does not have a dampening effect on doctors".
Baroness Masham of Ilton expressed concern about whether patients would lose certain rights to redress should treatments be administered in accordance with the Bill.
"The Bill will remove a layer of protection and redress for vulnerable patients who are harmed when their doctors act in a way which no other doctor would support." She said it would "encourage unsafe and unaccountable practice by doctors"
"[Action Against Medical Accidents] (AvMA) is concerned that patients should be afforded protection against irresponsible or negligent doctors," Baroness Masham said, "Regrettably, the Bill does not provide adequate protection and could actually encourage unsafe practices... AvMA is also concerned that patients who agree to treatment that goes beyond the bounds of what is considered acceptable by all responsible bodies of medical opinion are precisely those who require particular protection. The desperate patient who will try anything to be cured or to secure a short extension of their life may be the most vulnerable to exploitation."
"Further clarity is needed on how the Medical Innovation Bill will give priority to informed consent and peer review in order to protect patient safety. Safeguards are needed against unintended consequences such as encouraging reckless innovation and exacerbating the postcode lottery of services," she said.
Labour peer Lord Brennan said the main risk stemming from the Bill was that it could give doctors too much freedom.
"The risk is obvious," he said. "Some practitioners, small groups in a private practice, or the private sector of a medical practice will know that they are going to be legally immune, or will feel confident that they are, and will take advantage of this. It is self-evident. We know, historically, how vulnerable patients will do anything; even with pretty average clinicians, when they have no great confidence in them, some people will do anything in medical terms. That is a danger, and this Bill does not embrace sufficient protections to meet that danger."