Medical Innovation Bill [HL]

Lord Ribeiro Excerpts

Friday 27th June 2014 Lords Chamber

[Lord Ribeiro (Con)]

My Lords, I am pleased to follow the noble Lord, Lord Winston, who is an acknowledged innovator outwith the accepted norm. I welcome the introduction of this Bill, which has generated much interest and debate following the recent NHS consultation—based, I might add, on an earlier iteration of the Bill. The Bill we are discussing today is simple and easy to implement, if confined to hospital practice involving surgery and interventional procedures. The terms “treatments” in Clause 1(3)(e) and “treatment” in Clause 1(4)(b) open this up to all treatments provided, whether in the regulated area of the NHS and private hospitals or the unregulated area of the cosmetic industry, where unqualified practitioners may undertake Botox treatments for cosmetic purposes.

During the early stages of the Bill I met my noble friend Lord Saatchi with colleagues from the Pelican Cancer Foundation, a cancer charity, to explain some of the barriers to innovation that we had experienced. These have been mirrored by Sir Robert Francis and were identified earlier by the noble Baroness, Lady Bakewell: bureaucracy, scarcity of resources and ethical reservations. We stressed the importance of keeping patients at the centre of the decision-making process and providing them with as much information as possible on, for example, the number of patients who had previously received the procedure or treatment; the percentage cure rate of the treatment; the likely impact of side effects and an obligation to explain the impact of those side effects to the patients. These are all encapsulated in Clause 1(3)(c) and (e). The Medical Defence Union and others feel that Clause 1(3)(e) is unnecessary, given the current use of Clause 1(3)(d), which deals with informed consent.

Informed consent is even more important when dealing with new and untried techniques. The practice of medicine is regulated through numerous guidelines, guidance, protocols and pathways which must be followed to ensure the safe delivery of care. Many of these did not exist when I began my surgical career and I was free to innovate in the best interests of my patients, usually after joint consultation and agreement. This is not the case for surgeons today. The advent of laparoscopic cholecystectomy, or keyhole removal of the gall bladder, is a case in point. In 1989, a French gynaecologist removed the gall bladder of a patient while carrying out a routine gynaecological operation. As we heard earlier, gynaecologists have been rummaging around in the stomach with their little telescopes for an awfully long time. This ushered in a new era of surgery, which challenged the gold standard of open surgery for gallstones that had held for 100 years.

However, the freedom to undertake such operations without any oversight came at a price to some of the patients involved, who developed unnecessary complications. At the time, I set up a national register to collect data on laparoscopic cholecystectomy, from which we published reports of complications to warn colleagues of the hazards of these new procedures. It is an innovation which would be impossible to introduce today and many of us would be considered mavericks for carrying it out.

The Royal College of Surgeons and the Government established a minimal access training unit to teach the new procedure and, in 1996, introduced a safety and efficacy register for new interventional procedures, called SERNIP. The register accumulated a list of new procedures and allocated each to a category, signifying its perceived degree of safety and efficacy, but it had no legal power and so its effects were limited. It was taken up by NICE in 2002 and remains within its remit. If the Bill is adopted, it would be essential to have a national register with legal powers to log and follow up with patients. I am delighted to hear that Oxford University has agreed to undertake this.

One way to ensure the Bill’s stated aim—that it,

“allows the test of whether innovation is negligent to be applied at the time when the doctor is deciding to innovate”,—

is to provide access to expert independent advice, particularly when the multidisciplinary team or the body of one’s peers fails to sanction the procedure being proposed. The invited review mechanism deployed by the Royal College of Surgeons to assess failing surgical departments in the NHS at the request of a trust board could act as a blueprint for such independent advice, providing two experts from relevant specialties to review the case for innovation, one from the Royal College and the other from the specialty association or society. This is no different from requesting a second opinion—something we all find valuable and which reassures patients that a body of opinion agrees with your proposals for treatment. The situation becomes more complicated, however, when the practitioner does not have a responsible officer, an MDT, a clinical director, a medical director or a chief executive to consult and, as in the case of the NHS, to approve the introduction of a new technique or procedure.

The overarching umbrella of protection—some may say “bureaucracy”—is not available to non-NHS practitioners, some of whom are not medically qualified but undertake cosmetic procedures in the private sector. Some, for financial gain, may work out of their own clinics or hospitals. How can we ensure that the treatment they provide is covered by the Bill? Will they also be free to innovate? The answer is yes, because they do already. Some end up creating problems and facing negligence charges, but they would not enjoy the protection that the Bill provides. This is something that we must look at carefully. When we talk about cancer, it is very easy to talk about innovation and freeing people from the shackles that bureaucracy provides because we all want the best for our patients, particularly when we are dealing with cancer. However, the use of the term “treatment” opens up the Bill to a wide area that will need to be covered. That is the only area that I have reservations about; otherwise, I am in support.