The medical innovation bill seeks to save lives. In fact it will endanger them

http://www.theguardian.com/commentisfree/2015/oct/14/medical-innovation-bill-saves-lives-endanger

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Any medical innovation that saves lives and provides better outcomes for patients has to be a good thing. But a private member’s bill which goes before the Commons on Friday and which purports to make it easier to save lives is an ill-judged, dangerous and unnecessary attempt at legislation in this area.

The basic tenet of the access to medical treatments (innovation) bill is that doctors should be able to try untested drugs and treatments on patients without the fear of medical negligence claims. This fear of litigation, it is argued, stifles innovation, although neither the bill’s author, Conservative MP Chris Heaton-Harris, nor his backers seem able to provide any real evidence to support this claim.

Related: ‘Quack’s charter’ warning over bill on untested medicines

By contrast Sarah Wollaston, the MP for Totnes and chair of the health select committee, has said the bill should be renamed the “medical anecdote bill” because it would allow unconnected treatments based on anecdotal evidence while removing protection for patients.

Yet the bill is modelled on similar legislation proposed in the House of Lords by Lord Saatchi, which was vetoed in February by Norman Lamb, then the Liberal Democrat health minister. If the new bill secures government support it could become law.

But this would move medicine into treacherous territory. Key principles of healthcare including responsibility, accountability, understanding and outcomes would become blurred. While Heaton-Harris has sought to address concerns expressed by a broad swath of professional opinion – including the BMA, Royal College of Surgeons and NHS Litigation Authority – the result is muddled and in parts contradictory.

Its starting point is that “it is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition if the decision to do so is taken responsibly”. Going on to define “responsibly”, it says that a doctor should obtain and consider “the views of one or more appropriately qualified doctors in relation to the proposed treatment”.

While the doctor needs to obtain lawful consent before carrying out treatments, the following clause in the bill merely requires the doctor to “consider any opinions or requests by the patient”. But which is it to be: lawful consent or taking the patient’s opinion into consideration?

A recent decision of the supreme court (in Montgomery v Lanarkshire Health Board) made it clear that treatment decisions are made by patients, not doctors. “The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment and of any reasonable alternative or variant treatments,” it concluded.

Related: Lib Dems veto Saatchi's medical innovation bill

It is imperative that patients are involved in the decision-making process and are fully informed of any risks and benefits of a treatment. And it is vital that the safety and dignity of every patient is assured. This is particularly important when decisions are likely to affect them at their most vulnerable – possibly when facing death.

The bill is based on a misunderstanding of the current law,(based on rulings in Bolitho v City and Hackney Health Authority), which already permits innovation while protecting the interests of both patients and doctors. It would not benefit doctors because the meaning of the proposed legislation is not clear, so they might come under pressure from patients desperate to “try anything”. It most certainly would not benefit patients or their families because it would remove existing safeguards that protect them and entitle them to compensation if they suffer from actions that would currently be classed as negligent.

A bill which claims to be about medical innovation – and which would enact a position already overtaken by current case law – is in fact an attempt to narrow patient rights to recover damages for negligence. This would ultimately reassert the primacy of clinical decision making over an individual’s right to give consent, an approach comprehensively criticised in the case of Montgomery as “paternalistic”.

Safety and protection for patients should be paramount when they are offered untried treatments. Only by having a public debate can the views of all interested parties including patients, healthcare professionals and pharmaceutical companies be taken into account. This bill should not become law until that public debate has been allowed to take place.