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Department of Health

Medical Innovation Bill: Will it encourage responsible innovation and help prevent what's irresponsible? Please give us your views

What should the bill say?

Have you read ‘Is there a problem?’

The purpose of the Bill (see clause 1(1)) is to encourage responsible innovation in medical treatment, and help prevent innovation that isn’t responsible.

Clause 1(2) says that it is not negligent for a doctor not to use standard treatments for a condition if they take the decision ‘responsibly’. What counts as ‘a responsible decision’ is made clear later in the Bill.

Clause 1(3) makes clear that the Bill applies in just two situations, not in all the situations where medical innovation might take place. The first is where, in the doctor’s opinion, it is unclear if the treatment they are proposing would have the support of a responsible body of medical opinion if the case came to court. The second is where, in the doctor’s opinion, the treatment wouldn’t have such support if the case came to court.

Question 3: Do you agree with the circumstances in which the Bill applies, as outlined in clause 1(3)? If not, please identify any changes you suggest, and give your reasons for them.

If a doctor decides to carry out innovative treatment and wants this decision to be considered ‘responsible’, the decision must be based on the points listed in clause 1(4) and clause 1(5). We welcome suggestions for refining this list.

Question 4: Do you have any comments on the matters listed in clause 1(4)-(5) on which the doctor’s decision must be based for it to be responsible? Are there any that should be removed, or changed, or added, and if so why?

For example, should the Bill spell out that the other treatments mentioned in clause 1(5) (a-c) include treatments offered as part of research studies?

For a decision to carry out innovative treatment to be ‘responsible’, it needs to be based on the points listed in clause 1(4)-(5) and also to be made in accordance with a proper process. Clause 1(6) defines a ‘proper process’ as one that must:

  • be accountable
  • be transparent
  • allow full consideration by the doctor of all relevant matters.

Clause 1(7) helps clarify what this process might look like. It draws attention to the importance of:

  • discussing the treatment with the patient
  • taking the decision within a multi-disciplinary team
  • notifying the doctor’s responsible officer (the person responsible for notifying the General Medical Council of the doctor’s fitness to practice).

It won’t always be possible for a process to include the 3 elements listed in clause 1(7). For example:

  • a doctor working in private practice might not have a ‘responsible officer’

This is why clause 1(7) doesn’t say these steps must be taken. But, a doctor would be expected to have good reason for not taking any of these steps where it was possible to do so.

We welcome suggestions for refining the process described in clauses 1(6) and clause 1(7).

Question 5: Do you have any comments on the process set out in clause 1(6)-(7)? Are there any provisions that should be removed, changed or added, and if so, why?

The Bill, see clause 1(8), doesn’t change the laws around:

  • consent
  • research
  • what’s in a patient’s best interests

This means important safeguards remain in place.

Please now take a look at ‘Having an impact’