Clause 2 - Database of innovative treatments

Part of Access to Medical Treatments (Innovation) Bill – in a Public Bill Committee at 3:15 pm on 16 December 2015.

Alert me about debates like this

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health 3:15, 16 December 2015

I will be brief. Following our earlier conversation about the database provisions, I emphasise that they are the part of the Bill that the Government most strongly support. The database is not envisaged as it was in the predecessor Bill—if I may call it that—as a registry for recording ad hoc innovations by clinicians, but as a fundamental database to give all clinicians access to information on innovative medicines, including off-label uses of medicines and medicines that are either unlicensed but in use, as in the early access to medicines scheme, or in clinical trials, in which a patient might be eligible to enrol. The Clause gives the Secretary of State the power to make regulations conferring functions on the HSCIC, the body that develops and puts into place databases such as the one we are discussing, in connection with the establishment, maintenance and operation of the database for innovative medical treatments.

I am pleased that my hon. Friend the Member for Daventry proposed the database for recording such treatments and for getting information on them out to clinicians. The measure is important in the promotion of innovation. Crucially, the measure would give doctors the ability to search the database for innovations, so the position is very different from that under the Bill introduced in the House of Lords last year, which proposed a database as a registry on which innovative doctors could log what they had done. The database proposed in this Bill is completely different, which is why I strongly support it.

The database could result in better care and health outcomes for patients and a faster uptake of new treatments, and it could support our work to make Britain a world-leading centre for innovative medicines. The pace of progress in genomics and informatics is profoundly changing the way in which new drugs are developed, but our databases and systems information have not kept up, so that is among the things that are being considered under the accelerated access review. While the Secretary of State might already have the legal power to create a database, the Bill helpfully sets out that provision may be made to give instructions to HSCIC to create a specific database, which I would welcome. If the Bill does not, for whatever reason, reach the statute book, I would happily proceed towards establishing such a database, but it would be helpful if the provision were set out clearly in legislation.

The Government do not support Amendment 5 because it is not exhaustive. Although it represents a helpful list of consultees, such a provision would need to include many more organisations. While I understand the intention behind the amendment, restricting the process would not be helpful, but I would be happy to write to members of the Committee about our approach. I undertake to write to all the relevant organisations and to ensure that they are consulted, but I am old enough and ugly enough to know that well-intentioned lists of statutory consultees can quickly become out of date. They can create weird anomalies whereby parties that really have nothing to say are statutory consultees, yet those who have a lot to say are not. I am happy to discuss what other steps we can take to ensure that those who, rightly, need to be informed about the Bill and the mechanisms it proposes are properly informed.

The Government do not support amendment 6 for the same reason—because the list is not exhaustive—but I will be happy to put in a place an alternative mechanism to ensure that those parties listed the amendment and others are properly informed. I would not want to put in law a list of consultees that we might well need to amend quite quickly. I, for one, do not want to find myself back in Committee considering a statutory instrument to amend a list of statutory consultees established by a well-intentioned proposal, so I hope that the hon. Member for Ellesmere Port and Neston will withdraw the amendment.

Clause

A parliamentary bill is divided into sections called clauses.

Printed in the margin next to each clause is a brief explanatory `side-note' giving details of what the effect of the clause will be.

During the committee stage of a bill, MPs examine these clauses in detail and may introduce new clauses of their own or table amendments to the existing clauses.

When a bill becomes an Act of Parliament, clauses become known as sections.

House of Lords

The house of Lords is the upper chamber of the Houses of Parliament. It is filled with Lords (I.E. Lords, Dukes, Baron/esses, Earls, Marquis/esses, Viscounts, Count/esses, etc.) The Lords consider proposals from the EU or from the commons. They can then reject a bill, accept it, or make amendments. If a bill is rejected, the commons can send it back to the lords for re-discussion. The Lords cannot stop a bill for longer than one parliamentary session. If a bill is accepted, it is forwarded to the Queen, who will then sign it and make it law. If a bill is amended, the amended bill is sent back to the House of Commons for discussion.

The Lords are not elected; they are appointed. Lords can take a "whip", that is to say, they can choose a party to represent. Currently, most Peers are Conservative.

Secretary of State

Secretary of State was originally the title given to the two officials who conducted the Royal Correspondence under Elizabeth I. Now it is the title held by some of the more important Government Ministers, for example the Secretary of State for Foreign Affairs.

amendment

As a bill passes through Parliament, MPs and peers may suggest amendments - or changes - which they believe will improve the quality of the legislation.

Many hundreds of amendments are proposed by members to major bills as they pass through committee stage, report stage and third reading in both Houses of Parliament.

In the end only a handful of amendments will be incorporated into any bill.

The Speaker - or the chairman in the case of standing committees - has the power to select which amendments should be debated.

clause

A parliamentary bill is divided into sections called clauses.

Printed in the margin next to each clause is a brief explanatory `side-note' giving details of what the effect of the clause will be.

During the committee stage of a bill, MPs examine these clauses in detail and may introduce new clauses of their own or table amendments to the existing clauses.

When a bill becomes an Act of Parliament, clauses become known as sections.