Draft Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) Order 2016

George Freeman Excerpts

Monday 25th April 2016 General Committees

[The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)]

I beg to move,

That the Committee has considered the draft Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) Order 2016.

This technical amendment allows the Medicines and Healthcare Products Regulatory Agency to fund its work on e-cigarettes through fee income. The implementation of the tobacco products directive and the specific fee regime to cover regulatory activity undertaken by the MHRA are covered in separate legislation that has been laid before Parliament. The order affects only the MHRA, as it changes very slightly the terms on which the MHRA operates as a trading fund. As an accounting change, it is debated in the House of Commons, but not the House of Lords.

As I said, the fees themselves are the subject of separate legislation. However, the proposed fee levels for the coming year are £150 to notify a new product, £80 to notify a substantial modification to an existing product and a £60 annual fee per notified product starting from 1 April 2017. The fees are set at a level that will enable the MHRA to recover the cost of reviewing information on new products notified through the EU portal and of carrying out subsequent publishing and monitoring work. The fee levels will be reviewed during the first year and regularly thereafter in consultation with the e-cigarette industry, health advisory bodies and the public to ensure that they remain a proportionate and fair recovery of the cost of undertaking that work.

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[George Freeman]

I thank the hon. Member for Ellesmere Port and Neston and the Opposition for their support for the measure, which I expected but which is none the less welcome. It is a sensible piece of legislation, and I am grateful for their support. I will answer the hon. Gentleman’s three questions, as well as those of the hon. Member for Newport West.

On terminology, the hon. Member for Ellesmere Port and Neston makes an important point. I am conscious of the need to keep well aligned the devolved Assemblies’ different work in this space. As the UK Minister for Life Sciences, I am conscious that the devolved Governments have their own responsibilities, and I have initiated an annual meeting with Ministers from the devolved Administrations to consider the sector. I will table the measure there and raise the point that he has made. I am not aware that it is a problem at the moment, but I think that his point was more about ensuring that it does not become one.

The hon. Gentleman asked about effectiveness. We intend, as part of our more general work on monitoring the effectiveness of the various campaigns against smoking, to ensure that the measure does not have any counter-effect. The Under-Secretary of State for Health, my hon. Friend the Member for Battersea (Jane Ellison), who has responsibility for public health, will lead on that, alongside her work on smoking more generally.

On the hon. Gentleman’s third question, I do not fear that the measure might normalise smoking. The evidence that we have received is that it should not, and there is no reason to expect that it will. I agree that we want to ensure that that does not happen.

The charges are not enormous, and they are perfectly in accord with charges across the rest of the medical device sector. For those who wonder what the statutory instrument is all about, it is about ensuring that vaping devices, which contain chemicals and a filament that vaporises liquid to create an inhalant, are properly regulated and monitored, and that the chemical inside is correct.

The hon. Member for Newport West asked whether I am concerned about the danger of the MHRA being distorted by commercial interests. I am not. I am not complacent about it, but wherever I go—in this country, in Europe or around the world—the MHRA is held up as an example of Britain at its absolute best. It is rigorous, it is science and evidence-based, and it is leading the debate on the regulation of 21st-century devices, drugs and diagnostics. In doing that, it is important that it is able to draw on the industry and best practice within it, but, as the Minister with responsibility for the MHRA, I assure Members that in its annual reviews, in my visits and in all my work with it, I see no evidence of undue leniency—if that is the word—with the industry. What I see is an organisation that is committed to regulating in a way that not only ensures that patient safety is paramount, but that helps the industry, on which we all rely for these drugs, devices and diagnostics, to bring them to market. I hope that it is not hostile to industry, but that it is, first and foremost—as, indeed, it is—completely committed to the rigorous implementation of the highest standards of patient safety.

I commend the statutory instrument to the Committee.

Question put and agreed to.