1: Clause 9, page 7, line 38, leave out “UK health service products” and insert “a particular UK health service product”
My Lords, there are two sets of amendments within this grouping. The first comprises small amendments relating to the circumstances in which the Government would be required to provide producers with an information notice. The second relates to the arrangements required for implementation of the legislation in Northern Ireland.
I turn, first, to Amendments 1 and 2. Amendment 1 clarifies that an information notice is required in respect of the costs incurred by a company in connection with the manufacturing, distribution or supply of a particular UK health service product. Amendment 2 is a technical drafting change to further clarify the intent of this clause and the type of transaction being contemplated.
On Report, I tabled amendments to the information requirements that would necessitate the Government issuing an information notice if they wanted UK producers to provide certain cost and profit information. This was in response to reasonable concerns raised by several noble Lords that attributing costs and profits to individual products, as opposed to simple aggregate-level data, would be burdensome for companies. The amendments that I have brought forward today reinforce these information notice procedures by clarifying that they apply to cost and profit information relating to individual products but not to aggregate-level data across a portfolio of products supplied by a company to the health service.
As I explained on Report, we already collect cost, sales and profit information on an annual basis under our voluntary scheme, the PPRS. This information is supplied at an aggregate level across a range of branded medicines supplied by a company to the health service. Clearly we need to be able to continue to collect these data in a routine way in order to maintain the voluntary scheme, and indeed to collect a similar type of routine aggregate-level company information in any future statutory scheme.
These amendments enable us to continue with the current approach to collecting company-level data in a non-bureaucratic way while, critically, ensuring that the information notice procedure, which was a concern of noble Lords, is focused on the area which we know is the greatest burden to companies—providing cost information on a product-by-product basis. I am pleased to say that my officials have discussed these amendments with the ABPI, the trade body for the pharmaceutical industry, which is content that they address industry concerns.
I now turn to Amendments 3, 4, 5 and 6. As noble Lords know, most of the Bill extends to England, Scotland, Wales and Northern Ireland, with some elements extending only to England and Wales or only to Scotland. A legislative consent Motion is required from Scotland, Wales and Northern Ireland for the matters in the Bill that are devolved.
I am bringing forward these technical amendments to address the fact that the Northern Ireland Assembly was not able to complete the passage of its legislative consent Motion on the Bill before it dissolved, although significant progress had been made, with the relevant committee having given approval. Our amendments therefore seek to change the Bill to enable the Northern Ireland components to be commenced separately through regulations. These components of the Bill will be commenced only after legislative consent has been secured.
My Lords, I do not propose to detain the House. I merely wish to thank my noble friend the Minister for the further clarification that Amendments 1 and 2, in particular, give to Clause 9.
I was among those who raised a concern. Although the industry completely understood that in order to make the PPRS effective there was a requirement for a scheme for the acquisition of data in aggregate, as my noble friend described, the powers would have enabled there to be a lot of demands for information which went beyond what had previously been required and which had the potential to be very intrusive. Under those circumstances, an information notice system, with proper details supplied to companies and with a potential appeal right, was required. We discussed that and I am very grateful to the Minister for taking it on board and putting in place something which I think will give considerable reassurance to the industry that the scheme will not be as burdensome as it could have been.
My Lords, we on these Benches are also happy to support the amendments. Like the noble Lord, Lord Lansley, I have no intention of detaining the House with long-winded thanks. However, I want to voice my recognition that the Minister, in his new role, has both understood and responded to the issues raised on the Opposition and Cross Benches about the shortcomings of the Bill, which had been through the House of Commons without anybody noticing or trying to amend its unintended consequences, rather like the Article 50 Bill that we debated in this House on Monday and Tuesday.
My Lords, I thank the Minister for listening so intently during the proceedings and for his response. I am also grateful to those on the Front Benches opposite for their co-operative approach—they are a shining example to their colleagues in the Commons of how to be effective in persuading the Government to change their mind. I hope the Minister’s emollient approach will continue when the Bill leaves this place in relation to the new clause that we have put in at the front of the Bill, despite the advice he was given. I hope that good will will continue to operate as the Bill completes its passage through both Houses of Parliament.
My Lords, I too welcome the amendments. Clearly, the Opposition will support them. I must remind the House of my presidency of the Health Care Supply Association and GS1 UK.
First, I thank the Minister and his officials for their warm co-operation. The ability to have a number of meetings has been much appreciated. This has been a very good example of cross-House co-operation. Various noble Lords, including the noble Lord, Lord Warner, and the noble Baroness, Lady Walmsley, worked very hard together on the core issue of ensuring that NHS patients get access to effective new medicines. I say to the Minister that I hope Clause 3 will remain in the Bill when it comes back to your Lordships’ House, if indeed it needs to come back—I take the point of the noble Baroness, Lady Walmsley, that this House has done the job it is here to do: it has revised and scrutinised the legislation. I would have thought that the other place should simply accept the Bill as it is, and I hope the Minister will be able to confirm that when he responds. I also thank my noble friend Lady Wheeler for her tremendous support, and Dan Stevens, our health researcher.
It seems to me that the Minister has shown himself adept at handling health legislation in your Lordships’ House, and so we look forward to the next health Bill. If he is looking for suggestions, we are going to have the great repeal Bill and perhaps we can look forward also to the repeal of the Health and Social Care Act 2012. That would bring great joy to many.
I am very grateful to noble Lords for their support for these amendments. I am also grateful to my noble friend Lord Lansley, one of the architects of this new approach to information notices; that was extremely useful and we have ended up in a good place. I am grateful to the noble Baroness, Lady Walmsley, who I have enjoyed getting to know through the process of this Bill. She is quite right to emphasise the vital role that this House plays through its proper constitutional role in revising legislation—I will not say anything more than that. I thank the noble Lords, Lord Warner and Lord Hunt, both of whom have been in my shoes in the past. Good will will certainly operate, and I hope that both noble Lords, and indeed the noble Baroness, Lady Wheeler, have found me to be open, open-minded and willing to work with them. Throughout the passage of the Bill I have been keen to ensure that it is a proportionate response to tackle this challenge, and I think we are all agreed on that.
To conclude, I am delighted that we have come this far on the scrutiny of the Bill and are now debating the final amendments to bring it to a close. As we end Third Reading I would like to take this opportunity to place on record my thanks to all noble Lords who have taken part in the debates, beyond those I mentioned just now, throughout all stages in this House. It is fair to say that the collected efforts of this House in bringing together different views have paid dividends in the improvements that we have seen. It has been a good example of the rigour and attention to detail that this House is known for.
I particularly thank the many officials involved in the Bill, who have worked not only to support me but to ensure that noble Lords are briefed and that any concerns are addressed, within what at times have been very tight timescales. They have done a tremendous job and I am sure the House will join me in paying tribute to them.
Although this may not be the final word on the Bill, I am convinced that the House is sending it back to the other place having been significantly improved in key respects.
Amendment 1 agreed.
2: Clause 9, page 7, line 39, leave out from “transaction” to end of line 40 and insert “between the producer and a UK producer for that product)”
Amendment 2 agreed.
Clause 13: Commencement
Amendments 3 to 6
3: Clause 13, page 14, line 34, after “10” insert “and 11(19)”
4: Clause 13, page 14, line 38, leave out “make”
5: Clause 13, page 14, line 39, leave out paragraph (a) and insert—
“( ) appoint different days, or make different provision, for different purposes or areas, and”
6: Clause 13, page 15, line 1, at beginning insert “make”
Amendments 3 to 6 agreed.
Bill passed and sent to the Commons.