Patents (Amendment) (EU Exit) Regulations 2018

Debate between Lord Warner and Lord Clement-Jones

Wednesday 6th February 2019 Lords Chamber

[Lord Warner (CB)]

My Lords, I raised several concerns about this SI in Grand Committee, as the Minister recognised. As he knows, these were the result of briefings from the BIA and the ABPI, with which I am glad to say he has had further meetings. However, since his meetings both these organisations have provided me with further briefing about their continuing concerns.

Before turning to these concerns, I will briefly place them in the wider context of the damage done by Brexit—and the Government’s conduct of it—to our highly successful life sciences industry. This damage could make Nissan and Sunderland look like small beer if we are not careful. From the Prime Minister down, the Government have shown a poor appreciation of the damage being done to this sector: the loss of the EU medicines regulator from the UK; the loss of investment opportunities in the UK; the missed opportunities for collaborative international joint research, development projects and clinical trials; the drain from the UK of talented overseas scientists; and the likely loss of a growing amount of our own homegrown scientific talent.

To this litany of casual vandalism the Government have now added a statutory instrument which, if it were used in the case of our exiting the EU with no deal, would reduce the protection of exclusive intellectual property. The problem is caused by the SI’s approach to supplementary protection certificates—SPCs—which are a key part of the intellectual property protection framework for pharmaceutical research. SPCs are intended to give a period of exclusivity from inherent risks in the development of new pharmaceutical products. But the industry’s trade bodies—both the BIA and the ABPI—are convinced that, in the real world that they occupy, the SPCs as structured in this SI are fundamentally flawed.

In their view—the exact opposite of the Minister’s—this flaw reduces the period of exclusivity for drugs authorised in the UK, because the start of the period for exclusivity in the UK is backdated to a drug’s earlier authorisation in the EU. They are losing a bit of their exclusivity period. The chief executive of the ABPI put this extremely well:

“Britain is internationally renowned for its strong IP framework and this has made it an attractive home for investment from all industrial sectors, including pharmaceuticals. We’re concerned that these measures are a step backwards and seriously undermine the strong life sciences sector that we’ve worked so hard to build over the past 70 years”.


These views are shared by the BIA.

The problem has arisen in large part from the Government’s failure to consult properly on these regulations at the outset—as has been shown to be the case in other no-deal SIs, as we have already discussed. I drew the Minister’s attention in Grand Committee to the inadequacies of that consultation process, and I am pleased to see that he seems to have accepted some of that and tried to rectify matters through proper discussion with the ABPI and the BIA. I congratulate him on taking that particular initiative.

I think that the Minister will be pleased to know that I do not intend to bang on further about past misdemeanours. Instead, I ask him to give the industry two clear-cut assurances about the future conduct of the Government. First, I would like to hear it from him, on the record, that the Government recommit to the UK’s status as a world leader in safeguarding intellectual property and commit to make no further erosions of the UK intellectual property framework; and, secondly, that the Government commit to a specific review of the intellectual property legislation being introduced through statutory instruments as part of the no-deal Brexit planning. The reason for that second one is, frankly, that the industry is very sceptical about whether the Government will just drop these proposals if there is a deal. Ministers in the Government need to understand that they have lost a lot of the confidence of this sector. The time has come for them to start to rebuild that confidence in an industry which is vital for this country’s future.

[Lord Clement-Jones (LD)]

My Lords, the noble Lord, Lord Warner, has expressed the impact on the life sciences industry extremely effectively and eloquently, and I do not wish to repeat anything of what he said. Quite apart from the damning quote from the chief executive, Mike Thompson, the key sentence that I saw in the ABPI’s briefing was:

“The signal the Government has sent to global pharmaceutical companies large and small is that the UK will be less committed to IP protection after Brexit than it has been to date”.


For a major industry to consider that seems extremely damning.

As the noble Lord, Lord Warner, pointed out, the Minister said that it is correct to raise these issues and he is keen to start exploring them, so there is some intention now to have some consultation post the SI rather than proper consultation before it. I think we are looking forward to hearing a bit more of a concrete proposal from the Minister with regard to what precisely is planned.

The Minister’s six and a half-page letter, as we must now call it, dealt with the question of participation in the unified patent court, as set out in the White Paper last autumn. I made the point in Committee that if the UP convention is ratified by Germany and comes into force ahead of our exit date, the UK will need to work out how to remain a member of the UPC or withdraw from the systems, which could have significant impacts on business. In that context, I questioned in Committee whether the UK will have to acknowledge the supremacy of EU law and the ECJ as part of the signing up process. In his letter, the Minister advises that,

“when ruling on domestic cases, UK courts will not be bound to follow decisions of the UPC, or rulings of the European Court of Justice applied by the UPC”.

The last time we discussed this SI, I brandished a 39-page opinion on the subject, so I am rather baffled by the advice that the IPO and the Minister have received in those circumstances, if we have signed up to the unified patent court agreement. I would very much like to hear a bit more clarification on that subject from the Minister.

Patents (Amendment) (EU Exit) Regulations 2018

Debate between Lord Warner and Lord Clement-Jones

Monday 14th January 2019 Grand Committee

[Lord Clement-Jones (LD)]

My Lords, we have to conclude after the debate so far that this SI is holed below the waterline and the Minister will have some difficulty in preventing it sinking. He will have to write a pretty good letter by the time this comes to the whole House to see that it goes through when it comes to a vote there. The powerful speech made by the noble Lord, Lord Warner, has exposed the business issues involved in this. I was interested to hear what the noble Lord, Lord Adonis, said about the legal technicalities on this, and of course the impeccable logic of the noble Lord, Lord Deben, and the noble Baroness, Lady Kingsmill, on the consultation and the impact assessment is unassailable. The Minister will therefore have a great deal of difficulty in persuading us to approve these regulations, whether here or, eventually, in the House.

I am grateful to my noble friend who is a patent expert. My expertise in intellectual property extends to trademarks and copyright but it is very useful to have her unpacking of some of these issues as well. What particularly concerns me about the substance of the SI is not just that it is in the eventuality of no deal but that it has all the signs of something that was planned to take effect at the end of the transition period if the Prime Minister’s deal was going to take effect. This looks as if it is a longer-term arrangement. I think it was enshrined in the White Paper, or at least the outlines of it were, and that makes it of particular significance to get right. If there is any kind of deal then I suspect that this is what will be put into effect. It therefore has a double significance and is not just a fix for this purpose which has not been consulted over and which is not acceptable to a major trade body. I have dealt with the BioIndustry Association and I have a great deal of time for it and respect for the expertise that it embodies. The fact that there has not been adequate consultation over something that is potentially a long-term solution makes this even more questionable.

[Lord Warner]

I am sorry to interrupt the noble Lord further but I want to give a bit of support to what he is saying. In my remarks I drew attention to the fact that the MHRA, the UK pharmaceutical regulator, actually tried to suggest to the BIA that it should wait for a review in two years’ time. That looks remarkably like the timetable for the end of the transition period, so I want to give some support to the arguments that the noble Lord is making.

[Lord Clement-Jones]

I thank the noble Lord for that intervention because that is exactly the impression that I had got.

To add to the Minister’s woes, I want to go off into a completely different subject that he himself raised at the very beginning: the issue of the Agreement on a Unified Patent Court and the unified patent. The unified patent has come up; the Minister has mentioned it and it was included in the technical note in September. There is a big issue surrounding the Agreement on a Unified Patent Court and the unified patent. If the agreement is ratified by Germany and comes into force ahead of any exit date, the UK will need to work out how to remain a member of the UPC or withdraw from the system, which could have a significant impact on business. Of course, at this stage it is not clear if the agreement will come into effect at all, but if it does and if, as a third-party country, the UK then wants to take part, is it not clear—I have a 39-page legal opinion on this subject—that we, the UK, will have to acknowledge the supremacy of EU law and the ECJ as part of signing up to the UPC agreement? What kind of “taking back control” for Brexiters will that be?

What advice have the Government received on this matter? I heard what the Minister had to say: he made the very positive statement that we were going to sign up. Have the Government had any further observations on the UPC agreement and the unified patent? How do they envisage UK legislation dovetailing with both systems, assuming that it is ratified?

European Union (Withdrawal) Bill

Debate between Lord Warner and Lord Clement-Jones

Committee: 6th sitting (Hansard): House of Lords
Monday 12th March 2018 Lords Chamber

[Lord Warner]

My Lords, I have added my name to the amendments and agree entirely with what the noble Lord, Lord Stevenson, said. I do not intend to traverse the same ground as him and may not be quite as helpful to the Prime Minister as he has been.

I want to add a dimension on data protection from the perspective of someone who has been a Minister and a senior civil servant. It is very easy for even the most well-intentioned Minister to overlook the importance of data protection and privacy to some of our fellow citizens when we are trying to push through what is seen as a measure of great collective benefit. We have seen how easy it is for free-speech arguments to trump individual privacy considerations. In the rush to secure medical advances through research, it is easy to see people who are nervous of giving their medical history to a researcher they do not know as Luddites to be overruled. That is why the Data Protection Act 1998 was a landmark Act. It calls on bureaucracies to stop and think and to become more thoughtful about citizens’ rights to privacy and individual data protection. Since that Act, case law has extended those protections in many cases. We do not want any backsliding, and there are plenty of powerful interests who would backslide if these legal protections were diminished. It is for similar reasons that the successor to the 1998 Act needs to be fully protected following our departure from the EU, and that protection needs to be set out clearly in this Bill. This is even more the case given that the Government have set their face against protecting the transfer into UK law of the Charter of Fundamental Rights, which contains privacy provisions.

As I said on an earlier amendment on clinical trials, we need overtly to protect existing rights and provisions important to our fellow citizens from casual vandalism later. That means being sceptical about assurances from Ministers, even the Prime Minister, in relation to this Bill and relying on future actions to preserve safeguards. We have to put more guarantees in the Bill before it leaves this House, as I said on Amendment 84. I want before I sit down to draw the attention of those who were not present for the debate on that earlier amendment to two important points made respectively by the noble and learned Lords, Lord Judge and Lord Mackay. My noble and learned friend Lord Judge, as I understood him, ventured the view that the new EU regulations of concern under Amendment 84 could be added to Clause 7(7). That seems to give support to this amendment. If we went down that route, we would be doing exactly the same for data protection issues as for clinical trials. That suggests that there is scope in the Bill for specific EU regulations to be given particular protection where it is considered of such importance to the rights and safeguards of citizens.

Similarly, on the same amendment—I would need to read Hansard to check that I understood it correctly—the noble and learned Lord, Lord Mackay of Clashfern, made a contribution that was extremely helpful to the Minister, who, if I may put it delicately, was in a little trouble over that amendment. He suggested that, where there were new provisions and some ambiguity about whether the full protections would be safeguarded, it would be open to this House and the Government to consider putting a list of regulations requiring special protection in some form in this Bill.

If that course of action commended itself to the Government before Report, I would respectfully suggest that data protection should be on that list as something that will be given particular protection. I think there is a very strong case, as the noble Lord, Lord Stevenson, has argued very convincingly, to give some special protections in the Bill to data protection. Regardless of whether this amendment is precisely the right wording, or whether there is another way of doing it, I think that the noble Lord has made the case, just as I think that we made the case earlier this afternoon on clinical trials regulations. I think the Government need to think, in the way that the noble and learned Lord, Lord Mackay of Clashfern, was saying, about the kinds of issues that merit that kind of protection if we are to safeguard well-earned citizens’ rights and protections that have built up over time.

[Lord Clement-Jones (LD)]

My Lords, it is a pleasure to follow the noble Lord, Lord Warner, and speak to Amendment 88 and the other amendments in this group. I very much support the words and the very comprehensive introduction that was given by the noble Lord, Lord Stevenson. It is vital to many key sectors—manufacturing, retail, health, information technology and financial services in particular—that the free flow of data between ourselves and the EU continues post Brexit with minimum disruption. With an increasingly digital economy, this is critical for international trade. TechUK, TheCityUK, the ABI, our own European Affairs Sub-Committee and the UK Information Commissioner herself have all persuasively argued that we need to ensure that our data protection legislation is treated as adequate for the purpose of permitting cross-border data flow into and out of the EU, post Brexit.

Fears were expressed in Committee and eventually the Data Protection Bill was amended on Report and at Third Reading to show that some principles, at least, were incorporated in the Bill, despite the fact that the European Charter of Fundamental Rights will not become part of UK law as part of the replication process in this Bill. The noble Lord, Lord Stevenson, quoted the Prime Minister’s recent Mansion House speech, a speech that I am sure will be quoted many times, when she said that,

“we will need an arrangement for data protection. I made this point in Munich in relation to our security relationship. But the free flow of data is also critical for both sides in any modern trading relationship too. The UK has exceptionally high standards of data protection. And we want to secure an agreement with the EU that provides the stability and confidence for EU and UK business and individuals to achieve our aims in maintaining and developing the UK’s strong trading and economic links with the EU. That is why”—

this is exactly what the noble Lord, Lord Stevenson, said—

“we will be seeking more than just an adequacy arrangement and want to see an appropriate ongoing role for the UK’s Information Commissioner’s Office”.

Whether or not something more than adequacy will be available—the noble Lord, Lord Stevenson, also dealt with this—depends on the EU, which states quite clearly, in paragraph 11 of its recent draft negotiating guidelines:

“In the light of the importance of data flows in several components of the future relationships, personal data protection should be governed by Union rules on adequacy with a view to ensuring a level of protection essentially equivalent to that of the Union”.


I have slightly more extensively quoted paragraph 11 of the recent guidelines, but the difference between those two statements is notable. Both the statements recognise the fact, as many of us emphasised in this House during the passage of the Data Protection Bill, that the alignment of our data protection with the EU is an intensely important issue. There will be a spotlight on the question of whether we meet an adequacy assessment by the European Commission, which I think we all agree is necessary and essential.

As I said on Report and at Third Reading of the Data Protection Bill, the Government added a new clause designed to meet the adequacy test in future, yet this Bill also gives Ministers power to make secondary legislation to amend any retained EU law, which would include laws governing data protection rights. So the Government could give with one hand and take away with the other. This amendment, as the noble Lord, Lord Stevenson, emphasised, is exactly designed to avoid a situation where our data protection law does not meet the adequacy test, to the great disadvantage of our digital economy and other sectors. Set against this danger, it cannot be necessary or desirable to exercise any of the powers in Clauses 7, 8 and 9 to repeal any part of our data protection legislation, which we have so carefully crafted and adopted. These are probing amendments but I certainly hope the Minister can give us the necessary assurance to make sure that such amendments do not reappear on Report.

Health and Social Care Bill

Debate between Lord Warner and Lord Clement-Jones

Tuesday 13th December 2011 Lords Chamber

[Lord Clement-Jones]

I am grateful to the noble Baroness.

[Lord Warner]

Is the Committee happy for me to continue? I consider that research evidence as is available, such as that carried out by Dr Zack Cooper at the LSE, shows the benefits of competition and supports the view that competition, when used sensibly, improves services for patients and can indeed save lives. It is perfectly possible to support both competition and integration; they are not mutually incompatible. I shall not pursue the evidence base for my views today. However, I should like to clarify briefly the circumstances in which we should be supporting the use of competition in the NHS in the best interests of patients and why it is important to tackle barriers to entry to the NHS market. It is important to recognise that we already have an NHS market in which many NHS providers do indeed compete for patients against other NHS providers. The Bill does not suddenly inject competition into the NHS but merely tries to impose some better rules and a system for regulating that competition.

There are basically three sets of circumstances in which competition could—not should—be used. The first is that, as a matter of principle, all NHS providers should be subject to market testing periodically. The second is when there is clear provider failure and it seems sensible to test the market to establish the best set of arrangements for replacing the failed incumbent. The third is where there is a set of circumstances when the NHS itself—the commissioners in practice—wish to change significantly the way in which services are provided and it is not apparent that the current incumbents can adjust quickly to the patient’s needs. The first set of circumstances has often caused a great deal of angst in the discussion of competition. I certainly do not start from that position. I believe that it is the second and third areas that I have described where we need to examine whether there are real barriers to entry by new providers, irrespective of whether those providers come from elsewhere in the NHS—from the private sector, social enterprise or the voluntary organisations.

Amendment 266 is concerned to establish much more clearly than now what the barriers to NHS market entry are. We know from the work of the collaboration and competition panel that primary care trusts have behaved in anti-competitive ways and have frustrated the best interests of patients. We know from the experience of the East Surrey nurses when they tried to set up a social enterprise how frustrated they were at changing themselves from NHS employees into a social enterprise so that they could compete for NHS business. We know that across the voluntary sector, voluntary organisations have been frustrated over their attempts to compete for NHS services over a long period of time. We also know that many private providers of services find the tendering processes for providing NHS services prolonged and excessively expensive and that they are too often frustrated by shifting political opinions about the desirability of competition.

I could go on with examples of the way in which the NHS has effectively shut the door to new entrants. Some of the most recent examples are the ways in which many primary care trusts divested themselves of their provider services without any proper system of market testing when it was clear that many of those services were extremely inefficient. We need to take the NHS out of its comfort zone in a future where it faces a huge set of demographic and financial challenges. Keeping it in the NHS family is no longer acceptable or in the public interest. We need an independent, authoritative and robust analysis of the barriers to entry to the NHS market so that we can consider what action should be taken to remove those barriers. Amendment 266 proposes that Monitor does this within a year of Royal Assent. I believe that Monitor would welcome being given this assignment but I would be more than willing to consider alternatives if the Government thought, for example, that the Office of Fair Trading was a more appropriate organisation to do the job. It is important that we get this job done as speedily as possible. I also support Amendments 278 and 287 to which the noble Lord, Lord Patel, will be speaking and to which I have added my name.

Health and Social Care Bill

Debate between Lord Warner and Lord Clement-Jones

Monday 28th November 2011 Lords Chamber

[Lord Warner]

My Lords, I rise to speak in support of Amendments 124, 125, 126 and 196, which are in my name in this group. These amendments are on slightly different aspects of patient involvement and patient choice in new Sections 13H and 13I in Clause 20.

Amendment 124 adds words to the duty under new Section 13H to promote the involvement of each patient. Nothing seems more likely to promote that involvement than ensuring that patients have easy access to their own medical records and, even better, hold their own medical records. The amendment puts those matters in the Bill as part of the duty of promoting patient involvement in decisions about their treatment and care. If patients are to be involved in decision-making, it is important that they can be confident about the information about them that is being held by clinicians and used by those clinicians in making decisions about them. We have moved a long way from a position in which doctors could say, “Trust me, I’m a doctor”. That is not to say that patients do not place a lot of trust in doctors, but the more examples of systems failure that patients hear about, the more I suspect they will want to be sure about what the system has on record about them. This is particularly true when we are dealing with end-of-life issues. Some of us are very keen to ensure that doctors and nurses observe our advance decisions in living wills that are placed in medical records rather than just make decisions on our behalf.

Amendment 125 literally follows on from Amendment 124 and reflects a number of conversations that several of us have had with National Voices, which speaks on behalf of many charities, especially those representing people with long-term conditions. National Voices, with assistance from the Health Foundation, has drawn on a lot of work to distil what it believes service-users expect from those commissioning care. The noble Baroness, Lady Finlay, referred to the work being done by the Health Foundation. This work with National Voices was born from the huge frustration of patients, service-users and carers about the way that they are often treated by those providing services. National Voices has also set out the results of this work in an excellent document called Principles of Integrated Care. Many Members of this Committee may well have a copy of it. If the Minister has not seen it, I commend it to him. I am certain that it has been sent to Sir David Nicholson. Around 50 chief executives or chairs of voluntary organisations involved with National Voices signed a letter to him, commending this piece of work.

Amendment 125 tries to ensure that there is a clear obligation on clinical commissioning groups to pay heed to patients’ and service-users’ voices in their commissioning of services and that the board issues guidance in this area to clinical commissioning groups. I hope that today the Minister will at least take away this amendment, discuss it in detail with National Voices and those of us who are involved in this area, and agree a version that can be included in the Bill and with which everyone is content. Of course, if he wishes to say “Snap!” to these words, we will be delighted. I emphasise that Amendment 125 does not come from the fertile minds of people in this Committee. It comes from the experience and views of many thousands of people with long-term conditions whose representatives have discussed and researched this very thoroughly within the ambit of the Health Foundation and National Voices.

Amendment 126 is on a different topic altogether. It tries to sharpen the duty of patient choice in new Section 13I in Clause 20, which in my view is pitifully vague. When they are exercising choice, people need to know what the speed of access to diagnosis and treatment is; where the location options and alternative providers of service are; and some information on the different levels of performance by those providers. Choice cannot be exercised in a vacuum. If people are to exercise meaningful choice, they need information that they can draw on to make their decisions about what is best for them. They should not simply be guided to local incumbents, which is too often the case in the system as it works now. Very often, those local incumbents may not be the best option for the patient seeking services for their particular condition at a particular time in their life.

I speak with some confidence on this, having spent two years as a Health Minister trying to advance the cause of patient choice. I have had a fair exposure to clinical views about patients not wanting it and just wanting a good local hospital. I have seen at close quarters commissioners in excessively close relationships with local providers. I have heard the voices of patients frustrated at being denied the information they need to exercise choice. I have experienced, at first hand, consultants declining to place their consultation slots on the Choose and Book system. I know that we need much more than the vague wording of new Section 131 in Clause 20 of the Bill. I hope that the Minister, who I know to be a strong advocate of patient choice, will throw away his brief and say yes, we do need more specific wording of the kind in Amendment 126.

I hope the Minister will do likewise in respect of Amendment 196, which applies the same increased precision to the duty as to patient choice and places it on clinical commissioning groups as well as the board. I will not go over the arguments again, as they are exactly the same as those I have deployed on Amendment 126. It is even more important to disturb the cosiness of provider incumbency when we come to clinical commissioning groups. I have added a little piquancy to the clinical commissioning groups amendment by a specific reference to end-of-life care, where we badly need more options for people to choose from if their preferences are to be delivered.

I have spoken for too long already, but I also wish to add my support to the amendments in the name of the noble Lord, Lord Patel, to which I have added my name.

[Lord Clement-Jones]

My Lords, I shall speak to Amendments 127B and 197B. As they relate to pharmacy, I declare an interest as the chairman of the Council of the School of Pharmacy, University of London. The intention of these amendments is to ensure that all relevant healthcare providers, including community pharmacists, are consulted when the NHS Commissioning Board and commissioning groups are discharging their functions and developing their business and communications plans. The essence of these amendments is to retain the long-standing arrangement whereby, under the 2006 Act, commissioning bodies have to consult widely and in good time with all relevant stakeholders, including local service providers or their representatives.

Under the current system, primary care trusts are required to consult widely in relation to their commissioning duties. There is concern in the pharmacy profession that the current provisions under Clause 20, new Section 13J, for the board, and Clause 23, new Section 14V, for clinical commissioning groups, to obtain appropriate advice are too vague. It is important that consultation with all local healthcare providers should be done via local representative bodies as well as directly with providers. Clinical commissioning groups should consult pharmacy professionals when making decisions in relation to the commissioning of relevant services in order that the professional skills, knowledge and expertise of pharmacists are used in planning, commissioning, delivering and evaluating NHS services. They should also demonstrate arrangements systematically to seek the views of all appropriate local clinical groups throughout the commissioning process, in general and for particular services. This would include ensuring that all local representative committees are fully engaged in the commissioning process and signed up to the outcomes agreed.

As part of their local leadership role, clinical commissioning groups also need open and transparent processes for reconciling different professional perspectives and contingency arrangements for seeking the agreement of non-GP professional groups in the case of urgent service change. These processes should be clearly set out as part of the CCG’s governance procedures for commissioning decision-making. The above will be of particular importance in the immediate term, given the influx of new commissioners into the market, to ensure commissioners commission services effectively. Without relevant healthcare providers being consulted, the different contributions that such providers, including pharmacy, can make to local healthcare could be lost.

If used effectively, pharmacy has the potential to deliver a great deal more both to patients and commissioners. For example, it is estimated that some 57 million GP consultations each year involve minor ailments which could be dealt with at a pharmacy. If these patients could be moved to a pharmacy, more than £812 million could be saved annually, and GP capacity could be freed up to deal with more complex cases.

In summary, it is critical that there is a duty on commissioning groups, when developing their commissioning plans, to consult primary care providers such as pharmacists as there is a danger under the proposed legislation that some groups may not do so, leading to ineffective commissioning of services. At the Royal Pharmaceutical Society Conference in September, the Minister said that pharmacists are pivotal to every aspect of the Government’s plans to modernise the NHS. I find those words very encouraging and hope that he can give further encouragement in the course of this debate.