Medicines and Medical Devices Bill

Lord Crisp Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

Many of us complain about the hardships resulting from the lockdowns associated with Covid. The African Union’s Dr Ngozi Okonjo-Iweala told our Select Committee that fears across developing nations were not about lockdowns, but about being locked out—locked out because of monopolies, vested interests and self-interest. Compared with countries that have been capitalising and profiteering on the back of Covid-19, the United Kingdom has values and a reputation of which we are justifiably proud. The amendment in the name of the noble Baroness, Lady Sheehan, gives us an opportunity to demonstrate that that reputation is well deserved.

[Lord Crisp (CB) [V]]

My Lords, I support Amendment 19, which would have been important at any time, but is, of course, as we have already heard, particularly important at the moment. I will speak briefly, and I can do so thanks to the eloquent contributions by the noble Baroness, Lady Sheehan, in moving the amendment and by my noble friend Lord Alton.

There are points of principle here, and practical points. I start with the points of principle. First, the UK signed up to the International Covenant on Economic, Social and Cultural Rights in 1976, which guarantees access to medicines as part of the right to the highest attainable standard of health. This should be integral to all our medicines regulation.

Secondly, as we have heard, the World Trade Organization’s TRIPS Agreement explicitly included public health standards, giving countries the right to grant compulsory licences and to determine where there is a national emergency, and the freedom to establish a regime of exhaustion of intellectual property rights—in other words, taking control of access to medicines on behalf of their populations. Both these principles are underpinned by the basic responsibility that Governments have for maintaining, protecting and improving the health of their people, but also by the wider points that my noble friend Lord Alton just talked about on our interconnectedness and responsibilities to our fellow citizens of the world, in our own self-interest as well as from other motivations.

However, as the noble Lord and the noble Baroness said, in addition to principles there are very practical issues that should guide our thinking on this. The first is that there is good precedent. The UK and other Governments have used, and/or threatened to use, these rights on several occasions over the years with good effect for the benefit of their people. They are useful and viable measures, and should be at the front of our minds at this time, because—here the point is being made again—the response to Covid is bringing with it a frankly unprecedented number of new treatments and vaccines in a relatively short period of time. It is vital that these are made available as quickly, widely and cheaply as possible, not just in the UK.

I echo the questions from the noble Baroness, Lady Sheehan. I will be interested to hear the Minister’s response about our participation as a country in the global sharing and the global effort.

It was good to hear my noble friend Lord Alton’s description of the situation in Africa and of the imperative need for us to bear that in mind in our policy-making here in the UK, while also bearing in mind the great reputation that we have had over several years for doing so. On Friday, I got in touch with the World Health Organization in Africa. Some of the figures that the person I spoke to talked about, regarding the impact of the pandemic on wider health issues, were formidable indeed. I was told that we have lost the gains of 25 years in the past 25 weeks—an extremely depressing statement.

Just as depressing, as both noble Lords mentioned, is the fact that we are already seeing signs of the way in which some pharmaceutical companies will approach this extraordinary period of new vaccines and treatments in what is happening with remdesivir, with shortages and treatment rationing here in the UK, let alone anywhere else.

This amendment is absolutely right in asserting that the UK should reaffirm its position and its rights to protect the health of its population. We should adopt it. The future will be difficult, as will the negotiations on this issue, but no one should be in any doubt about the UK’s firm position. We should support not just the UK’s position for the population of the UK directly but a global effort to deal with these important matters.

[Baroness Walmsley (LD) [V]]

My Lords, the Government take an enormous number of powers to make regulations in the Bill.

In the light of the paucity of parliamentary powers to check these, particularly prior to them coming into effect—as demonstrated by the recent Covid-19 regulations —the only way in which Parliament can influence these regulations before they are even drafted is by inserting into the Bill those things to which Ministers must have regard. That is why my noble friend Lady Sheehan seeks via Amendment 19 to insert two important elements into the Bill after the priorities of safety, availability and so-called attractiveness. I support her amendment and look forward to the Minister’s answers to her questions.

Proposed new paragraph (d) would ensure that the Government have regard to the International Covenant on Economic, Social and Cultural Rights of 1996, which the UK ratified 10 years later. This affirms a citizen’s basic human right to access medicines without discrimination, which means that they must be both affordable and available. We have committed ourselves to that.

Proposed new paragraph (e) reaffirms the international protections conferred by the WTO’s TRIPS Agreement. It recognises that these intellectual property rights protections have been misused and abused by big pharma; that resulted in the WTO’s Doha declaration of 2001, which reaffirmed public health safeguards for citizens of all nations. The details are in the amendment.

The amendment is absolutely crucial as the world awaits new tests, treatments and vaccines for Covid-19, as other noble Lords have mentioned. In particular, the pandemic demonstrates the importance of paragraph (e)(ii): the right to determine what constitutes a national emergency. The Government have used that.

However, the track record of big pharma does not bode well for equitable distribution of medicines, and this demonstrates the importance of the right to issue a Crown use licence. Drugs to treat cancers, HIV/AIDS, hepatitis C, cystic fibrosis and toxoplasmosis have all been withheld from citizens while Governments were held to ransom during negotiations with pharmaceutical companies. The NHS has had to ration necessary drugs because of price gouging. The threat of using a Crown use licence, and the actual issuing of one, has been helpful in such negotiations, and several countries have used the powers to great effect.

The issue of compensation, however, needs to be clarified. This section of the law has not been tested in court. Will the Minister commit the Government, therefore, to review Section 57A of the Patents Act to ensure that it does not block the use of the crown use licence provision? Countries such as Australia, Canada and Germany have revised their patents laws for this purpose, and other countries have taken action. Will the UK Government do the same? This power could be needed to ensure access to Covid vaccines and treatments, so time is of the essence. Will the Government act now and not just stick to business as usual?

Medicines and Medical Devices Bill

Lord Crisp Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Baroness Walmsley (LD) [V]]

My Lords, I support this amendment. When we discussed this issue in Committee, I raised the matter of Section 57A of the Patents Act 1977 and the Minister pointed out that compensation needs to be awarded to a patent holder for any loss of profits as a result of the use of a Crown use licence and argued that this should be set against the potential savings that purchasing more affordable generic alternatives enabled by a Crown use licence could bring about. Tonight, I repeat that this has never been tested in court.

The noble Baroness, Lady Sheehan, and the noble Lord, Lord Alton, mentioned Orkambi. The fact is that if the Government had issued a Crown licence and Vertex had decided to take the Government to court for compensation, the Government would probably have won the case, because they had a very strong case. Any reasonable person would have concluded that three years of failed negotiations showed that Vertex could not make the case that the NHS would definitely have bought the product from them had a Crown use licence not been issued. Had they taken the thing to court, the Government would probably have won the case, and the fact that they did not means that they really missed an opportunity to set a useful new precedent by fighting an interpretation that would render the entire Crown use provision next to useless.

I shall add just a few words about the Covid-19 pandemic. Many countries, such as Germany, Hungary, Canada and Australia, have made alterations to their patent laws to make issuing a compulsory licence easier, in the interests of public health. That is because, in those countries, it is accepted as a valuable tool that can help overcome pricing and manufacturing barriers to accessing crucial vaccines, medicines and diagnostics which could help save millions of lives. Will the UK Government follow this example, set a precedent, next time the opportunity presents itself, and make the necessary changes to our law to make it easier, not more complex, to use our legal right of issuing a Crown use licence to protect public health?

[Lord Crisp (CB) [V]]

My Lords, I am very pleased to add my name to the amendment in the name of the noble Baroness, Lady Sheehan. I shall be brief and limit myself to one central point, because the arguments have been put so well by noble Lords who have already spoken. At its heart, this amendment is about achieving the right balance between the public interest and private interests. In this particular context, it is clear to me that the Government should commit themselves clearly to safeguarding the public interest and to taking action on—let me stress this—those rare occasions when it will be necessary.

This is particularly vital, as other noble Lords have said today and on earlier occasions, because, sadly, there is a history of price gouging and exploitation of the public. There has also been lack of transparency and, of course, one should also note that the development of many treatments and vaccines have benefitted from public investment. I hope the Minister will be able to make the commitments that the noble Baroness, Lady Sheehan, has requested.

[Baroness Jolly (LD) [V]]

My Lords, the purpose of this amendment, tabled by my noble friend Lady Sheehan, with cross-party support, is to ensure that fair and affordable access to medicines for all must be a consideration when regulations are made with respect to human medicines. This is key for two reasons. The first is to ensure that medicines, including on the NHS, are available at a fair price. We know that the NHS buys medicines at an industrial scale and is very able to be tough in its bargaining to get a good deal for the taxpayer. The second is that the British Government used to play a pivotal role, through DfID, in helping many across the world in the eradication of polio and other life-changing or life-threatening diseases. Will the Minister outline what criteria are used now that DfID has been subsumed by FCDO?

On Covid-19, collaboration on the production of vaccines is critical. What is being done by the Government to collaborate in this life-saving mission? Time is of the essence. Can the Minister tell us where we are now and outline what support is going to those who have neither the contacts nor the money to fund these vaccinations? Our economy has taken a serious hit, but we have a moral duty to support those with no industry, and so no income. I endorse all the comments from the noble Lord, Lord Crisp, who has many years’ experience of these issues—many more than I have. I would be grateful if the Minister could answer my questions.