Medicines and Medical Devices Bill

Lord Brennan Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Lord Brennan (Non-Afl)]

My Lords, this Bill, the scope of your Lordships’ debate and the report from the noble Baroness, Lady Cumberlege, emphasise the importance of government supervision of the supply, distribution and safety of medicines and medical devices.

The noble Baroness’s report is entitled a “Safety Review”. In the Commons debates, the junior Minister for the Government, Jo Churchill, described patient safety as paramount. The conduct of the affected families, described in the report, is exemplary: the way they try to cope with their suffering; their attempts to change things, to be listened to and to make reasoned submissions; and they deserve the assistance of this House and the Government.

The report refers to three conditions arising from two drug-related circumstances and one involving a medical device. The report identifies six other separate conditions that have not been investigated. History reveals to us thalidomide, the haemophiliacs given infected plasma that caused them to have AIDS, CJD or mad-cow disease, and one or two more. There has been over a dozen major, medical events affecting the safety of our people over two generations. This is a problem that is always to be dealt with—preferably before the problem happens.

The noble Baroness’s report therefore recommends that the Government should act. First, it should create a redress agency. Doctors and staff are taught “First, do no harm”. The necessary consequence of that is, if harm is done then there should be a remedy for it. That can best be done through a no-fault fairly based redress agency, which does not take away social care, special educational provision or additional provision but gives help in addition. Some of these children will never be able to manage their own affairs.

Who should pay for it? It should include manufacturers of drugs and medical devices. The industry’s capitalised market value in this country is several hundred billion pounds. The French company Sanofi, which makes sodium valproate, have a capitalised value of over €100 billion. Such companies can afford to contribute to the downside that comes from their place in the market.

Secondly, a patient safety commissioner should be created. Legislation has three principal tests: purpose, structure and effectiveness. Let us not become hypnotised by structure. What is the purpose? How can we make it effective and safe? Those questions guide us to the structure. He or she could co-operate with the MHRA and any other relevant authorities.

Lastly, as to what is to be done, the Government should set up a task force now that is government-based, with independents involved, to find out how, at what time, in what manner and at what cost this report’s recommendations can be implemented. Let us not be told that it is too complicated. Within days of becoming Prime Minister, after years of litigation in which I was involved on behalf of the haemophiliac AIDS victims, John Major’s Government publicly accepted all the terms. I thank noble Lords for their patience.

Safety of Medicines and Medical Devices

Lord Brennan Excerpts

Thursday 28th February 2019 Lords Chamber

[Lord Brennan (Lab)]

My Lords, the topic of today’s debate is well chosen by the noble Lord, Lord O’Shaughnessy. He is to be commended on his enthusiasm, both as a Minister and as a future Back-Bencher, in raising it. I give my best wishes to the noble Lord, Lord Carrington, in anticipation of his maiden speech. I would like to mention Norman Lamb, the honourable Member in the other place, and his indefatigable leadership of the APPG on Epilepsy.

As a barrister, I have been engaged over the years in many cases involving medicines and medical products with general consequences for those who use them. I have no current professional interest in any such case. However, I am the possessor and user of a pacemaker and had a double hip replacement a few months ago, so noble Lords will forgive me if I show enthusiasm for the topic in question. Improving safety, and not accepting it as a given, is a serious topic. We have to work for it, and I want to concentrate on the problem, the scale and some solutions.

On the problem, since the 1960s, the NHS and the international scope of medicines and medical devices have led to better medical treatment, but that development has had consequences. First, a far greater variety of products is produced and marketed internationally. Secondly, there is a wider impact of adverse consequences from some of those products, causing damaging conditions, both physical and mental. Thirdly, such disabilities and illnesses have a devastating effect on the families involved. This is a problem that will not go away. The greater the expansion of medical knowledge and the more demands that are placed on health services by patients, the bigger the issue will become. At the heart of this, the problem we need to bear in mind—and this is a direct point on epidemiology and causation—is who in our society will own medical big data? Will it be the media giants, the Government or institutions, or is it a public good to be owned by everybody and administered by the full gang? This is a critical aspect of the problem.

On the scale, in introducing the review led by the noble Baroness, Lady Cumberlege, Jeremy Hunt, the then Health Secretary, spoke of the “widespread harm” within the health service that had been occasioned by medicines and medical products. That is the scale domestically. Internationally, similar systems, common suppliers and the international exchange on the marketing front have become ever the greater. The problems are physical and mental. They are not gender specific, although certain of the products mentioned are particularly applicable to mothers and children of either gender; they are not age-specific. Look at the present opioid epidemic in the United States, which could occur in other countries if proper steps are not taken.

Then there are the effects in our country. Thalidomide came to light essentially because you could see what it had caused. The haemophiliac HIV/AIDS disaster came from giving haemophiliacs, mostly children, contaminated blood with the wrong factor 8 composition, leading to them getting HIV/AIDS and often dying of it. We may have forgotten mad cow disease and CJD, and the panic it produced, although the problem appeared to be small numerically.

Lastly, there is causation. How do we prove these cases? Doctors rely on academics and scientists to reassure them about use from what they observe in their own practice, but they need data. Scientists and academics must have data to show that a product is safe, so big data comes back into play. The problem is not going to go away and the scale of it is serious.

On the solution: I say yes to everything that the noble Lord, Lord O’Shaughnessy, and my noble friend Lord Hunt have said. I say yes to changes and to patient safety records, but that should be as well as—not instead of—a national, no-fault compensation fund. It is just outrageous that people who have suffered this kind of problem are driven to go to court. New Zealand and Sweden have their systems, and nobody can say that they do not work, but such a system requires interim payments, final payments and the protection of state benefits. It can be paid for by a levy—I have yet to come across a poor pharmaceutical giant that cannot afford to pay a levy, which is the same as insurance—coupled with government money and, if possible, private donations and an independent agency.

To finish quickly, causation is everything in this regard. Clear and authentic diagnostic pathways that doctors can rely on form an essential first step—the quicker you get to it, the less the problem will be. A retrospective audit process should go backwards, so that older people who develop things late are caught. We need the involvement of families and carers, some of whom are present today as observers, along with reliable management of the scheme, adequate resources, long-term financial planning, integrity and independence.

I will conclude. Because of their bravery and dignity, the people who have suffered—patients and the families who look after them, including children and older people—deserve our respect and admiration. But they demand, in justice and morality, our help through the community and society. In giving it, let us not listen to that bureaucratic homily we always get: “It takes a long time; it involves a lot of money”. On the morning of 12 December 1990, I got a phone call in my chambers. As lead counsel in a haemophiliac case, I was told that the case had been settled. I said, “What do you mean?” I was told that the Prime Minister was going to announce it in Parliament at 2 pm, which he did, and it was settled. It can be done quickly and efficiently. I thank noble Lords for their patience for my enthusiasm.