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Safety of Chemicals, Medicines and Vaccines

Volume 798: debated on Tuesday 18 June 2019


Asked by

To ask Her Majesty’s Government what is their definition of “safe” in relation to chemicals, medicines and vaccines.

No effective medicine or vaccine is entirely risk free. A medicine or vaccine will get a licence only if its benefits outweigh its risk of side-effects, taking into consideration the seriousness of the medical condition being treated or vaccinated against. Chemical safety is assessed using established approaches to toxicology and risk assessment. Every substance can be toxic, depending on dose, exposure route and frequency of exposure.

My Lords, does the noble Baroness agree that these products have to have a licence because they bear risks? Would it not be better, while recognising that it is in the interests of the health of the whole community that people are vaccinated, or that they take certain drugs or use certain chemicals, to acknowledge those risks and at the same time acknowledge that some people will be damaged? It is a question of “good for all the people all the time”, or “good for some of the people some of the time”, and it is not going to cover everybody. We need to protect people who may be damaged, particularly with vaccines when parents are altruistic enough to have their children vaccinated and they then become damaged.

I agree with the noble Countess that vaccines and medicines do bear a risk. The Government acknowledge that risk, both in the way they are regulated and the clinical advice that goes with them, and in the follow-up that we do after a product is launched. I absolutely echo and recognise the concerns that she raised about the concerns of some parents and their children. We continue to take every report of a suspected side-effect extremely seriously.

My Lords, the use of the word “chemicals” seems a little curious. Is it not a fact that every Member of the Front Bench opposite is basically just a bunch of chemicals—and they may be regarded as being safe or unsafe? It seems to me that this is not a very sensible way of looking at things that are used for medicinal purposes.

I obviously cannot comment on the safety or otherwise of my colleagues on the Front Bench. We are of course “a bunch of chemicals”, as the noble Lord so elegantly put it. The serious point is that we have to find a proportionate way of regulating substances in everyday life which, when used sensibly and in line with regulation, do not present a risk to the vast majority of people.

My Lords, I am tempted to say that some of us are a less useful bunch of chemicals. Apart from that, the language you use, particularly in relation to vaccine safety, is very important. It is not true to say that vaccines cause damage; it is true to say that vaccines, on the whole, are very safe preventative medication.

That is why I am apologising to the House. Vaccines are overwhelmingly safe, but there is a tiny percentage of people who may suffer adverse effects and it is only right that we take that seriously.

My Lords, what is the system of recording adverse events related to vaccines or medicines? Given the multiplicity of databases in the NHS, how robust is that system and when was it last reviewed?

The typical system is the yellow card system, which allows us to identify safety issues with vaccines. There are limitations to it: it is widely understood that there is a degree of underreporting, and we are trying to address that through innovation—particularly through the use of apps, which will make it more accessible for us all.

My Lords, the public can be reassured that the vast majority of medicines, vaccines and medical devices are safe, yet it is a tragic fact that on occasion they cause harm—for example, in the cases we discussed in this House of sodium valproate, transvaginal mesh and others. It was for that reason that the Government set up an independent review on safety chaired by my noble friend Lady Cumberlege. I believe it is due to report by the end of the year. It had the tremendous support of our current Prime Minister. Will my noble friend give her reassurance that she will make sure that a future Prime Minister will be just as supportive of the changes it suggests?

My noble friend overestimates my powers of persuasion, but I will certainly undertake to do my best. I am grateful to him for raising the Cumberlege review, which we look forward to very much. Although the review is about specific products, it has a much wider application in its focus on identifying problems quickly, listening to patients, acting on concerns and making sure that those people get help.

My Lords, on unsafe medicines, in the event of a no-deal Brexit and without other arrangements in place the UK will not be able to participate in the shared regulatory framework within the European Medicines Agency. Can the Minister update the House on how the discussions are going to ensure close co-operation and alignment with the EMA? What preparations are being made for an entirely separate, stand-alone regulatory system for the UK if we do leave?

As the noble Baroness knows very well, our medicines are currently regulated as part of the European Medicines Agency. As many of my colleagues on the Front Bench have often said, we are aiming for an orderly and smooth withdrawal from the European Union. Noble Lords will know that it is very clear in the political declaration that we are exploring further co-operation between the EU and the UK after exit. In the event of no deal, we believe that we have put in place the processes and procedures and have the highest regulatory expertise in this area to ensure continued safety for our citizens.

My Lords, the challenge we face is that although MMR is probably the safest, most tested vaccine ever, in the light of the disgraceful linking of that vaccine with autism by Wakefield, which has been substantially discredited, in parts of this country vaccination falls below herd immunity. I am glad that the Minister apologised, because the challenge is to reassure people that the best thing they can do for their children and the community as a whole is to ensure that their children are vaccinated with MMR.

The noble Lord is quite right, and he will be aware that the department, clinicians and health professionals all around the country are working every day, if not day and night, to make that happen. There has been a slight decline in the level of uptake, but he is right to point out that in certain regions there is cause for concern, and we are absolutely focused on addressing that.