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Community activist Emma Friedmann explains the caution needed regarding pharma, Brexit and regulation

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EMMA FRIEDMANN: Hi, my name’s Emma Freidman, and I campaigned for better pharmaceutical regulation. The law here in the UK does not protect victims of pharmaceutical harm. Now maybe this is something that’s going to come out when we officially leave the EU, that we again would have the choice between sticking at our laws, our British laws as they are, which are regarding consumer protection. They are inadequate. Our access to justice is inadequate because of the reforms to legal aid and because of the way that the legal aid agency will assess the probability of success for a case. My experience with the conservatives is that they are not interested in making changes to the law, and they are not interested in making sure that victims of pharmaceutical or medical device harm get access to justice or get some kind of recompense. That is falling on our NHS, on our local authorities, and on our welfare state. Leaving the European Medicine Agency, if we’ve got tight regulation, we’re going to have safer products. If we’ve got loose regulation, we’re not going to be able to guarantee the safety of those products, and we have no way of seeking recompense from the companies, and it will be the state who are paying for the NHS services, the social services, the welfare, the housing. Whatever comes with disability, it will be the UK state that pays for that rather than the pharmaceutical companies making a contribution. That happens at the moment. It’s happened for my son. He’s been harmed by a drug I took while pregnant. I took a medication during pregnancy that has harmed my child. The medication I took was sodium valproate, Epilim. I took this medicine because I was told that there was minimal risk that something would happen to my child. I then later found out that my son’s disabilities were caused by this drug, so we pursued a legal action with 160 other families. The legal aid was withdrawn, and so my child has not been able to access justice. I then set out on a journey to learn a bit more about medicine regulation and how we actually make people aware that this particular drug during pregnancy is not safe. We have managed to get a referral from the MHRA to the European Medicine Agency to issue warnings. Within the European Medicine Agency, they now say, “Sodium valproate is not to be prescribed to a female of childbearing potential unless everything else is ineffective or not tolerated.” We have got labels on the outside of the boxes. We have got updates in the patient information leaflet. We have all of the websites updated. We have been working with NHS Improvement and NHS Digital to ensure that all of the GP computer systems now have a popup whenever a GP wants to prescribe this drug. We very much feel as if we have achieved the success. Outside of the EU, we need to have this conversation about how are we actually going to do this kind of thing. Regulation currently is dealt with in member states, and then there’s European bodies. In the UK regarding pharmaceutical regulation, we have the MHRA, the Medicines and Healthcare Products Regulatory Agency. They deal with things in the UK, but they answer to the European Medicine Agency. Brexit will affect regulation because our regulators answer to European regulators. Within the pharmaceutical industry, there is the MHRA, the Medicines and Healthcare Regulatory Agency, here in the UK, and they answer to the European Medicine Agency. Now, the European Medicine Agency is currently based in London. They use a lot of resources. Lots of our scientists, our regulators work within the European Medicine Agency as well. We will need to set up our own regulator that has the teeth the European Medicine Agency has. If regulation is less strict here in the UK, then businesses would be able to benefit by bringing their product here to the UK and in effect trialing it on UK citizens, taking that data so that when they approach the European Medicine Agency or American agency or elsewhere, they have this bumph of information that they can say, “Okay, we’ve trialed this on 10,000 UK citizens. That is part of our evidence to show the effectiveness of the product.” One thing that we have to ask ourselves as citizens when we think about voting is do we want to be trialed on? Do we want to take part in clinical trials ourself with no choice? Are we prepared to accept a product that might be substandard? It might be new and innovative, and there might be positive things happening under a microscope, but do we want that for our children? Businesses find regulation a bit of a barrier in a negative way because they want to sell something on the cheap. They want to put a minimal amount of cost into the production of it. If we have a very, very poor regulatory system where everything is done to benefit business profit, then businesses will also benefit because they will not have to put the millions into the research and the proving that the drug is safe. Regulation could be improved by Brexit because the European Medicine Agency is definitely not a perfect organization. There are loads of people who have a lot of criticism about the way the European Medicine Agency runs, about the revolving door from the pharmaceutical industry to the regulator and vice versa, the fact that some of their reviews don’t appear to have been as thorough as they should have been, the fact that information has been excluded from reviews. We have an opportunity with Brexit in many areas of regulation, but within the pharmaceutical industry, we could invest in the MHRA. We could invest in the Yellow Card, which is the UK system for reporting adverse drug reactions. We could invest in the Clinical Practice Research Datalink, which is data that is collected from over 480 GP surgeries across the UK that have patients that are representative of the UK population in all socioeconomic, race, culture group. If they license a product here in the UK and we are the best regulatory agency in the world, then their product can be sold globally. As it is at the moment, a product may get licensed in the States, then it will get a license in the EU, then it will get a license elsewhere. If these pharma companies just come here, they design their product, they license it here in the UK, and we are seen as the best in the world, then pharma will just come and license their products here, and then they’ve got a cleans swig. The rest of the world will take the product on. But we have to reach that particular standard. Regulation is important because it sets a standard that the product will always have to meet, or the service, so that the consumer knows that every time they use that product, it will be of a certain standard. It will taste the same, smell the same, feel the same, do the same to your body. It also looks after our safety, patient safety or citizen safety.

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