Medicines and Medical Devices Bill

Written Evidence Submitted by INFACT (Independent Fetal Anti-Convulsant Trust) (MMDB12)

Medicines and Medical Devices Bill 2020


INFACT SET UP IN November 2012 and registered as a charity in June 2014 running mainly from grants and donations. INFACT and its parental support group support over 1000 families affected by Valproate

Our Valproate campaign began in 2013 following a Panorama report on the drug’s issues when used in pregnancy, this was followed by a meeting with the MHRA in August that year and with the involvement of the Pharmacovigilence Risk Assessment Committee (PRAC) and the European Medicines Agency in 2014 of which INFACT had full involvement.

INFACT have had meetings with the former Minister for Life Sciences George Freeman MP and former Secretary of State for Health Jeremy Hunt MP due to our discovery of Archive documents on this matter in 2015 which led to our work with the MHRA and the setting up of the Valproate Toolkit and the Pregnancy Prevention Program. We have worked with NICE and the changes to Guidance on Valproate in pregnancy and with the General Pharmacuetical Council on the information and emphasis of that information to pharmacists.

We worked with Healthcare Professionals in the updating of the Diagnostic Criteria for Valproate presenting the outcomes to the European Reference Network in 2018, and continue to work with the World Health Organisation in the diagnosis of Fetal Valproate Spectrum Disorder and the ICD 11 coding.

Having read through the Medicines and Medical Devices Bill 2020 we have come to the following conclusions.

1. INFACT are against a rush for new medicines and the willingness to all patients to be exposed to medicines not fully tested or known to be completely safe. For example, the anti-epilepsy medication Lamotrigine can be an allergen to some, without rigorous testing this may not have been recognised early on.

2. More emphasis is required on Patient safety with in the Bill, it fails to covers what is being done to promote patient safety with medicines, better informing practice for patients, better understanding of medications for Doctors and particular specialist guidance for medications during pregnancy.

3. INFACT are against the imposing of civil sanctions on those who should and would today receive criminal prosecution. You would not avoid criminal prosecution is someone has murdered a person knowingly; with Valproate it is exactly that which has happened with Drs prescribing after being informed of the risks and being informed not to tell the patients. Allowing those harming patients knowingly to create or cause harm with a Government view to financial gain without consideration for Human Life should be avoided at all costs.

4. Prescribing rights to other Healthcare professionals should be allowed with caution. This should not interfere with the possibility of a GP appointment such as specialist prescribing would. This must not be enforced to save on GPs time. A GP has an understanding of the individual and this is of maximum importance, saving trying new medicines and patients’ anxieties.

5. INFACT agree with abolishing the exemption of allowing schools to obtain asthma inhalers to supply in an emergency for example. However, this would only work if the medication is one which is accurate for the patient, bearing in mind some allergens especially to antihistamines and anti-epilepsy medications such as Lamotrigine.

6. More emphasis on Patient Safety and safety of medicines for human consumption is required

7. There needs to be better and improved access to information for patients on their prescribed medications with a view to the Summary of Product Characteristics ( SPC) a more detailed Patient Information Leaflet On the majority of cases the PIL, especially for anti-epilepsy medications, fail to give detailed information and we find that different Pharmaceutical companies give opposing differing information.

8. There needs to be better services for Patient safety for those with Long Term Conditions. Clinical services need to be improved within the NHS with better services for required information about medication side effects.

9. Page 18 of the Bill states Pharmaceutical companies to conduct multinational clinical trials. The results of which should be made available to the public where at present they are not.

10. Pharmaceutical companies should also work in tandem with the MHRA to carry out a 5-year research into any medications new to the market, especially with Anti epilepsy medications, to conclude the safety of the drug in pregnancy, see Page 19 clause 4 (c)

June 2020

11. Page 19 states the "Rapid Introduction of new medications" as transparency is needed on clinical trials for patient safety and the understanding of the side effects and teratogenic effects.

12. It is important, due to the fact that it is unethical to use pregnant women in clinical trials, that the registry, about to be set up for Valproate and other medications, is also used to monitor and track women prescribed medications, especially Anti epilepsy drugs and anti-depressants due to their teratogenic possibilities. This way a record of all pregnancies and births will be recorded and a full and precise registry kept.


Prepared 10th June 2020