Women’s health is a global priority. The legacy of undervaluing women has resulted in less funding for women’s health research, and thus a data and health gap for women. This symposium explored the urgent need for safe, effective, and accessible medicines in pregnancy, equitable access to menopause care and the role of regulators.
The symposium was conceived and chaired by Dr Anna Zecharia, Director of Policy & Public Affairs at the Society and member of the EDIS development board, and Dr Sheuli Porkess, Vice-President Faculty of Pharmaceutical Medicine (FPM) and Director of Actaros Consultancy. For both the Society and FPM, women’s health is a priority area and for the Society, a key focus of our strategy. In 2020, we published our vision for inclusive pharmacology, which states that the Society puts "inclusion at the heart of pharmacology, whether in terms of the opportunity for a successful career or in benefitting from pharmacology research". We know that women are an underserved population, outlined in the Society's perspective as part of consultation for the new Women's Health Strategy for England, and have explored this and other issues through our Unmet Health Needs blog series.
The first speaker was Dr Allyah Abbas-Hanif, a GP and Honorary Senior Lecturer at Imperial College London, who spoke about where we are with medicines development in pregnancy. She highlighted the policy commission report Healthy Mum, Healthy Baby, Healthy Future and its recommendations which emphasise the importance of the health of the mother throughout pregnancy because it can impact generational health.
Dr Abbas-Hanif argued we need to improve how we run clinical trials, especially regarding the complexity of pregnancy. However, there has been a significant call to action with recent reports and reviews about this underserved population and there are also several important workshops about regulation taking place. These include plans to develop a new International Council for Harmonisation (ICH) efficacy guideline on the ‘Inclusion of pregnancy and breastfeeding individuals in clinical trials’ and the potential for obstetric (or maternity) investigation plans. Dr Abbas-Hanif ended on the crucial point that advocacy, investment and policy are essential to enhance public understanding.
When asked about the next steps for the commission, Dr Abbas-Hanif called for the formation of a key steering group to continue progressing this vital ongoing work.
The next speaker was Dr Louise Newson, a GP, founder director of Newson Health, and member of the government’s newly formed menopause taskforce, who spoke about equitable access to menopause care. She started by presenting a patient’s perspective of going through the menopause, their menopausal treatment and the GP consultations that eventually led to a diagnosis of the menopause and appropriate treatment, noting the difficult journey for the patient to receive appropriate diagnosis and treatment. This experience illustrates the problems many menopausal women are going through and highlights the need for integrated care.
Dr Newson stressed the point that menopause affects all women, it leads to low oestradiol and testosterone levels and the scale of the problem is significant; by 2030 47m women will reach the menopause every year, 44% who received treatment had to wait a year or more and 13% had to wait more than five years. She outlined the risks to health with menopause, including osteoarthritis and cardiovascular disease.
When asked about her priorities and whether more research needed to be done, Dr Newson said they are doing a lot of work on social deprivation and inequality and access, as having a joined-up approach is key. She also highlighted the impact of polypharmacy on medicines – a key area for the Society – and the benefits of HRT.
The final speaker was Dr Sarah Mee, medical lead for safety and vaccines, MHRA, who spoke about the regulatory system in this area. She outlined the current gaps in drug development, and noted the changing healthcare needs across the life cycle. She noted that there are many conditions that women should not be expected to go through as ‘part of being a woman’, such as gynaecological conditions, and that women should have conversations with their doctors about these. In our Society submission to the Women’s Health Strategy inquiry, we argued the strategy should include the principle that research, healthcare and the workplace have a responsibility to adapt for women – not the other way around.
It was also highlighted how the MHRA is committed to reducing bias in development of new medical products, Dr Mee said there are ongoing consultations that the MHRA is involved in with the aim of reducing biases, for example. the paucity of clinical trials involving pregnant women during COVID-19.
Closing with a panel discussion, the core focus was about the extent to which women’s health is a women’s issue in terms of what we prioritise as a society and how. Regarding the role of education, Dr Newson said she thinks all healthcare professionals should know about the menopause, its impact on women’s health and issues around treatment delays. The Newson Health education program is popular and shows people want to learn, but it has been difficult to access the right information. Dr Abbas-Hanif argued that education could be more creative and up-to-date, and Dr Mee said the source of the educational content is particularly challenging for women, especially where to get it and to keep it updated. BPS Assessment are working in this area alongside MHRA in terms of prescribing guidance during pregnancy and also menopause.
The panel were then asked what FPM and the Society could do more of in this space. For Dr Mee, bridging the clinical-regulatory divide will be key. Dr Newson argued that it is about allowing every woman to have the option of having their hormones back, and in her blog post for the Society, argues that “all women deserve the time and the opportunity to sit down and discuss their symptoms, treatment options, medical history and personal preferences with a healthcare professional”. Dr Abbas-Hanif argued for advocacy for all the issues that had been discussed, and better communication.
Audience questions included the difficulty of recruitment in clinical trials, funding for research, and the importance of case-by-case assessment for HRT treatment. Whilst there has undoubtedly been progress in this area, there is still much to be done. A joined-up approach will be crucial, and the Society and FPM are exploring this as a collaborative piece of work.
You can watch a recording of the symposium below:
Further reading:
For further information about our work in this area, please get in touch with our policy team: policy@bps.ac.uk
Comments
If you are a British Pharmacological Society member, please
sign in to post comments.