European Institute of Women’s Health

Press release:   For Immediate release

The European Institute of Women’s Health (EIWH) welcomes the European Commission’s revised pharmaceutical legislation. The EIWH promotes women’s health in policy and research, and it is of utmost importance that women’s needs are reflected in this important piece of legislation.

This revision comes at a time when policy makers and health systems are looking to future innovation to meet new health challenges. Antimicrobial resistance (AMR) is a global health threat; shortages of medicines are a growing problem; access to medicines is not equitable across the EU; and there are unmet needs for women and their families. In order to ensure timely patient access to affordable medicines, gender considerations must be embedded in these policy measures.

This new legislation must be patient centred and promote healthcare resilience. There are a number of key points in this new legislation that promote access to medicines tailored to patient’s needs. The EIWH supports the involvement of patients in product regulation as proposed in this legislation. Patients are an important conduit for expertise and a critical stakeholder for ensuring quality in medicines. The EIWH endorses the harmonisation of the reporting structure, prevention and management plan as is detailed in the legislation to mitigate the shortages of medicines.

Furthermore, the EIWH welcomes the plan to reduce the approval times for medicinal products in an effort to increase access to medicines. However, this process must not come at a risk to patient safety.

Medicines must only be approved with rigorous, comprehensive and high quality evidence and testing. The EIWH does not support the use of electronic product information as opposed to paper leaflets.

As a partner of the IDEAHL project which aims to co-create an inclusive and comprehensive EU digital health literacy strategy, it is evident that a strong digital literacy divide persists. The move to electronic leaflets will restrict access to critical health and safety information for many patients across the EU. Those with low digital literacy and areas with limited access internet access, amongst other subgroups of the population, will be the ones most affected.

Instead, the EIWH advocates for a transition period with information available both online and in paper form until a time where affected communities are adequately supported.

The EIWH recognises the difficulty in tackling the urgent problem of AMR due to the need for significant investment in research and development of novel antimicrobials coupled with the low returns promised by these products.

Nevertheless, there is concern over the use of transferrable exclusivity vouchers. We recognise that considerations have been given to aid the predictability of their use and reduce the number of vouchers in circulation, which is preferrable.

However, given the prevailing issue of affordability of many patented drugs on the market, the use of these vouchers has the potential to hinder access to medicines and exacerbate inequality.

There are two large omissions from this new legislation. Firstly, there is no mention of sex and gender in the revised document. Women are under-represented in medical research and not all clinical trial results are disaggregated by sex/gender. Due to sex and gender differences, women have a 50% higher risk of developing an adverse reaction to a drug compared to men. Provisions must be in place to ensure that there is adequate research and investment in women’s health conditions, and to include women in all parts of the research, development and regulatory process.

Secondly, the European Commission has failed to provide guidance or requirements regarding the recording and reporting of data on the use of medicines in pregnancy and breastfeeding. Most of the 5 million babies born in Europe every year have been exposed to medications during pregnancy.

Up to 98% of drugs have insufficient data

on the safety of use

in pregnancy and breastfeeding!

There is an acknowledgement that the EU pharmaceutical legislation dates back to the thalidomide tragedy, where thousands of babies were born with deformities associated with mothers taking an anti-nausea tablet for morning sickness. It is time that we move beyond excluding pregnant and lactating women from important medical safety information. Pregnant women get sick and sick women get pregnant. Pharmaceutical legislation should incorporate pregnancy pharmacovigilance data such as in the IMI CONCEPTION project.

The EIWH is a partner in this project.

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