Report sets out plan to end pregnancy ‘drug drought’

Leading figures have set out a vision for improving the health of mothers and babies through the development of safe, effective, and accessible new medicines.

Launching today [Thursday 12 May 2022] in the House of Commons, the Healthy Mum, Healthy Baby, Healthy Future report has a plan of action to help make pregnancy safer for mothers and improve the chances of meeting the government’s target to halve the number of babies who die by 2025.

As the UK’s largest charity funding pregnancy research, Tommy’s was among expert organisations invited to contribute evidence to the report over the past year.

Globally, over 800 women and 12,000 newborns die every day from preventable pregnancy-related complications - that is 1 woman and 17 babies every 2 minutes.

Healthy Mum, Healthy Baby, Healthy Future makes 8 recommendations which, if introduced by government, will help develop new medicines to treat life-threatening conditions affecting mothers and their babies, and prevent needless deaths.

As well as health conditions which develop during pregnancy, pregnant women may be diagnosed with infections such as COVID-19. Many women also enter pregnancy with pre-existing conditions, such as asthma, diabetes or mental health conditions like depression.

Improving the development of effective medicines would mean healthcare professionals are better able to treat some of these conditions and potentially save mothers and babies’ lives.

Yet only 2 medicines have ever been developed specifically for pregnancy-related conditions, and not a single new medicine for some of the most serious pregnancy-specific conditions has reached women and pregnant people in decades. 

73% of drugs used in pregnancy come with no safety information relating to their use by pregnant women.

The report highlights a shocking under-investment in pregnancy and birth research and the fact that maternity data is not being used as well as it could be to support research and development.

Pregnant women must be included in clinical trials

The report recognises that that some mothers and babies are more at risk, but also that all mothers and babies have been treated unequally compared to the rest of the population. 

Ironically, attempts to protect pregnant women by excluding them from clinical trials (after the thalidomide tragedy of the late 1950s and early 1960s) may have done the opposite by denying women and babies advances in modern medicine. 

One key recommendation Tommy’s welcomes is that pregnant women should be offered the opportunity to take part in all clinical trials of medicines that could be used in pregnancy, unless there are specific safety concerns.

More key proposals for drug development

Key proposals also include strengthening the UK’s research to address gaps in our biological knowledge; better clinical trials support; and creating collaborative partnerships between government, universities and the pharmaceutical industry.

The report says that parents and families’ voices should be central in developing solutions, and that a coalition of expert charities, including Tommy’s, can help to make the case for more research into medicines.

Working together with the public, researchers and industry as well as Government, we can create a shared vision for developing and evaluating safe medicines for pregnancy.

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“Tommy’s welcomes this renewed focus on the need to consider pregnant women when developing new medicines. It’s simply unacceptable that we still lack understanding about which drugs can safely, and effectively, be used in pregnancy. Lives are put at risk and research breakthroughs and improvements in care are delayed as a result.

“It may be surprising to hear, but we know that women and pregnant people, especially those who may have experienced recurrent loss, are extremely willing to participate in drug trials and other research which could improve their own situation and help pregnant people here and across the world.” 

— Kath Abrahams, Tommy's Chief Executive

Professor Arri Coomarasamy, Director of the Tommy’s Centre for Miscarriage Research said:

“It has been unacceptable for far too long that during the development of hundreds of drugs for diseases or conditions - many of which are found in pregnant people - safety data for use in pregnancy is missing. Most recently, the exclusion of pregnant women in trials leading to the development of vaccines for COVID-19 meant a lack of information, delays in vaccination for pregnant women, and the avoidable deaths of mothers and babies.

“The UK should be a global leader in developing medicines for use in pregnancy and breastfeeding – we have the incredible research talent, infrastructure, and population to do it, but the government must now consider major public investment to ensure we can rise to the challenge.”

Professor Peter Brocklehurst from the University of Birmingham was the Policy Commission’s co-chair. He said:

“We strongly urge the scientific, clinical, industry, regulatory, governmental and public sectors to come together to address the recommendations of this Commission. The UK has the opportunity to transform maternal health across the world, improving the lives of mothers, their babies and future generations – let’s not waste it.”