Authors

Dr. Stefanie Greifeneder

Partner

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Sarah Aschenbrenner

Associate

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Authors

Dr. Stefanie Greifeneder

Partner

Read More

Sarah Aschenbrenner

Associate

Read More

6 June 2024

Femtech article series| June 2024 – 3 of 6 Insights

Gender Data Gap and Femtech: A Legal Perspective

  • Briefing

Medical advancements over recent decades have significantly improved the diagnosis and treatment of many diseases, yet a significant imbalance remains: the neglect of specific health data pertaining to women in research.

This phenomenon, known as the Gender Data Gap, significantly hampers the effectiveness and safety of medical treatment for women. In parallel, the Femtech industry is emerging, which utilises innovative technologies to specifically address and enhance the health needs of women.

 

The Gender Data Gap in Medical Research

Historically, the male body has been regarded as the norm in medical science. This practice has resulted in the majority of medical knowledge being derived from studies involving male subjects. This bias has far-reaching consequences for women’s healthcare, including inappropriate medication dosages for the female metabolism and delayed or incorrect diagnoses of gender-specific conditions such as heart diseases or strokes.

In the USA, this issue was addressed by the enactment of the NIH Revitalization Act in 1993, which explicitly requires the inclusion of women in clinical trials funded by the National Institutes of Health. This law stipulates that women and minorities must be adequately represented in all clinical research projects, where "adequate" means that the study participants reflect the population relevant to the specific disease.

 

Current Situation in Europe

National legal regulations and EU law have long demanded that in Germany and Europe, drugs should only be approved if there is sufficient evidence from clinical trials for both men and women.

In the EU, awareness of the need for gender-equitable research has been strengthened, particularly through Regulation (EU) No. 536/2014 on clinical trials of medicinal products for human use. This regulation demands in Annex I Section D that the application dossier must include a justification for the gender and age distribution of the trial participants, and if a gender or age group is excluded or underrepresented in the clinical trials, an explanation of the reasons for this and a justification of the exclusion criteria. Preamble 14 of the regulation also emphasizes that the participants in a clinical trial should be representative of the population groups, including gender and age groups, that are likely to use the investigated drug, unless the trial plan contains a justified alternative arrangement. These regulations are flanked by the recommendations of ethics committees, which conduct an ethical review of every clinical study in Germany and observe special guidelines for gender equity.

The Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI) are also working at the national level to comprehensively consider gender-specific differences in the research, development, approval, and monitoring of new drugs and therapies. Their goal is to close the Gender Data Gap in the field of drug therapy, particularly with regard to women.

Pharmacoepidemiological and pharmacovigilance studies, as well as the evaluation of safety signals, expand knowledge about gender-specific differences in side effects and raise awareness of potential differences between female and male patients. This is crucial to improving drug safety. BfArM and PEI focus their research on current and relevant topics concerning both drug approval and the optimisation of drug safety. The research groups for pharmacogenomics and individualised pharmacotherapy, as well as pharmacoepidemiology at BfArM, make a significant contribution to the study of gender-specific differences in the pharmacological effects and side effects of drugs. The insights gained enable the development of modern, personalised treatment approaches and enhance the safety of new drugs for all patients.

The existing draft for the new Medical Research Act aims to strengthen existing regulations and ensure comprehensive consideration of all diversities right from the ethics vote for clinical studies. According to § 41c of the draft, a specialised ethics committee for special procedures will be established, ensuring that both female and male members and deputy members are equally represented. This committee consists of members with interdisciplinary expertise, including lawyers, ethics experts, statisticians, doctors with experience in clinical medicine, specialists in clinical pharmacology or pharmacology and toxicology, and laypersons. These measures are intended to more strongly integrate and promote the diversity perspective in medical research from the outset.

Despite these legislative advances, the actual implementation in practice remains a challenge. Many studies show that women, particularly in the early phases of medical research, are still underrepresented. Continuous monitoring by regulatory authorities and the adjustment of legal requirements are therefore crucial to achieving genuine equality in medical research and improving the quality of healthcare for women.

 

Future Developments and the Path Forward

Closing the Gender Data Gap in medical research requires ongoing financial and institutional support for studies that deal with gender-specific differences. Another obstacle is the cultural and institutional insistence on outdated medical models that set the male body as the standard. Strategies to overcome these challenges include promoting gender equity in research funding institutions and increasing the involvement of women in research development at all levels. Moreover, trends are emerging that indicate stronger regulation and support for Femtech, such as new legislative initiatives prescribing a more even gender distribution in clinical studies.

The need to close the Gender Data Gap in medical research is underscored by various legal and political initiatives. While there is no specific "Law on the Promotion of Gender-Equitable Research" in Germany, there are funding programs and guidelines aimed at improving gender equity in research. These initiatives require that all medical research projects receiving federal funding must ensure that women and men are equally represented in the studies. For example, guidelines recommend that the participation rate of women in clinical studies should be as high as possible unless there is a valid scientific reason for deviation.

The development and implementation of these guidelines and funding programs have been significantly advanced by the inter-ministerial working group on Gender Equity in Science, supported by leading female scientists and feminist organisations. These groups emphasise how gender-neutral research approaches can lead to medications and treatments that are suboptimal or even harmful to women.

An example of such a funding program is the "Gendered Innovations" project of the European Commission, which aims to promote the integration of the gender dimension in research and innovation. This project provides concrete methods and case studies to help scientists consider gender-specific differences in their research projects.

In addition to national initiatives, efforts at the European level are underway to promote gender equity in research. The European Union has laid down guidelines that prescribe that all EU-funded health research projects must integrate a gender perspective to ensure equal participation and treatment in clinical studies. Another example is the "Horizon Europe" framework programme, which has embedded gender equity as a cross-cutting theme, ensuring that all research and innovation projects must consider the gender dimension.

These legal and political frameworks are crucial for improving medical research outcomes by ensuring that the different biological and gender-specific responses of both genders are adequately investigated. The enforcement of these guidelines and programs requires continuous monitoring and adjustment of research practices to maintain the integrity of medical science and optimise healthcare for all genders.

Another example is the German Research Foundation (DFG), which also demands the consideration of gender aspects in its funding programs. Projects that consider gender aspects can thus receive additional funding opportunities. This is intended to systematically consider gender-specific differences in research and reduce the Gender Data Gap.

In summary, these measures and initiatives show that promoting gender-equitable research is a significant concern both at the national and European levels. Continuous adjustment and monitoring of these measures are necessary to ensure fair and balanced healthcare for all genders.

 

Conclusion

The Gender Data Gap in medical research has profound implications for women's health. The rise of Femtech and the increased consideration of gender-specific differences in research mark the beginning of a more comprehensive and just medical practice. This development underscores the need for continued efforts, legal oversight, and constant innovation of technologies tailored to the specific needs of women. The ultimate goal is to ensure healthcare that treats all people fairly and effectively, regardless of their gender.

Addressing the Gender Data Gap and promoting the Femtech industry are essential to improving the quality of medical research and healthcare for women globally. By breaking down barriers and supporting innovative solutions, a more comprehensive and equitable healthcare provision can be achieved. However, why are the legal perspective and the promotion of Femtech so crucial? Legal frameworks secure compliance with data protection and ethical standards, while Femtech specifically addresses the long-neglected health needs of women. Only through these coordinated efforts can global health disparities faced by women be reduced and ultimately eliminated.

Expanding and enforcing laws and regulations that promote gender-equitable research are essential. They ensure that the differences in the biological and gender-specific responses of both genders are adequately considered. Continuous monitoring and adjustment of research practices are necessary to maintain the integrity of medical science and ensure optimal healthcare for all genders. Concurrently, the focus must continue on the development and implementation of universal data protection standards to strengthen trust in Femtech applications and promote their acceptance and effectiveness in clinical practice.

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