Women's Health is developing from a long-neglected sector to a significant future market. For decades, women have been underrepresented in clinical trials and medical research. This so-called "gender data gap" has resulted in a lack of data on the effects of medicinal products, the progression of diseases and risk factors, which persists to this day. Now Women's Health and FemTech are gaining more attention from researchers, politicians, industry figures and investors. As the market grows, the legal requirements are also increasing: The regulatory framework governing everything from development of medicinal products, medical devices law, reimbursement and data protection to M&A, advertising and innovation protection is the deciding factor in whether new products and business models can be developed and marketed successfully.
Initial situation: from historic data gaps to future market
Although women make up about half the world's population, for decades this has been barely reflected in medical research and development. The female body has been systematically underrepresented in clinical trials, in medical guidelines and in product development.
Even into the 1990s, women were often systematically excluded from clinical trials. This was done partly for ostensibly protective reasons, for example out of the worry of injuring an unidentified foetus, but it was also done to simplify the design and evaluation of trials. As a result, a majority of the findings concerning the effects of medicinal products, the progression of diseases and risk factors is primarily based on male trial participants ("gender data gap"). The recommended dose for many common medications is also based on the male body.
It is clear to see now that the field is being rethought. Regulatory authorities like the EMA and the FDA now require sufficient data that include men and women with equal weight to authorise a medicinal product. Institutions, politicians and industry figures are recognising Women's Health as a distinct and economically significant sector. In particular, the market for technologies tailored to women's health (FemTech) is growing rapidly and is often the innovation-driven gateway to the Women's Health market. The willingness to invest in this sector is growing just as rapidly.
As the market grows, challenging legal and regulatory issues are also coming to the fore, which decisively affect whether new products can be marketable or eligible for reimbursement.
This article is the first in a series of articles investigating selected issues in Women's Health in more detail from a legal perspective and consequently providing a guide to the legal framework conditions.
What does Women's Health encompass?
Women's Health covers far more than just a few specific health issues. It includes different stages of life, diseases and individual needs in medical care. These follow women through every phase of their life,
ranging from reproductive health with menstrual cycles, endometriosis, contraception and fertility medicine to pregnancy, perinatal care and even to perimenopause and postmenopause. Special significance is also given to osteoporosis and lipoedema, the latter of which almost exclusively affects women and has been underestimated for a long time. Other areas for focus are cancers specific to women, such as breast, cervical, ovarian and endometrial carcinomas. There are also medicinal products and FemTech applications such as apps, wearables and diagnostic systems for managing cycles, fertility and menopause.
Women's Health: Which legal issues are important for companies?
From a legal perspective, Women's Health raises a series of specific issues that follow directly from the particular medical, regulatory and societal significance of healthcare that is tailored to women. Women's Health is also gaining relevance as an area for M&A and investment. FemTech start-ups, specialist fertility clinic chains and Women's Health divisions in large pharmaceutical corporations are receiving attention from investors and strategic buyers. Due diligence procedures in this area require understanding of the particular regulations, ongoing approval procedures and potential reimbursement risks.
In the context of medicinal products, greater consideration is being given to gender-specific trial populations, accounting for variations during a cycle in clinical trials and early assessment of the benefits of hormonal or oncological therapies. Attention is also to be paid to orphan drug designations, fast-track procedures and adaptive approval strategies for rare diseases that primarily affect women.
When products for women's health are in development, difficult regulatory questions about delineating between categories are often raised, which act as key signposts for later marketing: When does a lifestyle product become a medicinal product? When does an app meet the digital health application (DiGA) requirements?
The question of eligibility for reimbursement in women's health is also highly relevant. The debate around who should assume the costs for contraceptives, hormone replacement therapies for menopause or treatments for lipoedema shows that decisions on reimbursement are fraught not just in medical terms, but in societal and political terms too.
The options for protecting innovations in women's health also need to be considered as early as possible. Patent terms, trade mark law and protection of trade secrets are crucial factors in the success of a product, including in the area of Women's Health.
Particularly in FemTech, there are also important issues related to data protection: Cycle data, pregnancy information, genetic findings – all these fall under the category of particularly sensitive health data. FemTech providers are faced with the challenge of ensuring genuine transparency and control for users and designing international data transfers so that they comply with the law.
The law on advertising in the field of health also strictly limits messaging to consumers about prescription medicinal products, but it does allow for targeted information campaigns within some legal limits. Particularly for taboo subjects such as menopause and incontinence, the line between admissible clarification and inadmissible advertising is fluid.
Women's Health: What legal issues will receive attention in future?
Women's Health is no longer a niche issue, either in society or in law. The topics outlined here demonstrate how broad and complex the legal spectrum is that companies, investors and service providers in this field have to navigate.
In the following articles in this series, we delve into individual legal questions: First is an article on M&A aspects in Women's Health, which will be followed by one on issues related to the development of and reimbursement for medicinal products. Further articles will focus on regulatory classification of medicinal and lifestyle products. We will also take a look at apps and digital health (DiGA) applications in Women's Health and selected aspects related to data protection. Finally, the articles will address funding opportunities in Women's Health, issues under advertising law and the options for protecting innovations in women's health.
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