Fertility treatment opportunities in a pan-European market

 

Across the European Union (EU), more than 25 million people are affected by infertility. To place this number in context; it is equivalent to the combined populations of Denmark, Norway, Sweden, and Finland. It does not even begin to include those in gay, lesbian or alternative relationships who would like to have children of their own.

Yet it is overblown to suggest that Europe is experiencing a fertility crisis.  Partly it’s because 15 years of medical advancements have seen a vast expansion in treatment options that are widely offered across Europe. However, it is here that scientific advancement clashes with national policy decisions, as frameworks regulating fertility differ widely from country to country. This leads to significant differences in exactly who can access treatment, and the services available to them, depending on where they live.

The situation in Europe is not unique; it shares with the US the combination of declining fertility rates, changing lifestyles, evolving views on family structures and a wealthy population. However, the 508 million people living in the EU are not strictly subject to their own country’s legislative, regulatory and reimbursement frameworks.  Where these are not aligned to individual expectations, people in the EU have the freedom to look to neighbouring countries for services they cannot access in their own. This creates favourable conditions for the emergence of fertility tourism, for those who can afford it.

However, the EU fertility market remains a complex puzzle. There is a large potential market, and opportunities to consolidate in a widely fragmented system. Yet there is still a lack of certainty because public healthcare systems and social policy are still grappling with the questions that fertility solutions pose. How do different national governments’ approach to the regulation of fertility treatments modulate access to fertility solutions? How are these approaches changing? How will regulation adapt to more innovation and cross-border patient flows? Here are a few clues.

A national lottery

Public healthcare systems will always be unique; they are formed by politicians, policy-makers and public expectations of what a health system funded by the people should offer. Though there may be broad agreement about emergency services, hospitals and primary care, there can be substantial differences for anything not seen as an essential service.

This goes even further with fertility solutions, as it introduces moral and ethical argument into the equation. Require egg donation and a pre-implementation diagnosis? Well, hope you don’t live in Italy or Germany, where these services are currently illegal – even in the private system. However, in the UK, Spain and France they are perfectly fine.

Access is also dictated by the generosity of public healthcare system reimbursement, and the type of individuals who are legally entitled to access fertility services (reimbursed or not). Most European countries offer some public reimbursement for eligible individuals. Poland is a notable exception. The election of the Law and Justice Party in 2015 has seen a swing to far more socially conservative policies, and fertility reimbursement was ended in June 2016 (just two years after it was first introduced).

Looking across the five largest EU countries, a picture of overall access conditions can be created:

The UK and Spain currently offer the largest choice of services to the widest group of people. Of course, the Polish example reminds us that legislative, regulatory and reimbursement frameworks are not static. They may evolve in line with or against changing societal attitudes and as a result these access conditions can change.

The case studies illustrate the constantly changing dynamic, and highlight how legislative, regulatory and reimbursement dynamics have the potential to reshape cross-border flows, either by pushing individuals to seek services abroad or by enabling people to access treatment at home. Although France, Germany and Italy are still some distance away from the liberal frameworks in place in the UK, Spain, Belgium, Sweden and Denmark, even these countries will be unable to stand still. In the next few years, all European policy-makers and regulators will have to react to further changes in social and cultural attitudes.

Fertility preservation is likely to enter the debate. France and Germany currently only authorise egg freezing for medical reasons. But will this restriction continue to be justified in the wake of debates over gender equality, and more women looking to find the best way to balance a fulfilling career and a family life? Many of these new challenges have an ethical dimension, and some of these techniques are unlikely to be politically acceptable in more conservative European countries.

The fact that these questions remain, and that countries will find their own solution to them, suggest that the issue of cross-border patient flows will not disappear entirely.

A pan-European offer?

We know that people will travel across Europe for fertility solutions. Rather than ignore it, is it feasible to imagine a genuinely pan-European offer?

This future is highly complex. Simplification would require that regulation and reimbursement adapt on a pan-European level. The first stumbling block is that the EU has limited competencies in healthcare.  There is very little political willingness to change this and possibly even more public resistance. However, providers do not need to wait for regulatory and reimbursement frameworks to adapt to play an active role in offering services to unlock the full potential of cross-border fertility solutions.

Credible, reliable information is a major challenge for anyone looking to pay for treatment abroad. A multi-country service option could bridge this gap by providing a one-stop-shop; signposting people who cannot access treatment in their own country to services in countries where they can.

Providers should, however, expect and anticipate change. Regulatory frameworks often catch-up with reality, so the EU may seek better regulation of cross-border fertility to protect its citizens
from more unscrupulous operators.

The development of pharmaceutical regulation offers some insights – the requirement that a pharmaceutical product must have a marketing authorization before being placed on the market was a direct response to the Thalidomide scandal. Since then the regulatory framework has significantly expanded and harmonised. Just as there are good manufacturing practices for medicines, it is possible to imagine that one day there will be good clinical practices for cross-border healthcare.

Case study: UK

In the UK, the tension between services legally available, and services functionally accessible, provides both pull and push factors. In 2015, the UK became the first country to legalise mitochondrial replacement therapy (which allows genetic altering to avoid the risk of inherited disorders caused by gene mutations). Now that the Human Fertilisation and Embryology Authority (HFEA) has given the green light to at least one fertility clinic to perform the procedure, it could attract couples with mitochondrial issues from all over the world.

However, while the UK may be a global leader in fertility innovation, at local level, funding restrictions may push those that cannot access NHS funding to look for cheaper treatment options abroad. NHS funding for treatments is decided locally by Clinical Commissioning Groups (CCGs). National guidelines recommend that CCGs should fund three cycles of IVF or ICSI (including for single women and lesbian couples). In reality, few CCGs follow these recommendations. A small but growing number have even stopped funding IVF/ICSI completely.

Case study: France

Following the election of Emmanuel Macron, we are likely to see French policy-makers being asked to legislate on expanding access to fertility treatments to single women and lesbian couples. This may well happen by early 2019. Although a clear majority of the French population supports the change, it is likely to be a contentious process, with public consultations drawing strong representations from Catholic groups, as well as the ‘Manif pour tous’ movement, that was created to oppose the legalisation of same-sex marriage.

Currently, access is reimbursed through the public healthcare system, but is limited to heterosexual couples. Other women are required to travel abroad and pay out-of-pocket to access fertility services. It is notable that neighbouring Belgium has a thriving fertility market, and is likely to be benefiting from cross-border fertility tourism. Any legislative change is likely to affect these dynamics.

Case study: Germany

Last year, the German parliament passed same-sex marriage legislation quietly, with very little public controversy. However, the fertility framework remains some way behind. Non-married couples, single women and lesbian couples are not eligible for reimbursement. While they may access services privately, an additional barrier is created by the fact that there are limited sperm donations, as donors are not anonymous and may be subject to legal claims.

Same-sex marriage legislation can often be a marker for how liberal national frameworks governing fertility are. Spain and Belgium have been pioneers in both areas. Could the change to marriage in German legislation have a snowball effect on the fertility framework? While it is not in the coalition government’s four-year programme, neither was same-sex marriage under the previous agreement. With fertility rates declining fast and a continued focus on LGBT rights, it is not unrealistic to imagine changes. Should they happen, this would likely lead to a decline in the number of women leaving Germany to pay for fertility treatment abroad.

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