Is the HFEA Traffic Light system Enough?
As we have mentioned in previous articles namely:
IVF treatment addons aren’t regulated in the same way as medications and as such it’s vital that patients ask specific questions and completely understand the treatment and evidence base. This means that the patient can give informed consent and understand whether treatment is the best option for their specific set of circumstances and diagnoses.
The HFEA (Human Fertilisation and Embryology Authority) are the UK regulatory body for fertility and IVF clinics in the UK, so what are they doing to ensure patients are protected?
What is the HFEA Traffic light system?
This was set up in response to outcry from the public and the media regarding mis-selling and emotional selling of IVF add-ons to people in emotionally vulnerable states due to their infertility.
Many mainstream articles jumped on the bandwagon criticising individual clinics, doctors and the HFEA. This coupled with social media which often uses a few anecdotes of ‘success’ as data driven evidence of a beneficial treatment.
This all led to the creation of the HFEA traffic light system.
The HFEA have devised a traffic light system to ‘rate’ treatments in addition to the normal IVF treatment you can find that here.
The image below shows the page and the level of information you are given. Their guide states:
“We use an amber symbol where there is a small or conflicting body of evidence, which means further research is still required and the technique cannot be recommended for routine use.
A treatment is red if there is no evidence to show that it is effective and safe.
Currently none of the treatment add-ons we have assessed have been rated green. This means that we don’t think any of these techniques should be used routinely.”
So, if it’s red then there is no evidence and amber still means that the evidence is still not robust. Each of the treatments listed only has about 150 words with a very quick overview of the treatment, any risks specific to the treatment and tiny section on the research.
The question is; is this enough?
Why did the HFEA traffic light system need to be set up in the first place?
Ultimately the HFEA regulate the IVF and assisted reproduction treatment industry. They issue licences and they undertake audits.
Credit where credit is due the HFEA have done a superb job at improving laboratory practices, processes, paperwork and reducing multiples and OHSS instances from IVF.
They have a specific remit from the government which covers these areas, however they don’t have a remit which covers what private clinics can offer in terms of additional treatments and they don’t have any influence over the costs involved with any treatments.
When the above is coupled with the internet being dominated by information from the U.S. IVF industry where these technologies are much more commonplace. It leads to misinformation being spread through anecdotal stories and commercial marketing.
Which ultimately is increasing the use of these IVF add-on treatments in the UK.
Clinics have said that the reason they are offering these additional treatments is due to “patient pressure”
A HFEA study found that 70% of clinics now offer some form of IVF addon treatment with little evidence base to support it with the greatest prevalence being in the private London clinics; to which I ask you this…
Is it a coincidence that the area with the most available income and the wealthiest patients is the area with the highest instance of non-evidence-based IVF treatment add-ons?
Which if the answer is it’s not a coincidence, I struggle to believe that it’s due to “patient pressure”.
In 2018, the government took a great step through the HFEA issuing a code of conduct which require doctors to explain to patients whether there is any clinical evidence to support extra procedures being offered.
However, what’s important to note is that at the current time this is yet to be audited! If something isn’t policed, you can’t expect compliance, this leaves patients vulnerable to emotional selling and glossy marketing materials.
This traffic light system was set up to provide information to patients to help them understand the treatments, risks and make an informed decision.
Is the HFEA traffic light system sufficient to help UK patients make good decisions?
Our humble opinion is…
Allow us to explain why.
As we have already stated the internet is a big place, commercial IVF clinics especially those from the U.S. and ever-growing in the UK have big marketing budgets!
As such the amount of inaccurate and misleading information surrounding patients is deafening, you can’t see the wood for the trees. This issue is further exacerbated when the institutions we trust the NHS and our regulators don’t have good detailed quality information which helps patient make informed decisions about the treatments they need.
They have taken the first step. What improvements would we like to see:-
- They need to provide links to the appropriate evidence especially when they rate one as amber.
- They need to distil the latest research into lay terms to allow patients to quickly absorb complex data.
- They need to discuss the commercial element of IVF in the UK and how this is in conflict with doing the best by patients
- They need to do an immediate audit of all clinics providing these IVF add-on treatments – With results published immediately for patients to see.
- They should enforce that all IVF treatment add-ons with no evidence explicitly state that in a transparent and obvious clear language on all website and printed marketing material, patient information, consent forms and treatment guides.
- They need more details on the treatments and the risks and unknown potential areas of risks – E.G. the impact of light exposure on embryos from time-lapse imaging.
- I know they issue price guides that a complete cycle should be between 3-5k but they should provide breakdown of costs for technology and additional treatments to give patients evidence of getting value for money.
- We personally believe that they should be able to give licence restrictions to clinics who give treatments which aren’t determined by patients’ specific diagnoses.
- They should supply information on additional testing that a lot of clinics ‘Demand’ or advise before starting IVF such as AMH, immunology panels etc. If a patient’s history doesn’t demand them and there is little evidence to support testing, it’s just another cost without much benefit.
- More information should be offered on the differing IVF protocols offered in the UK and specific reasons as to why they should differ for specific circumstances.
- Supply a support line for patients to call to ask specific questions about clinics, treatments and addons.
- Release all investigation findings into complaints about mis-selling or inappropriate treatments especially for unproven IVF add-ons.
- Be more proactive in terms of social media, PR and marketing of accurate IVF add-on information rather than reactive and defensive.
These are just some of our initial thoughts. But ultimately the government need to broaden the regulatory powers of the HFEA to allow them to properly ‘regulate’ the IVF industry before it becomes more of a commercial enterprise as it can be in other countries than a patient focused medical treatment.
But until that the HFEA shouldn’t be shy about giving patients all the information they need, and I mean ALL the information to make informed decisions. They should name and shame, audit and be completely transparent with people and keep their information up to date at all times.
At the moment it is down to other patients, NHS doctors and consultants and advocates for the fertility industry to fight against misinformation and help people make informed decisions…
That’s not how it should be!
Let us know your thoughts on the HFEA traffic light system.