Malta’s government-funded fertility service at Mater Dei Hospital is a public-private partnership that has spent the past two years running a lucrative operation, although its government concession expired for the past two years.
With unsatisfactory IVF rates raising questions about the success and effectiveness of the Maltese government’s fertility programme, private operator Cherubino was allowed to retain the concession without a formal contract extension or renewal.
And he’s paid thousands for each IVF cycle by the state – after winning the €1.6 million tender to create the unit in 2014 – but his role is to collect data from IVF treatments to be presented to the Embryo Protection Authority: it is the State that provides and remunerates the medical personnel who run the unit.
And a plan in 2020 by the Ministry of Health to outsource the government’s IVF program, citing as reasons the need to improve success rates and reduce to zero cases of ovarian hyperstimulation (OHS) that prevent transfers of ‘fresh embryos… was inexplicably never tracked.
From the analysis of annual embryology data and the fees billed to the Ministry of Health by PPP Cherubino, the picture emerges of an IVF program which, for two years, has struggled to obtain positive results despite funding annual amount of 1.5 million euros by the government.
After analyzing the rate of positive pregnancies from fresh embryo transfers, Malta’s data is already below the European Society of Human Reproduction and Embryology (ESHRE) average pregnancy rate of 39% (2017) in all Europe.
From 2016 to 2020, the pregnancy rate would have fallen from 25% to 17%, and this without excluding miscarriages in the first weeks of pregnancy.
This is a statistic that concerns fresh embryo transfers, that is: a fertilized egg, which develops into a blastocyst in five days, and which is then implanted in a woman.
But there is a more serious figure that raises eyebrows in the latest 2020 annual report from the Embryo Protection Authority: the risk of OHSS in Mater Dei was 50% – 51 cases out of 104 cycles – requiring the freezing of all embryos.
OHSS is the most common complication related to assisted reproduction – it’s what happens to a woman’s body when there is an over-response to the excess hormones injected, needed to stimulate egg development in the ovaries, causing swelling and pain in the ovaries.
In general, OHSS is preventable when 10-12 eggs are produced; the risk becomes more present when more than 15 eggs are produced.
If this “risk” rate is present for all other women undergoing IVF at Mater Dei, then questions begin to arise about hospital procedures for stimulating women’s ovaries. Because it’s a process that ultimately leads to the total freezing option: a process that pays the Cherubino PPP more since it is paid for each frozen embryo.
Across Europe, the reported incidence rate of OHSS is 0.2%. But it’s a comparison that the superintendence of public health, Mater Dei, and the EPA deny.
The EPA says it reports the “risk” of OHSS, not the “incidence.” Therefore, he sees no need to investigate the “freeze everything” option of Mater Dei in the 50% of the cases of the 2020 cycles.
The superintendency, which actually authorizes PPP Cherubino, insists there have been no reports for “serious adverse events from OHSS.” Additionally, Mater Dei says it has achieved an SST-free clinic in the past three years, through “meticulous clinical verification.”
This does not explain why the doctors at Mater Dei report a high “risk” rate in the first place in the half of 2020 cycles, which meant withholding embryo transfer until hormone levels of the mother are restored. In the meantime, all embryos and eggs are frozen.
Paid frozen embryos
When eggs are harvested from a woman, Maltese law only allows five eggs to be fertilized with sperm. A typical harvest is 10-12 eggs. Surplus eggs are frozen.
Not all five fertilized eggs will develop into good quality embryos. Only a maximum of two embryos will be implanted at a time in a woman. The rest of the embryos will be frozen.
In 2014, Cherubino won the 1.57 million euro contract to fit out the theatre, laboratory and storage areas that complete MDH’s infrastructure. But in this PPP model, it is the government that provides the medical human resources for the provision of the IVF service, not the Cherubino licensee.
Cherubino provides office services to process IVF lab data for the EPA in addition to paying license fees. For each clinical process carried out by government doctors, Cherubino is also paid: for example, he is paid €1,500 for each frozen embryo.
Cherubino fees are charged at each stage of the IVF service: a standard service fee of €1,900, then €800 to freeze excess eggs, an additional €1,500 for each frozen embryo, another €1,500 to thaw embryos frozen, and €900 to transfer them.
In a normal cycle, five eggs will be fertilized and possibly produce three good quality embryos. Cherubino will receive €1,900, and €800 to freeze excess eggs harvested from the mother, but also €1,900 to freeze an embryo – only a maximum of two embryos are implanted at a time.
But what happens when the risk of OHSS interrupts a new embryo transfer?
Now, the cost rises to €1,900 for the provision of the service and €800 for freezing surplus eggs; freezing three embryos is €4,500, thawing them will cost €1,500 – double that, given that only two embryos can be implanted at a time – and one thawing cycle is €900: €11,100.
These are fees that are added to the cost of human resources financed by the State, which spent a total of €1.43 million for the IVF program in 2020, €1.6 million in 2021 and in 2022, should spend €2.5 million.
And finally, the measure of the success of the government’s IVF program is the pregnancy rate and live births from fresh and frozen embryo transfers.
The contract expires, but the PPP is retained: why?
The Cherubino PPP at Mater Dei has been inexplicably allowed to continue operations since 2020 without a formal contract. Health authorities have not explained why.
The initial concession first granted in 2014 has since expired, a situation which however does not affect its licensing by the Superintendence which issued licenses for Cherubino in April 2015, 2017, 2020, and finally in April 2022 – but only for seven months.
This short license period appears to be the prologue to the end of Cherubino’s PPP at Mater Dei, which announced a transition plan for the hospital to regain control of the IVF clinic.
But part of the reason also lies in an important document published in April 2020 during Cherubino’s last license: a market consultation calling for the upgrade of the Mater Dei clinic “by moving to a new fully licensed clinic outside of the MDH”.
The document shows the intention of the health authorities to upgrade the outdated equipment of the MDH clinic and provide the same services from “a larger, fully functional and licensed facility”.
But aside from leaving the underperforming Mater Dei facility, the health authorities’ awareness of Mater Dei’s limitations was clear enough: because the document asked interested parties to show how they could “guarantee … a minimum close to zero cases of OHSS”. ; then “reduce the waiting list to zero” by performing more weekly fertility cycles, and even “guarantee the success of IVF cycles, where the interested party will only be paid for the successful cycles performed”. Failed cycles will not be paid.
What the ministry wanted was not a repeat of the PPP Cherubino.