Private company paid for Mater Dei IVF, given shorter licence term

Malta’s government-financed fertility service at Mater Dei Hospital is a public-private partnership which has spent the last two years operating a lucrative operation, despite its government concession having expired for the last two years.

With unsatisfactory IVF rates that are raising questions about the success and efficiency of the Maltese government’s fertility programme, the private operator Cherubino was allowed to retain the concession without any formal contract extension or renewal.

And it is paid thousands for each IVF cycle by the State – after having won the €1.6 million tender to set up the unit back in 2014 – but its role is to collect the data from IVF treatments to present to the Embryo Protection Authority: it is the State that provides and pays the medical personnel running the unit.

And a plan in 2020 by the health ministry to outsource the government’s IVF programme, citing as reasons the need to improve success rates and bring down to zero the ovarian hyperstimulation (OHSS) cases that prevent fresh embryo transfers… was inexplicably never followed through.

In an analysis of annual embryology data and the fees charged to the health department by the Cherubino PPP, a picture emerges of an IVF programme which for the last two years has struggled to achieve positive results in spite of an annual €1.5 million financing by the government.

Upon analysing the rate of positive pregnancies from fresh embryo transfers, Malta’s data already falls below the European Society of Human Reproduction and Embryology (ESHRE) mean pregnancy rate of 39% (2017) across Europe.

From 2016 to 2020, the pregnancy rate appears to have dipped from 25% to 17%, and that is without excluding miscarriages in the first weeks of the pregnancy.

That’s a statistic that concerns fresh transfers of embryos, that is: a fertilised egg, that develops into a blastocyst over the course of five days, and is then implanted into a woman.

But there is a more serious figure that raises eyebrow in the Embryo Protection Authority’s latest annual report for 2020: the risk of OHSS at Mater Dei was of 50% – 51 cases out of 104 cycles – requiring all embryos to be frozen.

OHSS is the most common complication related to assisted reproduction – it is what happens to the female body when there is an exaggerated response to the excess hormones injected, required to stimulate the development of eggs in the ovaries, causing the ovaries to swell and become painful.

In general, OHSS is avoidable when 10-12 eggs produced; the risk becomes more present when over 15 eggs are produced.

If this “risk” rate is present for every other woman who undergoes IVF at Mater Dei, then questions start being raised about hospital procedures to stimulate women’s ovaries. Because that is a process that ultimately leads to the freeze-all option: a process that pays the Cherubino PPP more since it gets paid for each embryo frozen.

Across Europe, the reported incidence rate of OHSS is 0.2%. But that’s a comparison that the Superintendence for Public Health, Mater Dei, and the EPA are refusing.

The EPA claims it is reporting “risk” of OHSS, not “incidence”. Therefore it sees no need to investigate Mater Dei’s ‘freeze all’ option in the 50% cases of the 2020 cycles.

The Superintendence, which actually licences the Cherubino PPP, insists there were no reports for “serious adverse events of OHSS”. Additionally, Mater Dei says it has achieved a zero-OHSS clinic in the last three years, through “meticulous clinical vetting”.

That does not explain why Mater Dei’s doctors are reporting a high “risk” rate in the first place in half of the 2020 cycles, which meant suspending the embryo transfer until the mother’s hormone levels are restored. In the meantime, all embryos and eggs are frozen.

Frozen embryos at a fee

When eggs are harvested from a woman, Maltese law will allow just five eggs to be fertilised with sperm. A typical harvest is of 10-12 eggs. The excess eggs are frozen.

Not all of the five fertilised eggs will develop into good quality embryos. Only a maximum two embryos will be implanted at any one time in a woman. The rest of the embryos will be frozen.

In 2014, Cherubino was awarded the €1.57 million contract to set up the theatre, laboratory and storage areas that complemented MDH’s infrastructure. But in this PPP model, it is the government provides the medical human resources for the provision of the IVF service, not the Cherubino licensee.

Cherubino provides clerical services to process the IVF lab data for the EPA apart from paying licence fees. For every single clinical process that takes place by government doctors, Cherubino also gets paid: for example, it is paid €1,500 for each embryo that gets frozen.

Cherubino’s fees are charged across each step of the IVF service: a standard service fee of €1,900, then €800 to freeze the surplus eggs, an additional €1,500 for each embryo frozen, again €1,500 to thaw the frozen embryos, and €900 to transfer them.

In a normal cycle, five eggs will get fertilised and perhaps produce three good quality embryos. Cherubino will be paid €1,900, and €800 to freeze surplus eggs harvested from the mother, but also €1,900 to freeze one embryo – only a maximum of two embryos are implanted at a time.

But what happens when the risk of OHSS interrupts a fresh transfer of embryos?

Now the cost climbs to €1,900 for service provision and €800 for the freezing of surplus eggs; the freezing of three embryos is at €4,500, thawing them will cost €1,500 – twice, given that only two embryos at a time can be implanted – and a thawed cycle for €900: €11,100.

These are fees which are over and above the human resource cost financed by the State, which spent in total €1.43 million on the IVF programme in 2020, €1.6 million in 2021, and in 2022, is expected to spend €2.5 million.

And ultimately the measure of success for the government IVF programme are the pregnancy rates and live births from the fresh and frozen embryo transfers.

Contract expires, but PPP is retained: why?

The Cherubino PPP at Mater Dei was inexplicably allowed to continue its operation since 2020 without a proper contract. The health authorities did not explain why.

The initial concession first granted in 2014 has expired since then, a state of affairs that however does not affect its licensing by the Superintendence which issued licences for Cherubino in April 2015, 2017, 2020, and finally in April 2022 – but only for seven months.

This short licensing period appears to be the prologue to the end of Cherubino’s PPP at Mater Dei, which has announced a transition plan for the hospital to regain control of the IVF clinic.

But part the reason also lies in an important document issued back in April 2020 when Cherubino was last licensed: a market consultation calling for the upgrade of the Mater Dei clinic “by moving to a new fully licenced clinic outside of MDH.”

The document shows the intention of the health authorities to upgrade the MDH clinic’s dated equipment, and to provide the same services from “a bigger, fully functional and licensed facility”.

But apart from moving out of Mater Dei’s under-performing facility, the health authorities’ awareness of the Mater Dei limitations of were made clear enough: because the document requested interested parties to show how they could “guarantee… minimal near to zero OHSS cases”; and then “reduce to zero the waiting list” by performing more weekly fertility cycles, and even “guarantee success of IVF cycles, wherein the interested party will only be paid for successful cycles carried out. Cycles that are unsuccessful will not be paid for.”

What the ministry wanted, was not a repeat of the Cherubino PPP.