Italy is a yellow spot in the heritable editing map. Why?

Look at this map, from a detailed and up-to-date analysis published in the CRISPR Journal. It’s the global policy landscape on heritable human editing, i.e., modified embryos transferred to a uterus to initiate a pregnancy. Who would expect a catholic country like Italy to stand out as one of the very few countries not totally prohibiting such a controversial practice?

The yellow Italian Boot comes as a surprise in an almost all-red continent (Belgium is the other exception). Everybody knows that China gave birth to the CRISPR-babies Lulu and Nana in 2018, and Chinese scientists have published several papers on germline editing since 2015. Italian researchers didn’t even try. Why this regulatory anomaly, then?

Baylis et al. are (almost) right when they point out that Italy failed to ratified the Oviedo Convention, which clearly prohibits heritable human genome editing. Indeed the country signed the treaty and transposed it into national law but never completed the iter to make it fully operative. Therefore it is not so clear if Oviedo rules apply or not.

The decade long delay is probably because the treaty also covers another hot issue that many Italian politicians tried to avoid discussing for many years (advance healthcare directive, also known as living will). But this is only half an answer.

In 2004 Italy approved one of the strictest laws on assisted reproduction globally (law 40/2004), prohibiting things like heterologous fertilization and excluding fertile couples from IVF even if they were affected by genetic disorders that could be detected by preimplantation genetic diagnosis (PGD).

Article 13 of the law states that 1) Experimentations on human embryos are prohibited. 2) Clinical and experimental research on human embryos is permitted provided it pursues only therapeutic and diagnostic purposes, aimed at protecting the health and development of the embryo itself, and where alternatives are not available.

Why did Italian legislators leave this window open to heritable modification? CRISPR didn’t exist in 2004, so the whole matter seemed far ahead in the future. Probably admitting a theoretical therapeutic option for defective embryos was intended to compensate for the PGD practical prohibition somehow. Furthermore, embryonic stem cells were the hot topic of the time, and the attention mostly focused on the article’s effect of severely restricting stem cell research.

The paradoxical result is that the very law prohibiting many practices well accepted in most countries now seems to let the door open to CRISPR babies. I’m confident that nobody in Italy is interested in entering that door in the near future and that no ethical committee would give the go-ahead anyway. However, the whole story is a reminder that policymaking based on short-term political goals can backfire. Call it heterogony of ends, if you like it.

PS Sixteen years on, many of the IVF restrictions have been challenged in the courts and little remains of law 40/2004. Article 13, however, has survived the blow so far.

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