Mutual recognition procedure (whatever that is!)

Given the issues with MercuryPharma Liothyronine (cost, Yellow Card reports, etc.), I was prompted to look again at the MHRA site regarding product licences. Must have been quite a while since I looked - much has changed from what I remember. (Or is that my memory playing tricks?) Most particularly, there is something called the Mutual recognition procedure.

My take on it is that a medicine that has been granted a licence in one EU country can apply for another country to grant a licence simply because it already has one in another EU country. Obviously this is not automatic. There will be checks. Perhaps not all national approval systems are equally trusted, etc. But, at heart, it might indeed be much simpler for a liothyronine producer in another EU country to get a UK product licence.

The most obvious company, it appears to me, is Sanofi - given that in France it sells Cynomel, and in Germany, under its Sanofi Deutschland name (formerly Henning) it sells Thybon. Sanofi already has a UK presence.

We don't know what is happening behind the scenes. Is it possible that this is in part why MercuryPharma are doing what they are to the price? Rake in as much as they can before the competitor(s) come to market? Doesn't in any way excuse or justify their actions, but just might help to explain them. What they have done otherwise looks like market suicide whereas this would be execution by a competitor.

Or am I simply an optimist?

Mutual recognition procedure (including repeat use)

Use the mutual recognition procedure when your product already has a national licence in at least 1 EU country, and you want to market it in more EU countries. The principle is that the countries you wish to add recognise the national licence(s) already granted.

gov.uk/guidance/apply-for-a...

8 Replies

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  • Helvella,

    Hopefully competitors bringing Liothyronine to the UK market (if it happens) won't use Mercury Pharma's pricing as a benchmark to set their costs.

    To see just how UK T3 cost compares with other countries Sheila of TPA has listed the following:

    Sweden - 100 tablets of L-T3 = £21.10

    Finland - 100 tablets of L-T3 = £15.81

    Norway - 100 tablets of L-T3 20mcgs – NOK 254.50 = 27.51€ = £21.65

    Denmark - 100 tablets of L-T3 20mcgs – Thybon 20 Henning = DKK 190 = 25.53€ = £20.09

    Germany - 100 tablets of L-T3 20mcgs -30.15€

    Turkey - 100 tablets of L-T3 – Tiromel = £1.25 (info. from private correspondence)

    UK - 100 tablets of T3 - Liothyronine = £922.44 (based on 28 tablets at £256.20)

  • Perhaps the competitor is (partially) behind the MP price rise - they will look competitive even if grossly over-charging. An ideal entry to the UK market - especially if MP are quitting anyway. :-(

    [All speculation - don't take any of this as factual.]

  • This is unbelievable and surely totally unethical! I am completely gobsmacked! Greed seems to dictate everything in business nowadays. Who actually pays initially for the T3 prescribed within the NHS? It must be such a complicated chain. Why can't it be brought it from abroad...at least while we are in th EU!! Nobody should cowtow to a profiteering UK monopolist?

  • I'm sure you've heard about the obscene mark ups in the U.S. Many of them are cancer drugs but I looked up a drug for SIBO which sells for over $1,000. In Canada, it can be purchased for $152. The government has adopted a laissez-faire attitude toward drug producers. I'm sure there is a corrupt angle behind it.

  • It certainly looks like it is the same underlying story from around the world. Even if individual medicines show a patchwork of prices - high in some; low in others.

    The story from the UK/NHS perspective is that our NHS management, the civil servants in the Department of Health and the politicians have signally failed to react to this. In the case of liothyronine the evidence is as clear as ever it could be. Especially that within the same major trading block - the EU - we see absolute bargain basement prices as well. (We don't have to consider China, third world, etc. to get low priced examples.) It should have been picked up, investigated, challenged, as the price shot up. The legal and commercial framework should have been changed to prevent this obscene exploitation.

  • I suspect as posted yesterday that when Cinven bought Mercury they upped the price to make it hugely profitable in order to sell on at inflated price.Typical private equity trick.

    My MP has suggested I might like to write another letter to the Minister and Helvella & Sheila's information will be very useful.We should all write to uur MP.

  • When did Cinven buy Mercury? I have been having such issues with my medication, its making me really ill again

  • As far as i can make out 2012 then sold to Cocordia in October 2015.

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