[Ip-health] Altroconsumo: Avastin-Lucentis: the Council of State confirms the sentences for Roche and Novartis

Thiru Balasubramaniam thiru at keionline.org
Thu Jul 18 02:43:51 PDT 2019


Avastin-Lucentis: the Council of State confirms the sentences for Roche and

16 lug 2019

This puts an end to a sequence of events starting back in 2009, which has
seen Altroconsumo at the forefront since the very beginning. The Council of
State has today marked the point of no return: Roche and Novartis are
guilty of unlawful collusion, to the detriment of patients and the national
health system.

Now we hope that appeals from the regions will get underway.

There is no longer any doubt regarding the matter: Roche and Novartis put
an anti-competitive agreement in place to artificially favour the sale of
Lucentis (Novartis) to the detriment of Avastin (Roche), both effective
drugs in treating exudative maculophaty, but one (Lucentis) considerably
more expensive than the other (Avastin).

“It took 10 years and 4 different levels of judgement – declared Ivo
Tarantino, Altroconsumo External Relations Manager – but in the end the
tireless commitment that saw us set to work straight away to protect
consumers has paid off. Over the past few years, there have been many
attempts by the two companies to turn the tables on the matter, with
extreme technicalities that had nothing to do with the heart of the issue
in question: patients that were denied access to treatment for a disease as
serious as maculopathy and the health service which had to pay tens of
millions of euros due to the heinous unlawful collusion of the two
pharmaceutical companies.”

These are the stages of the story, which Altroconsumo has followed closely
in the interest of patients and consumers as a whole

Avastin and Lucentis are medicines developed by Genentech, a company
belonging to the Roche group. Genentech entrusted the commercial
exploitation of Lucentis to the Novartis group through a licence agreement.
Roche marketed Avastin.

Lucentis is authorised for the treatment of ophthalmic diseases. As it
costs less than Lucentis, Avastin, equally effective in retinal diseases,
although only authorised for the treatment of tumours, was also widely used
for the treatment of ophthalmic diseases (off label use):

between 2009 and 2012, the Italian Medicines Agency (Aifa) gradually
suspended all uses of Avastin permitted under the reimbursement regime.
Prescriptions moved over to Lucentis. Roche and Novartis agreed, in fact,
to artificially differentiate between the two drugs, mainly trying to prove
that Avastin posed greater risks, against the evidence coming from clinical
experience and from all independent studies;
Avastin could no longer be reimbursed by the Health Service and patients no
longer had a treatment. Or they were forced to pay for it privately out of
their own pocket if they had the means;
the additional cost for the National Health Service is calculated at €45
million for 2012 alone;
·on 5 May 2014, the Antitrust Authority fined the two pharmaceutical
companies at the end of a proceeding initiated in 2013, also after
petitions from the Society of Italian Ophthalmologists and other bodies and
organisations, including Altroconsumo;
the exemplary fine (over €90 million to both pharmaceutical companies) is
the first of several pieces in the puzzle to achieve transparency on the
matter and to ascertain the responsibilities of those who took advantage of
the health of particularly weak and needy consumers. Altroconsumo also sent
a petition to the Public Prosecutor’s Office in Rome, in Turin, and to the
Court of Auditors;
the two companies immediately filed an appeal with the Regional
Administrative Court (TAR) in Lazio, which however rejected it in November

Roche and Novartis then involved the Council of State which referred the
case to the European Court of Justice. On 23 January 2018, the Court of
Luxembourg responded to the preliminary questions presented by the Council
of State, essentially confirming the validity of the Antitrust Authority’s
findings and conclusions and referring the case back to the Italian
judicial system for the final act of this long process.

Today, the final act has been played out and does justice to one of the
most blatant cases of unlawful actions to the detriment of consumers, even
more serious if we consider thatthe two pharmaceutical companies took
advantage of the health of particularly weak and needy consumers. “We are
obviously satisfied with the sentence and proud of having in some way acted
as one of the instigators, but this isn’t the end of the road for us –
concludes Ivo Tarantino. Altroconsumo in fact reaffirms the right/duty of
the Regions, now that the sentence is final, to request compensation for
the greater expense incurred over the years for the purchase of the more
expensive drug.”

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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