EU Casts a Wary Eye on Drugmaker Dealings

     (CN) – European regulators warned Johnson & Johnson and Novartis against reaching an agreement that could harm consumers – part of their larger probe into Big Pharma.
     Regulators filed an official statement of objections over an agreement between the Dutch subsidiaries of Johnson & Johnson and Switzerland-based Novartis that effectively kept the generic version of painkiller fentanyl from the market for 17 months, the European Commission said Thursday.
     An objection is the second step in the commission’s investigation process.
     Fentanyl is 100 times more potent than morphine and is used to treat patients with severe pain.
     In the United States, the Food and Drug Administration has approved several forms of the drug – including the brand names Actiq and Onsolis – for the treatment of breakthrough cancer pain.
     “If our preliminary conclusions are confirmed, the Dutch subsidiaries of Johnson & Johnson and Novartis entered into a so-called ‘co-promotion’ agreement to avoid competing against each other, depriving users of fentanyl in the Netherlands from access to a cheaper pain killer,” Joaquin Almunia, who heads competition policy for the commission, said in a statement. “The commission is determined to fight undue delays in the market entry of generic medicines so that European citizens have access to affordable healthcare. It is also important to make sure that pharmaceutical companies do not free ride our welfare state and health insurance systems, especially in this period of constraints on public spending.”
     J&J subsidiary Janssen-Cilag kept a generic version of the fentanyl patch out of the Dutch market by making a 2005 deal with generic drugmaker Sandoz, a branch of Novartis.
     Under the scheme, Janssen-Cilag made monthly payments to Sandoz – which delayed manufacture of generic fentanyl – for 17 months, keeping prices for the painkiller artificially high.
     Such agreements are an ongoing problem in the EU, according to a second commission finding . In the last year, regulators say that they have sent statement of objections to more than 14 pharmaceutical companies that have entered into similar schemes.
     Specifically, Danish company Lundbeck and several generic competitors agreed to deny the market from cheaper forms of citalopram – used to treat various forms of depression and anxiety. In addition to direct payments, Lundbeck bought generic citalopgram from at least four manufacturers and destroyed them, the commission said.
     Les Laboratoires Servier made similar agreements with generic drugmakers to keep perindopril, an ACE inhibitor, from entering markets across the EU. In addition to cash payments, regulators accuse the company – the second-largest French pharmaceutical manufacturer in the world – of acquiring patents in an effort to shut out its competitors.
     “Such practices, if established, would be likely to cause significant consumer harm as national health services or insurance schemes are then forced to continue paying for the more expensive patent protected versions of a medicine when, absent the practices, cheaper generic medicines would have been available earlier,” the commission said.
     Regulators hope that two measures under legislative and member state consideration will speed cheaper versions of medication to the marketplace. The commission proposed faster access to medicine by streamlining and reducing the duration of pricing and reimbursement in March 2012.
     It also hopes that an overhaul of the patent system in the EU – and a dedicated patent court in 2014 – will improve what it calls “a fragmented patent system which currently causes legal uncertainty in patent disputes all over the EU.”

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