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Five Further Member State Inspectorates Recognised under EU - US Mutual Recognition System for Medicines

  • 03/12/2018
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The Agreement on Mutual Recognition between the European Union and the United States of America continues its roll-out in the realm of pharmaceutical inspections. On two separate occasions in November 2018, the US Food and Drug Administration (“FDA”) added 5 new EU Member States to its list of countries which it considers to have capable inspectorates to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that observed in the US. These Member States are Belgium, Denmark, Estonia, Finland and Latvia. The updated list of in total 20 Member States whose inspection results the FDA considers can replace its own inspections can be found here:
https://www.fda.gov/internationalprograms/agreements/ucm598735.htm.
 
The EU and the US thus seem to be on track to have all EU Member States recognised as capable of carrying out pharmaceutical inspections by 15 July 2019. For its part, the FDA had already been earmarked as a capable inspectorate on 1 November 2017.

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    • 18/02/2019
    • Articles

    Belgium - Bill regarding Reimbursement of Pharmaceutical Specialties

    On 7 February 2019, the federal government submitted a bill regarding the reimbursement of pharmaceutical specialties to the federal chamber of representatives (Bill 54 3535/001) (the “Bill”). The Bill provides for the following saving measures designed to contain the pharmaceutical budget: • More significant price decrease on the basis of turnover for medicines that have benefited from reimbursement for 15 years (“volume cliff”) (There will be a staggered system providing for a range of turnover figures between EUR 1.5 million and EUR 70 million). • Extension of maximum price (“ceiling price”) system from medicines delivered in the community pharmacy to medicines delivered in the hospital pharmacy. • Start of cheapest prescriptions and prescription quota systems in hospital environment. • Further limitation of invoicing level open to hospitals to 85% of the official price. This system applies to a segment of the medicines open to competition, namely medicines falling under the reference reimbursement system. It is designed to channel to the public purse part of the savings made by hospitals from discounts obtained from their suppliers. • Adaptation of definition of “cheap prescription”. • Medicines in reimbursement category F will now also be made subject to the price cuts applying to “old” medicines (reimbursed for 12 or 15 years). The reimbursement basis of medicines of category F is a flat fee per indication, treatment or analysis. • Definition of specific compensating levy for 2019 (“compenserende heffing”/”cotisation compensatoire”). • Limited increase of pricing transparency for medicines subject to Managed Entry Agreements: Members of the General Council (the top body within the Public Institute for Illness and Disability Insurance) and of the Auditing Court (which verifies and oversees the spending of the government) will be given access to aggregated price information (as a rule on the ATC1 level, i.e., the top level of the Anatomical Therapeutic Chemical Classification System of medicines). The qualifying members will be required to sign a non-disclosure agreement. The government is apparently confident that the Bill will garner a majority in the chamber. The Bill can be found here:

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    • 12/02/2019
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    European Parliament Raises Issue of Alleged Excessive Pricing of Orphan Medicine

    In a response to two parliamentary questions of 6 February 2019, the member of the European Commission (the “Commission”) responsible for health and food safety Vytenis Andriukaitis announced that the case of chenodeoxycholic acid Leadiant (“CDCA”) will be taken on board in the European Commission’s ongoing assessment of the rules governing orphan medicines. According to the Commissioner, the case is also likely to inform competition investigations of possible excess pricing cases (see attached parliamentary questions and answer). CDCA is indicated for the treatment of patients afflicted with cerebrotendinous xanthomatosis, a rare metabolic disorder. These patients are unable to produce enough of the primary bile acid chenodeoxycholic acid. When primary bile acids are lacking, the body produces abnormal bile acids and other substances instead which accumulate throughout the body, causing damage. Because the number of patients with this condition is very limited, the disease is considered ‘rare’, and CDCA was designated as an orphan medicine in December 2014. CDCA is also a hybrid medicine in that it is similar to a reference medicine, Xenbilox, with the same active substance. However, Xenbilox differs from CDCA in that it is only authorised to dissolve cholesterol gallstones, an indication in use since the 1970s under the name Chenofalk. Leadiant Biosciences (“LB”), the marketing authorisation holder of CDCA, is accused of having monopolised chenodeoxycholic acid and then acquired the exclusive marketing rights associated with the orphan medicine designation of CDCA. The price for the medicine would have gone up considerably. According to one of the Members of Parliament who raised the issue, LB now charges EUR 140 per pill in specific markets, while the medicine cost 30 eurocents per pill when it was still sold as an anti-gallstone medicine. The accusation of excessive pricing is understood to be under review by the Dutch competition authority. The case raises a range of issues and themes that have recently come to the fore in political discussions across the European Union, including the status of orphan medicines; the tackling of excessive prices under the competition rules (the European Commission has not only started a procedure of its own in another file, but says it also supports various efforts of national competition authorities in that area); and possible cooperation among Member States with regard to medicine pricing and reimbursement, a controversial subject which the Commission stresses belongs to the exclusive competencies of the individual Member States.

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    • 30/01/2019
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    Belgium - Liberalisation of distribution channel for medical devices

    A Royal Decree of 18 December 2018 regarding the liberalisation of the distribution channel for medical devices (the “Royal Decree”) was published in the Belgian Official Journal on 28 January 2019. The Royal Decree abolishes a number of provisions for the purpose of allowing supermarkets and other stores to also sell, as from 7 February 2019, certain medical devices that until now could only be sold through pharmacies (these devices are listed in the Royal Decree of 18 March 1999 on medical devices, annex XIII, items 1.1 through 1.5). Belgium thus seeks conformity with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices pursuant to which “Member States shall not refuse, prohibit or restrict the making available on the market or putting into service within their territory of devices which comply with the requirements of this Regulation” (Article 24). The Royal Decree applies to all medical devices that are available without prescription. In practice, it is expected to impact mainly the distribution of sterile medical devices, such as tubes and band aids, which until now could be sold only through pharmacies. By contrast, the sale of medical devices available on prescription remains limited to pharmacies. The supermarkets and other stores that will sell medical devices under the Royal Decree will have to meet the same quality, security and traceability criteria as the pharmacies and will need to register in advance with the Federal Agency for Medicines and Health Products. According to the Minister of Public Health, Maggie De Block, foreign examples show a marked price decrease of medical devices when these are also made available outside the pharmacy channel. The Minister hopes that the Royal Decree will have the same effect on pricing. Here goes a link to the Dutch and French versions of the Royal Decree of 18 December 2018 : Royal Decree of 18 December 2018

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