RAPS News: Europe Online

December 2011

• EU Court Backs Longer Patent Protection for Multidisease Drugs

  Bloomberg

  The EU's highest court supported extended patent protection for drugs and vaccines effective against multiple diseases, helping clarify the issue of how to interpret EU rules on so-called Supplementary Protection Certificates (SPCs), or extended patent protection, for multidisease drugs and vaccines. The added value of even a few additional months of protection for a blockbuster drug is quite significant, said Jonathan Radcliffe, a lawyer at Mayer Brown LLP. The EU court "confirmed a relatively broad scope of SPC protection covering all combinations of a particular active ingredient with others, providing that the active ingredient is supported by the underlying patent," says Marks & Clerk Solicitors Attorney Will James, adding that the circumstances for being unable to obtain an SPC are now clearer. Extended patent protection will help drugmakers at a time when generic competition is rapidly increasing. The extended patent protection provided by an SPC can only be given to the company that owns the patent on a drug's active ingredient. The case in question arose after a unit of Medeva Holdings, which belongs to Celltech Pharma Europe, was refused an SPC in the UK for multidisease vaccines that contained a patented and non-patented active ingredient. The court clarified that only one SPC can be given per patent, which could have a major effect on the strategies life-sciences companies will use, according to Radcliffe.

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• European Medicines Agency to Revise Biosimilars Guideline

  PMLiVE

  The European Medicines Agency (EMA) is planning to update its guideline on biosimilars. The existing guideline, which went into effect in 2005 before biosimilars were marketed in the EU, was intended to introduce the idea of biosimilars and outline basic principles for applications. However, in a paper released for consultation, EMA's Committee for Medicinal Products for Human Use (CHMP) says many terms are being used for "biosimilar" or "similar biological medicinal product," and are often used inappropriately. The committee says it may be wise to explore whether a definition for biosimilar is needed beyond the EU legislation and the relevant CHMP guidance. CHMP recommends a variety of issues that should be considered when updating the guideline, including clarifying the principles of biosimilarity so readers can easily understand the goal of a biosimilar development program. The committee also calls for a discussion on whether it is feasible to follow the legal basis for generics for some biological products, and states an assessment may be necessary to clarify whether there are exceptional circumstances in which a biosimilar could be authorised based on a bioequivalence study alone. There are specific elements of the existing guideline that need additional discussion and refinement, according to CHMP, including efficacy and safety aspects, language about pharmaceutical form, strength and route of administration, and references to multiple guidelines.

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• European Commission Consults on Unique Identifiers for Medicines

  PMLiVE

  The European Commission (EC) is considering new pharmaceutical packaging elements to prevent counterfeit drugs from entering the supply chain. A concept paper from the EC describes various options to fight counterfeit drugs by using a unique identifier, like a barcode, on the outer packaging of medicines. The effort complements the EU falsified medicines legislation that obliges the Commission to adopt implementing legislation establishing a unique identifier safety feature. Under the directive, the unique identifier must allow for verification of a medicinal product's authenticity and for identifying individual packs. To accomplish this, a random serialization number must be on the packaging on a barcode or other carrier. That number can then be checked against a repositories system for verification. The Commission is requesting industry feedback on whether the technical solution for the serialisation number and container should be decided by each manufacturer or whether it should be standardised through regulation. The Commissions say that, at a minimum, the number should have a manufacturer product code and a pack number, but leaves other details like batch number, expiration date and national reimbursement number optional. The paper asks for comments on the benefits and disadvantages of linear barcodes, two-dimensional barcodes and radio-frequency identification. The Commission wants to determine where barcode verification should occur—at the dispensing point alone or additionally at points throughout the supply chain. The paper also asks for stakeholder input on the logistics of launching and maintaining the repositories system and how to determine which products should be exempt from the requirements.

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• UK Drug Supply Shortages Dispute Continues; Health Minister Makes Statement

  Global Insight

  UK Health Minister Simon Burns has taken a clear position on the UK's drug supply shortages dispute by telling the House of Commons that the existing system of best practice guidance is a better option than introducing mandatory supply regulations. Burns recently told members of Parliament that parallel trade is legal and has been beneficial to the UK in the past, but that he is cautious about following that path as it would significantly increase regulation on the industry and drive up costs. Burns argues that mandatory supply requirements for pharmaceutical companies and wholesalers are unlikely to be introduced in the UK, unless Parliament pushes for changes in regulation following the completion of a review or if drug shortages worsen significantly. Pharmacies and wholesalers have expressed concerns about shortages of some medicines, which are being blamed on pharmaceutical company supply quotas in response to parallel exports from the UK to other EU countries that have higher prices due to exchange-rate effects. Calls for increased regulation of the industry have emerged in response to these problems, but the government's current position is in favour of maintaining existing best practice guidance.

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• Russian Health Protection Bill Ratified

  Global Insight

  Russian President Dmitry Medvedev has signed the "On the Basis of Healthcare Provision in the Russian Federation" bill, which makes fundamental changes to the country's healthcare system and contains numerous important measures relating to the pharmaceutical industry. Some of the bill's measures related to the pharmaceutical industry have considerable uncertainty, particularly regarding provisions related to orphan drugs, those relating to the regulation of the relations between pharmaceutical representatives and healthcare professionals, and promotional activities and conflicts of interest. It is still unknown how these measures will be implemented and enforced, and what impact these changes will have. Healthcare professionals will be prohibited from receiving gifts or cash from organisations during the development and production of pharmaceuticals and medical devices, except for certain circumstances in which they are employed under contracts in clinical trials or research. Healthcare professionals also may not conclude agreements with company representatives regarding advice for patients on which medicines or medical devices should be used. In addition, the bill addresses conflicts of interest, and states that if a situation arises in which a conflict of interest exists for a healthcare professional who may have an interest in a pharmaceutical or medical device company that conflicts with his or her position, the individual is obligated to write the head of the institution at which they work to inform them of the conflict.

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