International Life Sciences Update - April 2016



Australian Government embarks on push for growth of Biosimilars
By Jane Owen and Rebecca Currey

Approval and use of biosimilar medicines in Australia is set to grow in the wake of changes affecting registration and market uptake of biosimilar medicines. The Australian Government, recognising the growing role biosimilar medicines will play in providing treatment options to Australians in coming years, has launched an initiative aimed at improving awareness and confidence in biosimilar medicines amongst prescribers, pharmacists and patients in Australia. It has allocated $20 million to this initiative over a three year period.
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CFDA implements new review and approval system for generic drugs
By Alison Wong and Caroline Wong

The Chinese drug regulatory authority (the “CFDA”) has recently issued two policy documents to reform the review and approval system for drugs and medical devices, with the objective of improving the quality and transparency of the drug review and approval system, resolving the long standing backlog of drug registration applications, improving the quality of generic drugs and to encourage the research into and development of new drugs.
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French law will soon exclude product claims from patentability where the claimed products have been generated by an essentially biological process
By Anne-Charlotte Le Bihan and Julie Gemptel

The “Projet de loi pour la reconquête de la biodiversité, de la nature et des paysages” currently debated before French Parliament includes various measures for the protection and promotion of biodiversity, among which this important limitation brought to the scope of patentability.
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European Market Entry by public tender
By Dr. Alexander Csaki and Clarissa Junge-Gierse

The majority of contracts on pharmaceuticals, medical devices and other Life Science related products in Europe are concluded with public entities. Advice on Procurement Law brings foreign companies an advantage in successfully winning relevant market shares. The related chances and benefits are often unknown to newcomers on the European market.
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Dutch MEB held to have acted unlawfully towards patent holder by publishing the patented indication for generic medicinal products
By Armand Killan and Hanneke Later-Nijland

The Warner-Lambert Corporation, belonging to the Pfizer-group (hereinafter: "WLC") markets a medicinal product called Lyrica (active substance: pregabalin) which is prescribed for three separate indications: epilepsy, generalised anxiety disorder, and neuropathic pain. WLC is the holder of a Swiss type second medical use patent with respect to neuropathic pain.
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The limited applicability of the preferential VAT rate for the supply of spare parts for medical devices
By Justyna Sienkowska and Katarzyna Purchała

On 29 December 2015 the Polish Minister of Finance issued a general interpretation (No. PT1.050.12.2015.ALX.572), regarding the goods and services tax ("VAT") applicable to the supply of spare and replacement parts for medical devices. The aim of issuing the interpretation was to ensure uniform application of the Polish Goods and Services Tax Act ("VAT Act") by tax offices and tax inspection authorities on the one hand, and to establish whether the preferential 8% VAT rate (valid until 31 December 2016) applicable to medical devices as such could be also applied to the supply of spare and replacement parts for medical devices on the other hand.
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Re-export of drugs in the Slovak Republic
By Katarina Pfeffer & Bibiana Mozoľová

The Slovak Republic has a recurring problem with insufficiency of drug supply. Generally there are not enough vaccines for children, and cancer and heart disease medications are in short supply. Patients are very unhappy because of these shortages and are understandably upset when they are unable to purchase their medication at the pharmacy. Recently, in early January 2016, there was a shortage of heart disease medication in Handlová (located in the centre of Slovakia). 
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