International Life Sciences and Healthcare Update
EU
UK
Germany
Italy
Poland
Slovakia
China
Australia
EU
Pharmaceutical companies outsourcing clinical trials to group companies may pay substantially more taxes
A patent or innovation box is a type of tax incentive in the form of an exemption, deduction or reduced corporate income tax rate for certain income arising from the exploitation of IP. In most countries, the IP was limited to patents (hence, the “patent box”), but some countries also accepted a much broader range of IP protection (e.g. trademarks, plant variety rights, models and designs, …). Although patent boxes are general in nature and mandatorily applicable to all sorts of businesses and sectors, the rules have been very much driven (and often written) by the pharmaceutical industry...
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Medical Devices and In Vitro Diagnostic Medical Devices Reform
After several years of discussion and public consultations, the European Commission has published its proposal for two regulations (which, after publication, will be immediately binding on all EU Member States without transposition into national law) intended to replace the existing directives: one on medical devices, MDs (the “MDR"), and the other on in vitro diagnostic medical devices, IVDs (the "IVDR")...
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Recent changes to the Orphan Drug guidelines
The EU’s regulatory framework for orphan drugs is set out in Regulation (EC) No.141/2000 (the “Orphan Drug Regulation”, or ODR) and implementing Regulation (EC) No. 847/2000, and has been in force for a while now with relatively few changes. However, in recent years, a number of issues which challenge the current system have emerged, and the European Commission has attempted to address some of these by amending its (non-legally binding) guidance.
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UK
Accelerated Access Review report published
In October 2016, the final report on the Accelerated Access Review (AAR) of innovative medicines and medical technologies was published, putting forward a series of recommendations on how to speed up access to innovative drugs, devices, diagnostics and digital products to National Health Service (NHS) patients. The report was independently chaired, and has been generally welcomed by industry...
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Germany
Pregabalin and others – second medical use patents and public health insurance companies in Germany
Second Medical Use patented drugs will become increasingly prevalent in the near future. The Pregabalin case provides that those active substances hold the potential for extensive legal conflicts in the field of patent law as soon as generic companies enter the market.
Still, public healthcare providers in most European countries have a high degree of interest in concluding agreements with generic companies in order to take advantage of their favourable prices. Also, in Germany, public sickness funds attempted to conclude rebate contracts for generic Pregabalin. As a result, Pregabalin became subject to procurement law.
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German Federal Patent Court grants compulsory licence for HIV-Medicament
Following an oral hearing held on 30 and 31 August 2016 the German Federal Patent Court (‘Bundespatentgericht’) has decided in preliminary injunction proceedings to grant Merck a compulsory licence for the distribution of its HIV medicament, “Isentress”. This was the first time in the 55-year history of the Federal Patent Court that a compulsory licence has been granted in PI proceedings. The only other example of a compulsory licence being granted was during the course of main proceedings and the decision was later overturned on appeal by the Federal Supreme Court (‘Bundesgerichtshof’) (cf. BGH GRUR 1996, 190 – Polyferon)...
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ECJ rules against fixed prices for prescription medicaments in Germany
On 19 October 2016 the Court of Justice of the European Union handed down a judgment wherein it found that the current German fixed price regime for prescription drugs is in violation of the EU principle of free movement of goods (docket no.:. C-148/15).
The case was brought by the Association for Protection against Unfair Competition (Zentrale zur Bekämpfung unlauteren Wettbewerbs eV'; ZBW) against the German Parkinson Association (‘Deutsche Parkinson Vereinigung'; DPV) before the Regional Court of Düsseldorf...
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Italy
No trade mark exhaustion in parallel imports if separate trade mark owners are involved
By an order dated 17 October 2016, the Court of Milan confirmed that a trade mark proprietor can enforce its right to oppose the sale of parallel imported goods which were put on the market in the country of export by a different trade mark proprietor.
In summary, the Court established – following CJEU case law – that there is no exhaustion of trade mark rights where there are separate trade mark owners who are not linked legally (for example through a licence agreement) or economically (for example thorough a corporate structure)...
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Poland
Radical Changes to Reimbursement Policy in Poland
The Polish reimbursement system will undergo significant reorganisation in 2017. Currently, two bills amending the Polish Act on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices appear to have important consequences for the pharmaceutical sector. These are: (i) the amendment bill of 21 September 2016, the so-called "major amendment"; and (ii) the amendment bill of 10 June 2016, designed to completely overhaul the reimbursement of medical devices, the so-called "medical devices amendment".
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Slovakia
E-health in Slovakia: Background, Current Status, Vision and Challenges
In 2008, after receiving government approval, the Slovak Ministry of Health began its preparations for, and the strategic development of, the National portal of electronic health ("eHealth"). eHealth will be operating under the National Health Information Center ("NCZI"), while the legal framework is set forth in Act 153/2013 Coll. on the National Health Information System, as later amended. The purpose of this Act is to increase the efficiency and quality of healthcare through informatisation (i.e. through the application and role of information technology). Although the Act has only been in force since 1 July 2013, it has already been amended several times. The changes relate to the fact that full implementation of eHealth in Slovakia has been repeatedly postponed for several reasons, including a lack of preparation by the State and associated stakeholders for its full operation...
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Re-export of drugs in the Slovak Republic vol. 2 – the Act
We have commented previously on the troubling situation as regards insufficient drug supply in the Slovak Republic due (primarily) to the re-export of drugs. In our earlier article, we reported that the aim of the Ministry of Health in Slovakia (Ministerstvo zdravotníctva Slovenskej republiky) was to avoid this situation through implementing a change in the current legislation. As described in that article, re-export mainly refers to drugs that are profitable for export. They are usually non-generic, relatively expensive drugs, such as cancer medication, vaccines, immunological medicinal products and osteoporosis medication sometimes used in rheumatology. In many cases the drugs are necessary for the treatment of serious and high-risk diseases which cannot otherwise be treated.
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China
China Announces Full Scope Standards on Food Packaging Materials and Articles
On 18 November 2016, the National Health and Family Commission (NHFPC) announced the implementation of 53 food-related standards1, including the long awaited Standard on General Safety Requirements for Food-contact Materials and Articles (GB 4805.1-2016), the Standard on the Use of Additives in Food-contact Materials and Articles (GP9685-2016), in addition to material and testing standards for a broad spectrum of materials and substances.
Australia
Federal Court rules that overseas manufacture will not avoid infringement of Australian Swiss Claims
A recent decision in the Federal Court of Australia has confirmed that the importation and sale of a medicament manufactured overseas will constitute infringement of the Swiss claims of an Australian Patent: Apotex Pty Ltd v Warner-Lambert Company LLC (No 2) [2016] FCA 1238 (Pregabalin).
The patent in suit in Pregabalin contained numerous Swiss claims directed to the use of a compound (including the compound known as Pregabalin) in the manufacture of a medicament for the treatment of pain. Whilst method of treatment claims are patentable subject matter under Australian law, it is also common practice for patentees to include Swiss claims as well.
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