International Life Sciences Update - July 2015


Inventive Step: How high is the obviousness threshold?
As part of the long running legal battle in Australia concerning the validity (and infringement) of a series of second generation patents in respect of the cholesterol lowering drug rosuvastatin (Crestor®), the High Court of Australia is set to refine the threshold of the inventive step required in Australia for a patentable invention.
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China issues a further 90 industry standards for medical devices
Demand for medical devices is increasing in China, especially in the wealthier urban areas. With an estimated value of over $17-billion the Chinese medical device market is the world's fourth largest with many opportunities for overseas companies. In an effort to ensure the continued safety and effectiveness of devices, there have been many recent changes and revisions to the Chinese regulatory framework for certification by the China Food and Drug Administration (CFDA).
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China releases draft stem cell clinical trial regulation
To date China has had one of the most unrestrictive embryonic stem cell research policies in the world.  According to the U.S. National Institutes of Health there were 164 stem cell clinical trials taking place in China during 2014, second only in number to the U.S. and Europe. In order to improve the regulatory pathway for stem cell trials, in March 2015 the China Food and Drug Administration (CFDA) released a draft guidance document, the Management Measures on Clinical Trial of Stem Cells, for public consultation and comment.
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China amends the Drug Administration Law and removes price caps for most pharmaceutical products
In a widely expected announcement, China's National Development and Reform Commission (NDRC) has stated that from 01 June 2015 the government- imposed price caps on the vast majority of medicines will be removed except for narcotic anaesthetic products and class-1 psychoactive drugs. The NDRC's announcement follows the recent 7th amendment to the Drug Administration Law and the removal of Article 55, which stated that pharmaceutical companies, distributors and medical institutions were required to adhere to the government's pricing mechanism.
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Recent Evolutions of the “French Sunshine Act”
Following the "Mediator" scandal, France decided to implement new rules on the transparency between the pharma industry and Health Care Professionals ("HCPs") inspired by the US Physician Payments Sunshine Act. The Loi Bertrand (n° 2011-2012) was adopted on 29 December 2011 and has been complemented by Decree n° 2013-414 of 21 May 2013.

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Remedies to combat parallel export of medicines – a novelty of Polish pharmaceutical law
The inclusion of a wide range of important medicines on the reimbursement list and the related drop in their prices has led to the uncontrolled export of medicines outside Poland. Wholesalers tempted by this attractive market situation have been selling these medicines on more lucrative markets, not taking into account the shortage of important medicines in Polish pharmacies which may threaten public health.
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The new "Managed Entry Agreements" (MEAs) 
Recession and consequent cuts in public pharmaceutical expenditure in Europe have slowed down the access to market of pharmaceutical innovations in the last few years. As a solution, public health authorities and pharmaceutical companies have searched for alternative funding formulas, in order to share the risks and uncertainties arising from public coverage of new medicinal products, whose clinical effectiveness and budgetary impact are still unknown. 
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Medical device liability update
On 5 March 2015, the Court of Justice of the European Union ("CJEU") delivered its ruling on product liability in joined cases C-503/13 and C-504/13 Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt – Die Gesundheitskasse, Betriebskrankenkasse RWE ("Boston Scientific") following a reference from the Bundesgerichtshof (German Federal Court).  The ruling affects the liability of manufacturers of high risk products (such as active implantable medical devices) under the Product Liability Directive ("PLD")[1], but may also have consequences for their insurers and Notified Bodies.   
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