Healthcare & Life Sciences updates

Austria

Contributed by Preslmayr Attorneys at Law
Medical information and informed consent
  • Austria
  • January 03 2018

Providing patients with insufficient medical information may impede their ability to give informed consent to proposed medical treatments and thus may trigger the tort liability of physicians or healthcare institutions. However, a March 2017 Supreme Court decision has reduced the scope of the medical information that must be provided to patients.

Assessing demand for public pharmacies – a never-ending story
  • Austria
  • October 04 2017

Public pharmacies are heavily regulated in Austria. The opening of new (or the relocation of existing) pharmacies is subject to approval by the district authority. Approval will be granted only if there exists a viable need for the new public pharmacy. In a recent case, two courts ignored a 2016 amendment to Section 10 of the Pharmacies Act, which allowed a deviation from the strict 5,500 person limit set out therein.

New price cap for medicinal products
  • Austria
  • July 19 2017

After 14 months of negotiations between the Federation of Austrian Social Security Institutions and the pharmaceutical industry, and lengthy discussions within the government coalition, Parliament recently adopted a new price cap for expensive medicinal products and a new price regime for generics and biosimilars. The government, social security institutions and the legislature hope that these amendments will create further savings in relation to expenses for medicinal products.

Nepafenac – no SPC for composition medicines
  • Austria
  • April 12 2017

The Vienna Higher Regional Court recently provided valuable conclusions about the interpretation of Article 3(a) of the Supplementary Protection Certificate Regulation – specifically, whether a functional identification of an active ingredient in a basic patent is sufficient to assess whether a product can be considered as "protected by a basic patent in force".

Medicinal products by presentation
  • Austria
  • January 25 2017

The Supreme Court recently ruled on the line between dietetic foods and medicinal products by presentation. The defendant was ultimately ordered to cease and desist from distributing its product OMNi-BiOTiC MIGRAene as a medicinal product without marketing authorisation and using the product's name. This decision is important as it keeps a close watch on the thin line between dietetic foods and medicinal products.


Brazil

Contributed by TozziniFreire Advogados
Creating healthcare solutions with blockchain technology
  • Brazil
  • November 08 2017

The continuity of traditional healthcare models seems unlikely with the breakthrough of disruptive technologies. Historically, the healthcare sector has been slow to implement technological tools that have quickly transformed other areas of people's daily lives. However, a promising solution to address the interoperability, integrity and security challenges presented in the healthcare sector seems to be blockchain technology.

Telemedicine and its effects on healthcare
  • Brazil
  • September 06 2017

Advances in technology and the so-called 'fourth industrial revolution' continue to have an effect on society. For instance, telemedicine has rapidly developed and transformed the services provided by healthcare providers worldwide. Due to the expansion of telemedicine in Brazil, the Federal Council of Medicine intends to review and update Resolution 1643, which will hopefully attract new players to the market.

Tax aspects of healthcare products
  • Brazil
  • July 26 2017

Brazil's complex and inefficient tax system is known worldwide. In addition to a heavy tax burden, the tax compliance costs that companies must bear in order to do business in the country are particularly high. This is also the case for the healthcare sector. However, there are specific cases of tax exemption, 0% tax rates and other exceptions which aim to reduce the final price of pharmaceutical products, devices and equipment. Several of these rules add to the complexity of Brazil's puzzling tax system.

HIV self-testing kit now available
  • Brazil
  • June 28 2017

Brazilian citizens will soon be able to test themselves for the HIV virus in their blood. The National Health Surveillance Agency recently approved the registration of the first HIV self-testing kit in the country, following the issuance of Resolution 52/2015. Brazil has joined other countries which have already approved the registration of an HIV self-testing kit to help to fight against undiagnosed people living with HIV.

Health insurers now face less bureaucracy when negotiating their assets
  • Brazil
  • May 24 2017

The National Supplementary Health Agency recently issued a new normative instruction regulating the free flow of securities and allowing health insurers to request an annual prior authorisation in order to negotiate and use their assets as financial guarantees to obtain additional revenue. This measure is vital for the health insurance sector, as the use of financial guarantees for assets may play an important role in companies' fight against the existing political and economic situation in Brazil.


Canada

Contributed by Smart & Biggar/Fetherstonhaugh
PMPRB releases scoping paper concerning proposed amended regulations
  • Canada
  • January 17 2018

The Patented Medicine Prices Review Board recently released a high-level overview of the potential new framework proposed by the Regulations Amending the Patented Medicines Regulations. The overview aims to provide a non-binding outline of preliminary thoughts on how best to implement the proposed changes and should be read in conjunction with the proposed amendments and the regulatory impact analysis statement.

Decision striking out challenge to constitutionality of PMPRB regime upheld
  • Canada
  • January 17 2018

The Federal Court of Appeal recently upheld the decision striking out Alexion's pleadings challenging the constitutionality of the Patented Medicine Prices Review Board (PMPRB) regime. The Federal Court of Appeal upheld the decision on the basis of, among other things, the fact that Alexion had not been entitled to bring the constitutional issue before the Federal Court, as it had not raised the issue before the PMPRB.

Canada releases proposed amendments to patented medicines pricing regulations
  • Canada
  • January 10 2018

The governor in council recently published the proposed Regulations Amending the Patented Medicines Regulations. The proposed regulations represent a significant overhaul of the Patented Medicines Regulations and are estimated by Health Canada to result in savings of C$12.6 billion net present value over 10 years. While the regulations have yet to be adopted, companies should be factoring these potential changes into their business planning now.

Health Canada publishes final guidance documents on quality requirements for regulatory filings
  • Canada
  • January 03 2018

Health Canada recently published the final version of a number of guidance documents and templates which implement new requirements for new drug submissions and abbreviated new drug submissions. The changes will be implemented by way of a phased-in approach, with the general quality guidance requirements being implemented in January 2018 and the new stability requirements and requirements for commercial and pilot scale batches being implemented in October 2019.

PMPRB releases Annual Report 2016
  • Canada
  • December 20 2017

The federal minister of health recently submitted the Patented Medicine Prices Review Board Annual Report 2016 to the House of Commons and the Senate. The report indicates that in 2016 Canadian patented drug prices were the fourth-highest among the seven comparator countries against which the board reviewed prices and that sales of patented drug products totalled C$15.5 billion. Research and development spending remained unchanged from 2015.


China

Regulation on the Supervision and Administration of Medical Devices amended
  • China
  • June 28 2017

The State Council recently promulgated amendments to the Regulation on the Supervision and Administration of Medical Devices 2014, which took effect immediately. The amendments clarify issues relating to device distributors' liabilities when selling non-conforming products, the use of large medical equipment and the revocation of clinical study site certification.

CFDA calls for comments on key policy proposals
  • China
  • May 31 2017

The China Food and Drug Administration recently issued four new draft policies for public comment, proposing further reforms to the existing drug and medical device regulatory regime. The draft policies aim to expedite the review and approval of new drug and medical device applications, deregulate the conduct of clinical trials to encourage innovation, enhance post-market supervision throughout a product's lifecycle and protect innovators' rights.

CFDA amends medical device recall rules
  • China
  • March 22 2017

The China Food and Drug Administration recently issued the Provisions for Medical Device Recall. While the new recall rules follow the basic regulatory framework for recalling devices provided in the existing rules, they also introduce some significant changes. The new rules clarify the scope of their application and the entity responsible for recalls, expand the definition of a 'defective product' and increase the penalties for manufacturers that refuse to implement mandatory recalls.

State Council announces policies to reform pharmaceutical industry
  • China
  • March 08 2017

China's pharmaceutical industry is set to undergo further change as part of the healthcare reform initiatives recently announced by the State Council in its Circular on Several Opinions Concerning Further Reforms of the Policies Governing Drug Production, Circulation and Usage. The circular reinforces the government's determination to expedite the approval process for new drugs and calls for quality consistency tests for generics.

CFDA solicits comments on pharmaceutical GCPs
  • China
  • January 18 2017

The China Food and Drug Administration recently proposed the most comprehensive revisions of the pharmaceutical good clinical practices (GCPs) in 13 years. The revisions have rewritten the articles of the existing pharmaceutical GCPs and provide general principles for conducting clinical studies in China; guidance on the roles and responsibilities of ethics committees, investigators and sponsors; and requirements for protocol and investigator brochures.


Denmark

Court awards historically high damages in patent case
  • Denmark
  • February 08 2017

The Maritime and Commercial High Court recently awarded Teva Denmark A/S €13.45 million in damages and €594,000 in legal costs in a patent case. This is the largest amount of damages ever awarded in a Danish patent case and will therefore be subject to thorough review when constructing arguments on damages in future cases.

Repackaging parallel imported pharmaceuticals – new interpretation of necessity requirement
  • Denmark
  • December 14 2016

The Maritime and Commercial High Court recently referred to the European Court of Justice the question of whether a trademark holder can lawfully object to the continued marketing of a parallel imported, repackaged pharmaceutical product on which its trademark has been reaffixed if the trademark holder has marketed the product in the same volume and packet size in other European Economic Area countries.

Quetiapine patent invalidated – Danish court follows suit
  • Denmark
  • September 07 2016

The Maritime and Commercial High Court recently invalidated AstraZeneca's Danish quetiapine sustained release patent in litigation against Teva Denmark A/S and Accord Healthcare Ltd. Before this judgment, the validity of AstraZeneca's patent had been successfully challenged in several European countries, including the United Kingdom, Spain, Germany and the Netherlands.

Specific Mechanism applies to paediatric extension of SPCs and all strengths of pharmaceutical
  • Denmark
  • June 08 2016

The Supreme Court recently examined a case regarding whether the Specific Mechanism applies to the extension of a supplementary protection certificate (SPC) under the Paediatric Extension Regulation. The court confirmed the enforceability of the Specific Mechanism against the parallel import of pharmaceuticals from new EU member states, even if the extended SPC is based on the Paediatric Extension Regulation.

No particular importance attached to European invalidity judgments regarding European patent
  • Denmark
  • March 30 2016

The question of whether courts should consider foreign invalidity judgments regarding the same European patent is a common theme in patent proceedings. According to a recent decision in a case concerning a request for a preliminary injunction against the sale of a generic version of pharmaceutical Seroquel Prolong on the Danish market, little importance is attached to foreign invalidity judgments.