Healthcare & Life Sciences updates

Austria

Contributed by Preslmayr Attorneys at Law
Spiritual healing – no (illegal) quackery
  • Austria
  • June 27 2018

The delineation between medical treatment and quackery is not always easy to draw. A recent Supreme Administrative Court decision has brought some clarifications as to what constitutes legitimate medical treatment as opposed to illegal quackery.

Fat-burning injections – medical information from beauticians
  • Austria
  • April 25 2018

A client recently sued her beautician because of an unsuccessful fat-burning injection treatment. The first-instance court granted the plaintiff two-thirds of her claim, holding that the defendant had had the same obligation as a physician to provide medical information on the risks and complications. However, as the plaintiff had been aware of the defendant's inexperience, she was responsible for the contributory fault, which reduced her claim by one-third.

Medical confidentiality and right to refuse to give evidence
  • Austria
  • February 28 2018

In general, a healthcare professional may testify on observations made in respect of a patient only if he or she has been released from the obligation of confidentiality by the patient personally. However, there are a few limited exceptions to this general rule. The Supreme Court carefully applied these exemptions in a recent decision on the hypothetical release by a deceased person.

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.


Brazil

Contributed by TozziniFreire Advogados
Post-trial access: Congress discusses new bill for clinical research
  • Brazil
  • May 23 2018

The importance of clinical research for developing new treatments and discovering cures for diseases is indisputable. However, the degree to which patients benefit from participating in clinical trials and whether they should have post-trial access to experimental treatments are highly disputed, especially in Brazil, where free universal healthcare is a constitutional right. The House of Representatives is discussing clinical research and post-trial access as part of a new legislative bill.

Vaccines and points of care – growing trend
  • Brazil
  • March 28 2018

One of the most influential moves in the healthcare sector is the recent development of point-of-care solutions. The main goal is to allow patients to get on-demand healthcare outside the hospital, mainly through medical devices and apps. Such technologies are likely to have a significant positive effect in the Brazilian public health system by making diagnostic testing accessible in areas where healthcare is hard to access.

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.


Canada

Contributed by Smart & Biggar/Fetherstonhaugh
PMPRB forming working group on guideline reform
  • Canada
  • July 18 2018

The Patented Medicine Prices Review Board (PMPRB) recently announced that the next step in its guideline reform will be the inception of a multi-stakeholder working group intended to gather stakeholder input on key technical aspects of the new regime. The PMPRB anticipates concurrently releasing more specific guidance on how it foresees putting the anticipated regulatory changes into operation.

New regulations governing post-market oversight of opioids
  • Canada
  • July 18 2018

As part of a federal initiative to address the opioid crisis, the Regulations Amending the Food and Drug Regulations (Opioids) recently came into force, adding post-market oversight of prescription opioids. The minister of health can now impose terms and conditions on the market authorisation for listed opioids. The amendments also introduce a mandatory warning sticker and patient information handout for 'Class A' opioids (as set out in Part A of the List of Opioids).

Update on Vanessa's Law
  • Canada
  • July 11 2018

The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), approved in 2014, amended the Food and Drugs Act and granted new powers to the minister of health directed at post-marketing oversight of therapeutic products (ie, drugs, medical devices and drug-device combinations). There have been many developments since 2014, including the passage of certain associated regulations and the release of Health Canada guidance.

New regulations governing powers to require assessments, tests and studies
  • Canada
  • July 11 2018

The sections of the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) that grant the minister of health powers to require assessments, tests and studies and create appropriate regulations recently came into force. Among other things, the amendments support post-market safety by imposing notification requirements for foreign incidents and eliminate the requirement for filing clinical case reports in a filed submission or supplement.

Ontario Court of Appeal dismisses summary judgment appeal in Section 8 case
  • Canada
  • July 04 2018

The Ontario Court of Appeal recently dismissed Abbott and Takeda's appeal of the Ontario Superior Court of Justice's decision to dismiss their motion for summary judgment in an action brought by Apotex under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The action concerned lansoprazole, the active ingredient in Apo-Lansoprazole. The Ontario Court of Appeal concluded that the motions judge had not erred in finding that Apo-Lansoprazole would have received approval in 2007.


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.