Healthcare & Life Sciences updates

Austria

Contributed by Preslmayr Attorneys at Law
Alternative medical treatments and compassionate use
  • Austria
  • 25 September 2019

Patients who are beyond treatment under the standards of conventional medicine often seek help from alternative medical treatments; however, these methods pose not only medical risks for patients, but also legal risks for doctors. A recent Supreme Administrative Court decision appears to favour a liberal approach to new therapies and compassionate use and enhances the possibilities for developing new therapies and alternative medicines in future.

Maintaining original medicinal products in Reimbursement Code
  • Austria
  • 24 July 2019

When a generic is added to the Reimbursement Code, the product manufacturer or authorised distributor must reduce its price in order for the product to remain therein. If the Main Association of Social Security Institutions and the product manufacturer or authorised distributor cannot agree on a price, the product will be removed from the Reimbursement Code. A recent Supreme Court decision provides important considerations for maintaining original medicinal products in the Reimbursement Code.

Cannabidiol in food and cosmetics
  • Austria
  • 15 May 2019

While there are signs of greater liberalisation with respect to hemp use internationally, the Austrian government has resisted this trend. In October 2018 the Ministry of Labour, Social Affairs, Health and Consumer Protection published a decree outlining its legal opinion on product regulations which prohibit CBD use in food and cosmetics. However, rather than providing legal certainty, the decree merely reflects headlines relating to the government's narcotics programme.

Social security system to undergo restructure – but will it achieve cost savings?
  • Austria
  • 20 March 2019

The Austrian social security system has been characterised by regional and occupational fragmentation and the domination of employee representatives. However, a recent amendment to the Social Security Act proposes merging the provincial social security institutions with the company insurers into one Austrian Health Insurer, which will be the only provider of employee health insurance.

Amendment to Act on the Medical Profession
  • Austria
  • 23 January 2019

The two chambers of the Austrian Parliament recently adopted the government bill on the amendment of the Act on the Medical Profession. The amendment will enter into force following its publication in the Law Gazette, which is expected in late January 2019.


Belgium

Contributed by ALTIUS
Anti-tampering devices – fading boundaries of parallel trade?
  • Belgium
  • 06 February 2019

A legislative package aimed at fighting falsified medicines will enter into force in the European Union in early 2019. This EU legal framework was transposed into Belgian law through the Medicines Act and the Royal Decree concerning Medicines for Human and Veterinary Use. As a result, pharmaceutical companies will be required to affix a so-called 'anti-tampering device' on all prescription medicinal products to allow verification of whether the packaging has been tampered with.

Invalidated SPC retains prima facie validity in preliminary injunction proceedings
  • Belgium
  • 25 September 2013

A pharmaceutical company requested a preliminary injunction against a generic manufacturer based on one of its invalidated supplementary protection certificates. An appeal court granted the injunction, but the generic manufacturer appealed to the Supreme Court. The court's decision is notable for its distinction between the authority and the force of res judicata, and the implications of this distinction for rights holders.

GMO trial gets green light despite formal invalidity
  • Belgium
  • 08 May 2013

The government has implemented a strict regulatory framework for genetically modified organism field trials. But what happens when one of the players fails to respect the rules? Does it affect the valid work that has already been done by others? These questions recently arose before the Ghent Court of First Instance in the context of expedited civil proceedings initiated by Greenpeace against the Belgian state.

Mock-ups no proper notification of repackaged pharmaceutical parallel imports
  • Belgium
  • 13 February 2013

The Brussels Court of Appeal recently ruled that a parallel importer did not properly notify a pharmaceutical trademark holder when it provided a two-dimensional mock-up of the outer packaging, rather than an actual sample, of the repackaged pharmaceutical as it would be presented on sale. The decision provided much-needed clarity, as the first instance court had issued contradicting decisions on the matter.

Doctors not easily misled? Brussels court decides on pharmaceutical advertising
  • Belgium
  • 28 November 2012

The Brussels Commercial Court has dismissed Pfizer's misleading claims directed against an advertisement for a generic product marketed by Eurogenerics, as well as Eurogenerics's counterclaim regarding the marketing of Pfizer's own generic product. The court's relaxed views on doctors' awareness of the regulations on reimbursement and their implications will be of interest to pharmaceutical marketeers.


Brazil

Health sector transparency laws
  • Brazil
  • 05 September 2018

Since 2016 Minas Gerais has been establishing transparency laws to create a system whereby consumers and society at large will be able to access information regarding incentives and payments between healthcare professionals and the health industry. Under the state laws, the health industry must provide information on the relationships that they maintain with healthcare professionals which may represent a potential conflict of interest.

Post-trial access: Congress discusses new bill for clinical research
  • Brazil
  • 23 May 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
  • 28 March 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
  • 08 November 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.


Canada

Contributed by Smart & Biggar
Countdown begins: getting ready for new patented medicines pricing regime
  • Canada
  • 18 September 2019

The long-awaited amendments to the Patented Medicines Regulations were recently published in Part II of the Canada Gazette. Major changes include the introduction of three new price regulatory factors and a revised schedule of reference countries. Although the new law will not be in force until 1 July 2020, there are immediate implications.

Market access: biosimilars no longer reviewed by CADTH
  • Canada
  • 18 September 2019

The Canadian Agency for Drugs and Technologies in Health (CADTH) recently released Issue 8 of its Pharmaceutical Reviews Update announcing revisions to its Procedure and Submission Guidelines for the CADTH Common Drug Review, among other things. The update also announced that the CADTH will no longer review biosimilars through the Common Drug Review or the pan-Canadian Oncology Drug Review.

Updates to guidance documents: what you need to know
  • Canada
  • 11 September 2019

Health Canada recently released a revised Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs, which is effective immediately. The revisions include clarifying additions on the requirements for cross-licensed products for an administrative certification form and letter of authorisation, a drug notification form and labelling. Health Canada also recently released an updated Good Label and Package Practices Guide for Prescription Drugs.

Canada releases final amendments to patented medicines pricing regulations
  • Canada
  • 11 September 2019

Health Canada recently announced the final amendments to the Patented Medicines Regulations. The amendments – which represent the first substantive revision to the regulations since their introduction in 1987 – are a significant departure from the existing framework and include new price regulatory factors, updated reference countries and changes in reporting requirements.

Health Canada consults on promotional and non-promotional activities for health products
  • Canada
  • 04 September 2019

Health Canada has announced a consultation on its new draft guidance: The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products. The guidance is intended to clarify and outline the factors and circumstances that contribute to rendering a message or activity non-promotional.


Cyprus

General Healthcare System contributions
  • Cyprus
  • 10 April 2019

As of 1 March 2019, employees, pensioners, state officials and income earners in Cyprus must contribute 1.7% of their income to the General Health System, while self-employed individuals must contribute 2.55% of their income. Private employers must also make General Health System contributions of 1.85% on emoluments made to employees, while the state must make an additional contribution of 1.65% of the incomes of employees, self-employed individuals, pensioners and government officials.