Healthcare & Life Sciences updates

Africa

Contributed by ENSafrica
Current pharmaceutical invention patent restrictions
  • Africa
  • 09 December 2020

A number of African World Trade Organisation members have supported a proposal to waive certain provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement for the prevention, containment and treatment of COVID-19. It appears that this is an opportune time for many least-developed countries (LDCs) to extend the TRIPS exemptions beyond the COVID-19 pandemic to address the many challenges which they face, especially regarding neglected tropical diseases.

African Union publishes COVID-19 vaccine strategy
  • Africa
  • 05 August 2020

The African Union (AU) recently published a COVID-19 vaccine strategy. The strategy was announced in a communique issued by the AU ministers of health and heads of delegation following a virtual conference on 24 and 25 June 2020. Access to medicine in Africa is a recurring concern and it may be an opportune moment to use the response to the COVID-19 pandemic as a blueprint to secure future access to pharmaceuticals – including vaccines – for Africans.


Austria

Contributed by Preslmayr Attorneys at Law
Ascertainment of (dis)conformity of in vitro diagnostics
  • Austria
  • 10 March 2021

The Supreme Court of Justice recently found that a party involved in the marketing of in vitro diagnostics devices did not infringe the Act on Medical Devices or EU Directive 98/79/EC because the devices in question bore the CE mark. The decision clarifies that only the Federal Office for Safety in Healthcare is competent to ascertain whether a CE mark is correctly affixed.

Medical information duty: what constitutes reasonable steps to contact a patient?
  • Austria
  • 03 February 2021

The medical information duty comprises the obligation to inform a patient of possible dangers and negative consequences of a treatment or failure to have such treatment. This information duty exists not only if the patient's consent to a medical treatment is required, but also if the patient must make an informed decision to refrain from having further medical treatment. However, as demonstrated in a recent Supreme Court case, patients must allow their doctor to provide such information.

Restriction of freedom in nursing homes due to risk of COVID-19 infection
  • Austria
  • 06 January 2021

The Supreme Court recently ruled that nursing homes can restrict residents' freedom by isolating them in their room. The resident in question had been isolated in his room in an attempt to prevent the spread of COVID-19 among the other nursing home residents. This decision shows the interaction between protecting the freedom of nursing home residents and challenges caused by the COVID-19 pandemic.

Reimbursement for medicine not listed in Reimbursement Code?
  • Austria
  • 21 October 2020

Although Austrian social security provides for a legal entitlement to benefits in kind (ie, free administration of medicines listed in the Reimbursement Code, except for a small prescription fee), the Organisation of Austrian Social Security is reluctant to reimburse the cost of medicines not listed in the Reimbursement Code. A recent Supreme Court decision shows that this restrictive approach is supported by the Austrian courts.

Constitutional Court overrules COVID-19 restrictions
  • Austria
  • 02 September 2020

In March 2020 the legislature enacted the COVID-19 Measures Act, which authorised the Federal Ministry for Social Affairs, Health, Care and Consumer Protection to enact regulations prohibiting access to business premises to the extent necessary to prevent the spread of COVID-19. Based on this provision, the ministry enacted the COVID-19 Measures Regulation; however, the Constitutional Court recently overruled Sections 1, 2, 4 and 6 of the regulation.


Belgium

Contributed by ALTIUS
Must AstraZeneca supply the European Union with sufficient COVID-19 vaccines under Belgian law?
  • Belgium
  • 10 February 2021

AstraZeneca recently announced that it would reduce the supply of its COVID-19 vaccine to the European Union in the first quarter of 2021 to 31 million doses. Questions have therefore arisen as to what extent AstraZeneca is under a contractual obligation to supply the European Union with the initially planned 80 million doses, and what role its UK manufacturing sites should play in this regard. To answer these questions, this article examines the parties' rights and obligations under Belgian law.

BCA suspects Caudalie of imposing minimum resale prices on distributors and limiting active and passive online sales
  • Belgium
  • 20 January 2021

Following dawn raids carried out in 2018, the Belgian Competition Authority's Investigation and Prosecution Service has opened an investigation regarding alleged anti-competitive practices committed by Caudalie, a French cosmetics company specialising in vinotherapy, after a Belgian pharmacist complained that his supplier was imposing a pricing policy on him.

Which COVID-19 vaccines are on the menu for Belgium?
  • Belgium
  • 23 December 2020

Belgium is following the lead of the European Commission and the European Medicines Agency with respect to its COVID-19 vaccine strategy. The European Commission, on behalf of EU member states, has already concluded six advance purchase agreements with vaccine suppliers for a potential total of almost 2 billion doses. Belgium's share presently amounts to a total of 22.4 million vaccines. Purchasing is expected to begin in early January 2021.

Can parallel importers rebrand generic medicines?
  • Belgium
  • 04 November 2020

If a branded medicine and its generic version are put on the EEA market by economically linked undertakings, is a parallel importer then allowed to rebrand and repackage the imported generic version as the branded reference medicine? This issue recently led the Brussels Court of Appeal to refer three questions to the European Court of Justice (ECJ). In anticipation of the ECJ's ruling, this article provides the factual background and explains why a parallel importer should not be allowed to rebrand in such cases.

BCA confirms that merger control rules apply to creation of loco-regional hospital networks
  • Belgium
  • 12 August 2020

The Belgian Competition Authority's (BCA's) latest note reiterates that competition law rules concerning merger control fully apply to the creation of local hospital networks as required under the Act of 28 February 2019. Although hospitals seem largely unaware of the obligations under the merger control rules attached to such forms of cooperation, they should consider that the BCA is paying more attention to the sector and that significant penalties may be incurred for non-compliance.


Canada

Contributed by Smart & Biggar
Patentability of diagnostic methods – has the Patent Office drawn the line?
  • Canada
  • 07 April 2021

IP offices have long grappled with whether a medical diagnostic constitutes a traditionally patentable concrete or physical method or instead is merely an unpatentable and intangible abstract idea. Although a new diagnostic tool is typically embodied in a physical device or method, the principal advance often lies in the recognition of a previously unknown correlation. New guidance from the Patent Office is a welcome step forward in this difficult area.

Federal Court finds silodosin formulation patent valid but not infringed
  • Canada
  • 24 February 2021

The Federal Court recently issued a decision in a patent infringement action pursuant to Section 6(1) of the Patented Medicines (Notice of Compliance) Regulations relating to silodosin. Although the court found that the patent was not invalid on the basis of obviousness, it also found that the patent had not been infringed.

Innovators challenge final PMPRB Guidelines in new Federal Court application
  • Canada
  • 09 December 2020

Innovative Medicines Canada and numerous research-based pharmaceutical companies recently commenced an application for judicial review of the final Patented Medicine Prices Review Board Guidelines. The guidelines aim to operationalise amendments to the Patented Medicines Regulations scheduled to come into force on 1 January 2021.

Few significant changes made in final PMPRB guidelines
  • Canada
  • 25 November 2020

The Patented Medicine Prices Review Board recently published the final version of its guidelines which operationalise the amendments to the Patented Medicines Regulations scheduled to come into force on 1 January 2021. This article provides a brief summary of the final framework for the price review process and highlights changes relative to the June 2020 draft guidelines.

Federal Court orders minister of health to issue NOC to Fresenius Kabi for biosimilar
  • Canada
  • 25 November 2020

Justice Manson of the Federal Court recently ordered the minister of health to issue a notice of compliance to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie's HUMIRA. The minister of health had completed its review of Fresenius Kabi's new drug submission for IDACIO; the only outstanding issue was whether Fresenius Kabi had addressed the patents listed on the Patent Register in respect of HUMIRA.


Cayman Islands

Contributed by Ogier
Advance healthcare directives
  • Cayman Islands
  • 10 March 2021

In 2019 the Health Care Decisions Act was implemented in the Cayman Islands. This law allows individuals to determine their wishes surrounding medical care and treatment, including end-of-life care, should they become mentally incompetent, and prepare a legal document to this effect. The legal document (known as an 'advance healthcare directive') outlines preferred medical treatments and procedures, such as life support and resuscitation.