Healthcare & Life Sciences updates

Africa

Contributed by ENSafrica
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
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.

Relevance of expert guidelines for assessing medical malpractice
  • Austria
  • 01 July 2020

Recent case law suggests that, although medical society and other expert committee guidelines are non-binding, they may serve as evidence to specify current medical standards. However, as they cannot be considered on the same level as medical standards, the application of such guidelines to specific cases requires an expert assessment.

Leucopenia medicine and reimbursement code
  • Austria
  • 11 March 2020

A landmark Supreme Administrative Court decision concerning Onpro Kit, a medicine for treating chemotherapy-induced leucopenia, provides further clarity on the inclusion of medicines in the Main Association of Austrian Social Security Institutions' reimbursement code. The court examined the special circumstances in which a medicine is inappropriate for use in the course of medical treatment because it is designated for use predominantly in hospital treatments.

Digital health: proposal to amend Health Telematics Act
  • Austria
  • 19 February 2020

The Ministry of Health recently provided Parliament with a draft amendment to the Health Telematics Act for public consultation. The proposal aims to remedy a number of challenges relating to Austria's existing immunisation system through the introduction of electronic immunisation cards and a central register of vaccinations.


Belgium

Contributed by ALTIUS
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.

Parliament adopts act increasing transparency of managed entry agreements
  • Belgium
  • 06 May 2020

Parliament recently adopted a new act to increase the transparency of managed entry agreements (MEAs) concluded between pharmaceutical companies and the National Institute for Health and Disability Insurance. MEAs stipulate confidential compensation mechanisms for the government regarding the publicly listed price and reimbursement basis of the medicines concerned.

Federal government restricts sale of PPE and medical devices for fighting COVID-19
  • Belgium
  • 29 April 2020

The minister of economic affairs recently adopted a ministerial decree which restricts the retail and wholesale distribution of certain types of personal protective equipment and medical devices used for treating COVID-19 patients. Further amendments were implemented by ministerial decrees on 27 March 2020 and 7 April 2020. This article provides a short description of the relevant trade restrictions followed by a legal analysis in light of fundamental principles of EU law.

Medical supplies: public procurement procedures in cases of extreme urgency
  • Belgium
  • 29 April 2020

The COVID-19 outbreak has created an urgent need for certain goods, including medicines and medical devices. However, do public authorities (eg, hospitals) still need to follow the complete public procurement procedures to procure these urgently needed goods? In cases of extreme urgency, such as that presented by the COVID-19 pandemic, contracting authorities can use the negotiated procedure without publication to place tenders.


Canada

Contributed by Smart & Biggar
Health Canada issues interim order respecting drug shortages relating to COVID-19
  • Canada
  • 11 November 2020

The minister of health recently approved the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19, which introduces new tools to address drug shortages, or the risk of drug shortages, that may be caused or exacerbated by the COVID-19 pandemic. This article examines some of the interim order's main features.

CADTH harmonises drug reimbursement review process
  • Canada
  • 11 November 2020

The Canadian Agency for Drugs and Technologies in Health (CADTH) recently announced the launch of new Procedures for CADTH Drug Reimbursement Reviews, which harmonise procedures under the CADTH's drug reimbursement review pathways. This article outlines the procedure's main highlights.

New interim order for COVID-19 drugs has wide-reaching impact
  • Canada
  • 04 November 2020

The minister of health recently approved the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. Once approved by the governor in council, the interim order will be valid for only one year from the day on which it was signed by the minister, and product authorisations issued under the interim order will be valid only while the interim order is in effect.

Final PMPRB guidelines released
  • Canada
  • 04 November 2020

The Patented Medicine Prices Review Board (PMPRB) recently released the final guidelines operationalising the amended Patented Medicines Regulations. The guidelines describe the price review methodology that will apply to medicines from 1 January 2021, when the amended regulations come into force. The PMPRB has also released its October 2020 Newsletter, which includes an overview of final changes as well as next steps, outreach and engagement opportunities.

8 important life sciences IP issues for innovators doing business in Canada
  • Canada
  • 30 September 2020

The US-Canada border is the longest border between any two countries and US goods and services trade with Canada totalled an estimated US$718.5 billion in 2018, possibly the largest bilateral trade volume between two individual countries. Given the extensive integration of the Canadian and US economies, US life sciences companies can expect to have Canadian business interests. This article highlights eight life sciences IP issues of importance for innovators doing business in Canada.


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.