Healthcare & Life Sciences updates

Austria

Contributed by Preslmayr Attorneys at Law
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.

'Medical meets Beauty' – recent decision on dental sector advertising
  • Austria
  • 27 November 2019

The Austrian professional rules for dentists are strict and restrictive and permit advertising only within tight limits. Recent case law suggests that the Chamber of Dentists is highly active in enforcing both the Directive on Advertising and the Dental Act. Under the directive, print media ads must not exceed quarter of a page and dentists must not use unobjective advertising (eg, ads which promise patients non-dental advantages or services).

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.


Belgium

Contributed by ALTIUS
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.

Medicinal product reimbursement during pandemics and budgetary constraints: why quick fixes don't work
  • Belgium
  • 22 April 2020

The COVID-19 crisis has highlighted the fact that an EU common policy in the healthcare sector is virtually non-existent, especially in respect of medicinal product pricing and reimbursement. This article illustrates the need for national pricing authorities to consider that their policies could have unintended consequences and cross-border effects. Otherwise, national measures risk backfiring, as seems to have happened with the Belgian authorities' most recent attempt at further reducing medicinal product prices.

FAMHP adopts measures to avoid medicine shortages during COVID-19 pandemic
  • Belgium
  • 15 April 2020

The Federal Agency for Medicines and Health Products recently adopted a consolidated version of its decision to take a series of urgent measures for certain listed medicines (and raw materials) to avoid medicine shortages during the COVID-19 pandemic. The measures apply until the end of April 2020 but may be renewed on a monthly basis. This article discusses the measures and their legality under EU law in more detail.


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.


Canada

Contributed by Smart & Biggar
Amended Patented Medicines Regulations will come into force on 1 January 2021
  • Canada
  • 03 June 2020

The Patented Medicine Prices Review Board recently announced that the amended Patented Medicines Regulations will now come into force on 1 January 2021. Further, a revised set of draft guidelines will be published during the week of 15 June 2020, followed by a 30-day consultation period.

First decision under amended PMNOC Regulations: Federal Court finds Amgen's filgrastim patent obvious
  • Canada
  • 20 May 2020

The Federal Court recently issued the first decision under the amended Patented Medicines (Notice of Compliance) Regulations. In the decision, Pfizer was successful in establishing obviousness of the asserted claims of Canadian Patent 1,341,537 relating to filgrastim (Amgen's NEUPOGEN and Pfizer's biosimilar product NIVESTYM).

OCT benefits cap and private label product restrictions abolished
  • Canada
  • 01 April 2020

Most of the final amendments to regulations made under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act came into effect on or before 1 January 2020, following public consultations. One notable change compared with the proposed amendments is the removal of the financial cap on ordinary commercial term benefits. Further, private label products will no longer be prohibited from being designated as a listed drug product or interchangeable.

Federal Court of Appeal remands Remicade new use patent decision on anticipation and obviousness
  • Canada
  • 25 March 2020

In 2018 the Federal Court found that Kennedy's new use patent for infliximab (Janssen's Remicade) was valid and had been infringed by Hospira's biosimilar Inflectra. However, in January 2020 the Federal Court of Appeal released a decision remitting for reconsideration by the trial judge certain issues relating to the validity of Canadian Patent 2,261,630.

New reports on utilisation of biologics and biosimilars for chronic inflammatory diseases
  • Canada
  • 18 March 2020

The Canadian Agency for Drugs and Technologies in Health and the Ontario Drug Policy Research Network (ODPRN) have released reports examining utilisation trends of innovator biologics and biosimilar versions of infliximab and etanercept, as well as the innovator biologic adalimumab, with regard to rheumatic conditions and inflammatory bowel disease in Ontario. This article examines the takeaway messages from the ODPRN report.


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.