Latest updates

Outpatient medical care facility infrastructure and equipment in times of technological advances
Sanchez DeVanny Eseverri SC
  • Mexico
  • 29 July 2020

During the COVID-19 pandemic, new technologies such as telemedicine and remote medical services have become even more relevant due to the risks associated with close physical contact in hospitals and other places where COVID-19 sufferers may be present. A new Official Mexican Standard, which was recently published in the Federal Official Gazette, sets out the minimum requirements applicable to infrastructure and equipment required for outpatient medical care facilities.

Life sciences patent bargain front and centre in Regeneron v Kymab
Pinsent Masons
  • United Kingdom
  • 22 July 2020

The recent Supreme Court decision in Regeneron v Kymab has highlighted the risk-reward dynamic that exists for pharmaceutical and biotechnology companies that seek patent protection for innovations early in the discovery process. The court found that if a claimed patent monopoly defines a whole range of products, all of the products within the 'relevant range' must be appropriately enabled by the patent specification. This decision is of great importance to the biotechnology and wider life sciences sector.

Q&A on ABS compliance in South Africa
ENSafrica
  • South Africa
  • 22 July 2020

There has been much debate in recent years as to the effectiveness of access and benefit sharing provisions relating to indigenous biological and genetic resources (IBGRs) and traditional knowledge or indigenous knowledge (IK) as set out in the Convention on Biological Diversity and adapted into local legislation of member countries. This article explores the situation in South Africa, one of the most megadiverse countries in the world with a wealth of IK relating to IBGRs.

Relevance of expert guidelines for assessing medical malpractice
Preslmayr Attorneys at Law
  • 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.

Life sciences acquisitions and divestments
ENSafrica
  • South Africa
  • 01 July 2020

To establish a portfolio of investments, BioVentures, South Africa's first niche biotechnology and life sciences venture capital fund, looked for South African start-ups with proprietary technology that gives them a competitive advantage; a large, growing and preferably international market; multiple products and markets rather than a single product and market; and a quality and balanced management team. This article considers these points in more detail to create a checklist for divestiture preparation or asset hunting.

Compulsory licensing under Infection Protection Act: effects on data exclusivity under pharmaceutical law
Simmons & Simmons LLP
  • Germany
  • 01 July 2020

As part of its effort to secure potential COVID-19 treatments and vaccines, the government has introduced several amendments to the Infection Protection Act, most recently on 23 May 2020. One of the amendments addresses the compulsory licensing of patents to ensure the supply of pharmaceuticals, medical devices and products for disinfection and laboratory diagnostics.

Scheduling change for cannabis
ENSafrica
  • South Africa
  • 24 June 2020

Health Minister Aaron Motsoaledi recently implemented various changes to Schedules 4, 6 and 7 of the Medicines Act in relation to cannabis and its related components. Although amendments to the Drugs and Drug Trafficking Act remain to be seen, the recent changes to the Medicines Act are a step in the right direction and a significant contribution to the rights of adults to cultivate, possess and use cannabis in private.

Impact of MDR postponement on Swiss medtech industry
Walder Wyss
  • Switzerland
  • 17 June 2020

The European Parliament recently decided to postpone the transition timeline to implement the EU Medical Device Regulation, which was set to expire on 26 May 2020, until 26 May 2021. Although there has been no official statement from the European Union, the competent Swiss authorities consider it as granted that the status quo regarding medical devices continues to apply to Switzerland. This article discusses the presumed impact of the postponement on the Swiss medtech industry.

Donations to the state: gone with the wind, but now back for three years?
ENSafrica
  • South Africa
  • 17 June 2020

On the recommendation of the South African Health Products Authority, the minister of health recently issued Government Gazette 43346, which essentially exempts, under Section 36(1) of the Medicines and Related Substances Act, the free supply of medicines, medical devices and in vitro diagnostics to the state for three years. This exemption also extends to the supply of samples to the state as part of a tender published by the state.

Compliance with medical product shortage reporting requirements during COVID-19 pandemic
Baker McKenzie
  • USA
  • 17 June 2020

The consequences of supply chain interruptions from a compliance perspective vary slightly, depending on the type of product and its indication. Human drug products and medical device products have different requirements for reporting supply chain disruptions and the impact of COVID-19 has cast a bright light on this inequity. Compliance with reporting requirements is therefore paramount during the ongoing pandemic.

Amended Patented Medicines Regulations will come into force on 1 January 2021
Smart & Biggar
  • 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.

How does EPO opinion on patentability of plants and animals affect South Africa?
ENSafrica
  • South Africa
  • 03 June 2020

The European Patent Office Enlarged Board of Appeal may have ended the debate on the patentability of plants and animals which are exclusively obtained by essentially biological processes by ruling that these are not patentable. If South Africa follows the board's interpretation, where essentially biological processes such as natural breeding techniques have been used to produce a plant or animal product, such a plant or animal product (and the process for producing the plant or animal) will not be patentable.

COVID-19 Weekly Report (18-24 May 2020)
International Law Office
  • International
  • 25 May 2020

The impact of COVID-19 is being felt in almost every work area across the globe. In order to keep readers abreast of this evolving situation, ILO's COVID-19 Weekly Report provides insight into the major legal developments of the past seven days, as well as a round-up of our panel of experienced international legal commentators' legislative and regulatory guidance.

First decision under amended PMNOC Regulations: Federal Court finds Amgen's filgrastim patent obvious
Smart & Biggar
  • 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).

Conducting clinical trials during COVID-19 crisis: FAQs
Eversheds Sutherland (International) LLP
  • European Union
  • 20 May 2020

COVID-19 is having a significant impact on clinical trials due to its affects on EU healthcare systems, including limited or no patient contact, restricted access to trial sites and investigational medicinal product shortages. The pandemic is not only compromising effective patient treatment, it will also significantly affect ongoing and planned clinical trials, which are crucial for developing medicines and vaccines. Sponsors and investigators must therefore adapt their management of clinical trials.

Parliament adopts act increasing transparency of managed entry agreements
ALTIUS
  • 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.

COVID-19 Weekly Report (27 April-3 May 2020)
International Law Office
  • International
  • 04 May 2020

The impact of COVID-19 is being felt in almost every work area across the globe. In order to keep readers abreast of this evolving situation, ILO's COVID-19 Weekly Report provides insight into the major legal developments of the past seven days, as well as a round-up of our panel of experienced international legal commentators' legislative and regulatory guidance.

Medical supplies: public procurement procedures in cases of extreme urgency
ALTIUS
  • 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.

Federal government restricts sale of PPE and medical devices for fighting COVID-19
ALTIUS
  • 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.

COVID-19 Weekly Report (20-26 April 2020)
International Law Office
  • International
  • 27 April 2020

The impact of COVID-19 is being felt in almost every work area across the globe. In order to keep readers abreast of this evolving situation, ILO's COVID-19 Weekly Report provides insight into the major legal developments of the past seven days, as well as a round-up of our panel of experienced international legal commentators' legislative and regulatory guidance.

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