Latest updates

FDA issues draft guidance on clinical research of cannabis and cannabis-related products
Baker McKenzie
  • USA
  • 05 August 2020

The US Food and Drug Administration recently issued its draft guidance on clinical research for the development of drugs that contain cannabis or cannabis-derived compounds of botanical origin (as opposed to synthetic). The guidance provides some clarity on the use of cannabis in clinical research in light of the changes made by the Agriculture Improvement Act 2018, which federally legalised hemp and derivatives that contain no more than 0.3% by dry weight of THC.

Tobacco yes, marijuana yes, vaping no: absurd approach to major health problem
Sanchez DeVanny Eseverri SC
  • Mexico
  • 05 August 2020

The Mexican health authorities argue that the use of vaping products constitutes a health risk and promotes tobacco product use by smokers and non-smokers alike. Based on this interpretation, the health authorities have made several attempts to prohibit the sale and marketing of vaping products. Most of these attempts have been challenged by individuals or legal entities engaged in the tobacco industry, with favourable outcomes in the federal courts and the Supreme Court of Justice.

African Union publishes COVID-19 vaccine strategy
ENSafrica
  • 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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