Net zero targets now cover in excess of two thirds of global GDP and over a fifth of the world's largest public companies, according to the latest report published by the Energy and Climate Intelligence Unit and Oxford Net Zero. This global shift towards net zero has reshaped the development landscape with demand for sustainable buildings being driven not only by regulators, but by investors and occupiers ...
The hosting of COP26 in Glasgow this year shines a spotlight on the UK in relation to sustainability performance, applying more pressure on organisations to demonstrate their green credentials and to encourage the development and usage of sustainable technologies in the race to net zero. One sector in particular that is leading the charge on decarbonisation is the affordable housing sector, but barriers exist and challenges endure ...
The UK will host the UN’s COP26 climate change conference in November 2021, but what is a COP – and what happened at the previous 25 COPs? 15 April 2021 marks 200 days until COP26 is due to start. Taking place in Glasgow from 1-12 November 2021, COP26 is the 26th session of the Conference of the Parties to the UN Framework Convention on Climate Change (UNFCCC) ...
As with other parts of the UK, the last 18 months have seen a period of exceptional market activity in the living sector in Northern Ireland, despite the economic challenges of Covid. Much of that activity has in fact been driven by the societal challenges and behavioural shifts brought about by the pandemic ...
Almost one year into the new funding round for English affordable housing, we consider how the new Homes England shared ownership lease may affect living sector stakeholders. What’s happened to shared ownership leases? April 2021 heralded a major change to shared ownership (‘SO’) leases in England. Following a consultation process, Homes England released a new suite of model SO leases ...
IN OUR JUNE 2005 “FDA WATCH” column, we provided an overview of the regulatory, political, and scientific landscape for follow-on biological products in the U.S. As reported a year ago, the biogenerics debate centers around whether generic biologics are scientifically possible (i.e ...
On Capitol Hill, U.S. lawmakers are considering legislation that would authorize the U.S. Food and Drug Administration (FDA) to approve generic versions of biological products. Representative Henry Waxman (D, CA), of “Hatch-Waxman” fame, has introduced the “Access to Life Saving Medicine Act” (H.R. 1038) to advance this change to U.S. law. In introducing the legislation, Rep ...
Hospitals and health systems are on the frontlines fighting the COVID-19 pandemic. But, behind the scenes, they are grappling to sustain operations and finances significantly impacted by the state of the economy. In the latest version of our PointbyPoint podcast, Waller’s Ken Marlow and Eb LeMaster, managing director at Ponder, discuss the various factors impacting hospitals and health systems today ...
As Hurricane Harvey continues to cause far-reaching disruptions, it is important to understand how to effectively assert or respond to assertions of force majeure. This summary outlines the steps to take to assert force majeure, and initial considerations for those who have received several notices of force majeure from counterparties ...
Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
Condominium and villa investors will have a more affordable, flexible and attractive opportunity to invest in the Turks and Caicos Islands’ (TCI) real estate following the enactment of the Fractional Ownership Ordinance. The Ordinance has not yet come into force, but shall do so once a notice has been published in the gazette, to this effect ...
After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
How has the use of digital technology, as a result of the COVID-19 pandemic, contributed to the rise in fraud? As a result of the COVID-19 pandemic, businesses experienced a rapid and significant increase in the use of digital technology. Bearing in mind health concerns, as well as business continuity, many businesses began to shift to widespread remote working environments ...
Judgement of the European Court of Justice in case C-212/03 – Commission v. France, dated 26 May 2005 The Commission acted against France on the grounds that certain French rules on the importation of medicines are contrary to Article 28 of EC Treaty on the free movement of goods. The relevant national rules and administrative practice required a licence for the importation of medicines for personal use in France ...
The HHS Office for the National Coordinator of Health Information Technology issued an interim final rule on October 29, 2020, extending the compliance date for the information blocking rule under the 21st Century Cures Act to April 5, 2021 ...
It is evident that the current lockdown is having an unprecedented slowdown in the movement of persons between EU Member States. This is not due to a restriction which was imposed by the EU itself but because of the restrictions which the Member States themselves imposed through their respective Public Health officials. It is noticeable that the legal restrictions on immigration were driven by the Member States' individual rules rather than by a general guideline from the EU ...
The rise of e-commerce and the struggle many brick-and-mortar retail stores face is nothing new. Customers are increasingly choosing to shop for clothes, furniture and even groceries from the convenience of their own homes. More recently, however, this shift in the way consumers shop has given rise to new types of retail stores – small showrooms and “pop-up shops ...
In commercial real estate transactions, time is money, execution is everything and projects generally do not move forward without a mortgage loan. Lenders and their counsel should view a project as if the lender is the eventual buyer, owner and seller. For developers, considering the transaction from a lender’s point of view can save them considerable time and money and expedite loan closing ...
April 17, 2023 By: Meghna Parikh ALERT: Recent guidance from the Food and Drug Administration (“FDA”) clarifies a procedural issue for premarket submissions related to cybersecurity of medical devices and emphasizes the importance of collaboration between the FDA and medical device manufacturers. Providers using medical devices in their practice should pay attention to these rulings because they impacts the providers’ ability to educate and engage their patients ...
One of the most common questions I receive from clients is around the termination of leases, with confusion reigning around the terminology and procedures used in Scotland. It is not surprising that when given a remit to consider the law of commercial leases, the Scottish Law Commission (SLC) first turned its attention to the law relating to the termination of leases at expiry. In October 2022, following consultations, the SLC published its Report on Aspects of Leases: Termination ...
On 1 August 2014, the Queensland government released consultation drafts of the Planning and Development Bill 2014 (P&D Bill) and the Planning and Environment Court Bill 2014 (PEC Bill). The draft Planning Bills are proposed to replace the Sustainable Planning Act 2009 (Qld) (SPA) and seek to implement a new land-use planning and development assessment system that promotes prosperity through balancing economic growth, environmental protection and community wellbeing ...
This year, the Federal Trade Commission (the “FTC”) and the Department of Justice (the “DOJ”) have been modifying antitrust guidance related to healthcare, and recently enacted three notable changes. First, the FTC and DOJ jointly issued updated Draft Merger Guidelines (the “Draft Guidelines”) to address the way the agencies evaluate a merger to determine its effect on competition ...
