The public rights of access on and over land, enshrined in the Land Reform (Scotland) Act 2003, have now been around for almost 14 years. They allow all members of the public a responsible right of access on and across land and inland water throughout the country, often informally referred to as the right to roam. Certain parts of land may be excluded from the rights of access under the Act: restrictions may be allowed, for example, due to planned forestry operations ...
Eliminating Kickbacks in Recovery Act Overview On October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) as part of the SUPPORT Act, which is a comprehensive attempt to combat the opioid epidemic. EKRA established an all-payer anti-kickback prohibition that extends to arrangements with recovery homes, clinical treatment facilities, and laboratories. Unlike the Anti-Kickback Statute (AKS) under 42 U.S ...
President Trump recently signed the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill) and the cannabis industry quickly and widely celebrated passage as clearing the way to sell products containing cannabidiol (better known as CBD). But is it really? As one might expect, this lawyer’s answer is that “it depends.”CBD has become known for its purported health benefits in relation to a wide range of conditions ...
Should States Embrace Telehealth Parity? Parity in telehealth is the notion that health services provided via telehealth technology should be treated equally as health services provided face-to-face. This is consistent with coverage parity, which requires payors to provide the same level of insurance coverage for patient encounters and services, while payment parity (a.k.a ...
In December of 2018, the U.S. Environmental Protection Agency (EPA) and Army Corps of Engineers (Corps) released their much-anticipated draft proposed rule to re-write the definition of “waters of the United States” (WOTUS) (“2018 Rule”). The definition of WOTUS establishes the scope of agency jurisdiction over waters and wetlands under the Clean Water Act (CWA) ...
In two decisions on Friday, the Federal Circuit clarified the law of obviousness-type double patenting (ODP) and provided certainty to biopharma patent owners. In Novartis AG v. Ezra Ventures LLC, the court held that ODP does not invalidate an otherwise valid patent term extension (PTE) granted under 35 U.S.C. § 156 (extending the term of a pharmaceutical patent to compensate for regulatory delays). And in Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc ...
The National Farmers Union, Scotland (NFUS) Joint Venture Hub is designed to act as a match-maker, bringing together enterprising individuals – some of whom have land and some of whom don’t – with a view to pooling their resources to farm together for profit. The Hub can be accessed online via this link. One of the possible vehicles for pursuing a joint venture is by entering into a share farming agreement ...
Institutional Shareholder Services, Inc. (“ISS”) and Glass, Lewis & Co. (“Glass Lewis”) recently released their 2019 proxy voting policy updates. ISS and Glass Lewis are two of the leading proxy advisory services worldwide, and each evaluates and updates their proxy voting policies annually. The key ISS and Glass Lewis updates for the 2019 proxy season are summarized below. ISS ISS published its 2019 Proxy Voting Guidelines Updates on November 19, 2018 ...
The Supreme Court has handed down one of the most anticipated Endangered Species Act (ESA) rulings in recent years. In Weyerhaeuser Co. v. U.S. Fish and Wildlife Serv., the Supreme Court unanimously overruled the Fifth Circuit Court of Appeals, holding that the Fish and Wildlife Service can only designate property that is “habitat” as critical habitat under the ESA ...
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects ...
From ground-breaking discoveries such as penicillin and insulin, to the development of the MRI body scanner and the creation of Dolly the sheep, the first mammal to be cloned from an adult cell ...
The Australian life sciences and biotech sector is likely to continue its resurgence over the next twelve months, with global trends driving strong M&A activity in life sciences and biotech M&A. We have identified 6 key themes for activity in this sector. Three Key Opportunities 1. Demographic Trend According to the Australian Institute of Health and Welfare, healthcare expenditure in Australia is growing faster than population growth and GDP growth ...
To coincide with its 250th anniversary, Shepherd and Wedderburn commissioned the University of Strathclyde’s Fraser of Allander Institute to consider the future challenges and, more importantly, opportunities for Scotland’s economy ...
With investors such as the Scottish Investment Bank, the soon-to-be-launched Scottish National Investment Bank and the Epidarex Life Sciences Fund all increasingly paying attention to the life sciences sector against the backdrop of an increasingly competitive life sciences market in Scotland, now is a great time to consider whether your business is ready for investment, and how it could be standing out in order to attract investors ...
In Scots law, it is possible to acquire certain rights to land – access, for instance – simply by the passage of time. This process is known as “prescription” and is outlined in the Prescription and Limitation (Scotland) Act 1973. There are two forms of prescription: positive and negative. Negative prescription extinguishes certain rights after a period of time ...
Scotland is currently home to one of the largest life science clusters in Europe, with more than 700 organisations based here employing some 37,000 people. With 15 universities producing highly skilled graduates; the NHS as a massive single source of patient data; and world leading research centres in life sciences, Scotland attracts some of the brightest international scientists and life science businesses ...
Not-for-profit Reforesting Scotland’s "Thousand Huts" campaign has spearheaded the regrowth of the hutting community, previously almost entirely eradicated by increasingly strict building regulations. The new Building (Miscellaneous Amendments) (Scotland) Regulations 2017 sets out the framework for ecologically sustainable hut development. What is a Hut? A hut must be a single storey building used as recreational accommodation ...
The international trading market is currently quite favorable to commodity-producing countries such as Brazil. In recent months, the Bloomberg Commodity Index, which tracks daily the performance of main commodities, closed at US$89.49, 1.5% higher than it was at lhe end of 2017 and 6.73% higher than it was 12 months ago ...
Resolution number 217/2018 was published in the Brazilian PTO’s Official Bulletin number 2470, and amends Resolution number 80/2013, which refers to the fast-track examination for patent applications related to products, pharmaceutical processes, equipment and materials related to public health, aiming to accelerate patent applications considered strategic to the Brazilian Public Healthcare System ...
The Danish government has now published its life science growth plan, which aims at making Denmark a leading life science nation in Europe. The growth plan is based on the recommendations submitted by the Growth Team for Life Science. Plesner has previously reported on the topic.1 The growth plan contains 36 initiatives in 6 key areas. One of the many initiatives is a pilot scheme for risk sharing in the drug reimbursement system ...
The Australian life sciences and biotech sector is likely to continue its resurgence over the next twelve months, with global trends driving strong M&A activity in life sciences and biotech M&A. We have identified 6 key themes for activity in this sector. Three Key Opportunities Demographic Trend According to the Australian Institute of Health and Welfare, healthcare expenditure in Australia is growing faster than population growth and GDP growth ...
The Court of Justice of the European Union (CoJ) handed down an important judgment last week on the protection of geographical indications of spirit drinks in a preliminary ruling under Article 267 of the Treaty on the Functioning of the European Union (Scotch Whisky Association (SWA) v Michael Klotz (Case C-44/17)). Facts: Mr Klotz markets a whisky under the designation ‘Glen Buchenbach’, which is produced by a distillery located in Berglen in the Buchenbach valley in Germany ...
As the Trump administration is pushing forward on its deregulatory agenda and, in particular, its efforts to improve the Endangered Species Act (ESA) and its implementation by the US Fish and Wildlife Service (FWS) and National Marine Fisheries Service (NMFS) (together, the Services), the Supreme Court is poised to hear a landmark case on designation of critical habitat under the ESA that could provide some guideposts for the Services’ new regulations ...
On July 11, 2018, then-U.S. Food and Drug Administration Commissioner Scott Gottlieb made a public statement about the agency’s efforts to advance the development of gene therapies.[1] Gottlieb pointed out that the FDA has approved three separate gene therapy products and the agency has issued six scientific guidance documents intended to serve as building blocks of a modern, comprehensive framework for how the FDA can advance the field of gene therapy ...
