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 ...
The High Court judgment in Friends of the Irish Environment v. An Bord Pleanála (delivered in 2018 by Meenan J) decided that if a Section 5 referral is made by a third party, then the owners and occupiers of the lands must be identified and served with notice of the referral, and given an opportunity to make submissions in accordance with basic fair procedures ...
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 ...
The UKCS is the largest decommissioning market in the North Sea. There are around 475 fixed facilities, over 10,000 kilometres of pipeline and approximately 5,000 wells. These will all need to be decommissioned over the next 30 years, when they reach the end of their economic life, at an estimated cost of £59.7 billion ...
In Australia, we're seeing enormous opportunities and some policy challenges in renewable energy ...
Feeling the heat: the draft Climate Change Bill, 2018 Earlier this year, the South African Minister of Environmental Affairs (the “Minister”) published the draft Climate Change Bill, 2018 for public comment. Since then, the Department of Environmental Affairs (“DEA”) has undertaken a road show across the country to solicit comments to the Bill and held further bilateral meetings with stakeholders earlier this year ...
On 1 January 2020, the maximum allowable sulfur content of marine fuels will be drastically reduced from the current 3.50% to 0.5% m/m. 2020 is rapidly approaching, but is the shipping industry really prepared? In this article, we provide an overview of the regulations and the main alternatives for compliance that shipowners and operators are faced with. Introduction On 1 January 2020, the maximum allowable sulfur content of marine fuels will be drastically reduced from the current 3.50% to 0 ...
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 California Court of Appeal recently upheld a lower court decision that, as we previously discussed, expanded the scope of the "public trust doctrine" to include groundwater. In Environmental Law Foundation v. State Water Resources Control Board, the appellate court held that agencies permitting groundwater pumping must consider how pumping may harm "public trust interests ...
In the Loop: With the Hanson Bridgett Government Group Not long ago, the state of California suffered through a crippling six-year drought, and water conservation was the name of the game. But California’s last two winters have been wetter, and water conservation feels a lot less urgent when the stuff is literally falling from the sky ...
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 ...
