The regulation of advanced therapy medicinal products The development of medicine, biomicrobiology and biotechnology has led to the emergence of a relatively new category of medicinal products that use gene therapy, somatic cell therapy and engineered tissues for preventing, treating or even curing human diseases. The novelty, complexity and diversity of such products has demanded new regulatory tools to allow an appropriate balancing of the risks and the benefits for the patients. EU and UK legislature regulates this category of products as ‘advanced therapy medicinal products (ATMPs)’ in order to ensure the highest level of protection of public health and to take into account their specific challenges, in particular with regard to clinical trials, manufacturing and pharmacovigilance. However, the regulation of the tissues and cells and of genetically modified organisms (GMOs) which are used as starting materials for ATMPs remains national and therefore differs from one Member State to another. Such differences have led to a complex regulatory landscape for ATMPs. This Practice Note explores the definition of an ATMP, the regulation of ATMPs, considers the exceptions to marketing authorisation (MA) requirements for ATMPs and looks at the manufacturing, distribution and import/export of ATMPs under EU and UK law. EU and UK regulatory frameworks As a consequence of Brexit, the body of EU-derived laws has been preserved and converted into UK domestic law with effect on IP completion day
Structure and key features of a solar project finance transaction Introduction and key benefits of solar As the appetite for renewable energy has grown exponentially over the past decade, solar power projects have become increasingly prevalent. Of the two types of solar projects, photovoltaic (PV) and concentrated solar power ‘CSP), PV is the most common type, rising from an installed capacity in the UK of 95MW in 2010 to around 13,530MW by the end of June 2021. The low installation costs and short build times of solar PV projects have made them an attractive option for investors and sponsors in the energy sector. A few of the key advantages of solar power are worth noting at the outset. These include: • sunlight is an infinite resource that can be reliable as an energy source (depending on the climate of the project’s location) and it does not generate carbon emissions. As many governments across the world increasingly commit to reducing emissions to slow climate change, these features become more decisive • solar energy can be stored in molten salts, batteries, or thermal energy storage systems in order to prevent wastage from oversupply. As technology surrounding battery storage develops, this becomes more advanced and less expensive to acquire • building PV solar projects is simple mechanically, and therefore deploying the infrastructure can be rapid and relatively low-cost • maintenance costs are also low in
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