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 ...
To help prevent disruptions in the food supply-chain during the COVID-19 pandemic, the FDA issued a temporary policy for Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements. The policy states that the FDA will temporarily not enforce FSMA supplier verification onsite audit requirements if other appropriate supplier verification methods are used instead ...
The FDA issued immediately-in-effect guidance to accelerate the development of certain laboratory tests for the urgent need caused by SARS-CoV-2. The FDA provides recommendations, among others, for serological tests, puts forth a policy for states to take responsibility for tests, and announces enforcement discretion for commercial manufacturers using new commercially developed tests prior to the FDA granting an emergency use authorization, under certain circumstances ...
FDA Takes Action to Increase U.S. Supplies in Response to COVID-19. The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices. The FDA is engaging the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S ...
Farms run as a family business tend to follow a partnership structure. However there is often a reluctance to commit the terms of the partnership to paper or else to keep the terms of an existing agreement up to date. However ensuring that your Partnership Agreement is up to date and reflects your wishes is essential for succession and tax planning purposes.Partnership Agreements Farming businesses can use different business structures ...
I have recently been advising a farmer in relation to an appeal against a department penalty imposed for an alleged breach of GAEC (Good Agricultural Environmental Conditions). These are the conditions farmers claiming agricultural support payments must comply with, and which are designed to safeguard soils, habitats and landscape features on agricultural land. A breach of GAEC can lead to financial penalties being imposed on the farmer ...
For businesses who care about their brands, Pofma may be not be such a bad idea after all.Beyond Meat Inc. makes cows happy and cardiologists sad. Its Beyond Burger uses no meat and has no cholesterol, and contains less fat, fewer calories and more protein than a typical burger ...
We would like to inform you that the Russian President has signed amendments to Article 1360 the Civil Code of the Russian Federation ('Russian Civil Code'), in terms of providing compulsory licenses to use an invention, utility model or industrial design ('patent rights') on 30 April, 2021. The amendments came into force on 11 May, 2021 ...
The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”)[1] was enacted on October 24, 2018. Among other things, the SUPPORT Act amended the Physician Payments Sunshine Act (“Sunshine Act”)[2] to expand the definition of “covered recipients”[3] for payment tracking and reporting purposes ...
Introduction The rapid spread of COVID-19 pandemic has led to a significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), masks for social use (textile articles) and other products destined to prevent the spread of the disease. As a result, it became clear that there was insufficient supply to meet existing needs during the state of emergency and the subsequent period ...
Introduction An EU Regulation on the making available on the Union market as well as export from the Union of certain commodities and products associated with deforestation and forest degradation (“Deforestation Regulation”) was agreed upon by the EU legislators in December 2022. The European Parliament has now green-lighted the Provisional Agreement at this month’s plenary session ...
The EU regulator has harmonized the maximum levels for tetrahydrocannabinol (THC) in hemp seeds throughout the Union within the food contaminants framework. This EU harmonization puts pressure on conservative national food laws such as the Belgian Royal Decree of 31 August 2021, which treats hemp seeds as a prohibited food.The situation in Belgium, however, is changing to better align it with EU law ...
Hemp seeds have been eaten in the EU for a long time. The seeds may contain trace amounts of tetrahydrocannabinol (THC) because this cannabinoid is a natural constituent of the cannabis plant from which the seeds originate. The EU regulator has decided to harmonize the maximum levels for THC in hemp seeds throughout the Union within the food contaminants framework. Commission Regulation 2022/1393 of 11 August 2022 amends the annex to Regulation No1881/2006 on food contaminants to this effect ...
Horizon 2020 is the new EU Framework Programme offering more than €70bn funding for Research and Innovation initiatives over the period 2014 to 2020 and covering every stage of the innovation process from research to market uptake. Ivan Waide and Kate Keith, IP & Technology lawyers at A&L Goodbody, take a closer look at the programme, including opportunities available to Northern Ireland businesses and research organisations ...
One way to change the law fast is to amend or repeal statutes in budget legislation. That is what the federal government of Canadadid in 2009, 2010 and 2011. Federal programs, staff positions and budgets for environmental science, conservation and protection have been eliminated. That leaves a lot of responsibility with the provinces and territories, and many open questions for industry. This article describes what has happened and identifies what to look out for ...
Ministry of Agriculture, Cattle Raising and Supply publishes Ordinance establishing working group for the development of the strategic agenda for sustainable agriculture. On February 1, 2021, the Ministry of Agriculture, Cattle Raising and Supply ("MAPA") published Ordinance No. 26 ("Ordinance"), establishing the working group for the development of the strategic agenda for sustainable agriculture ...
The World Bank Group has released Enabling the Business of Agriculture 2017. The report presents data on legal barriers for farmers, entrepreneurs and businesses operating in agriculture in 62 countries and across the topics of land, seed, fertilizer, machinery, water, livestock, finance, markets, transport, and information and communication technology (ICT). SyCipLaw's Rose Marie M. King-Dominguez, Alan C. Fontanosa, Franco Aristotle G. Larcina and Ruben P ...
On September 29, 2023, Decree No. 4, dated January 25, 2023 (the "Regulation"), issued by the Ministry of the Environment (the "Ministry"), was published, coming into force the Emission Compensation System for stationary sources subject to Green Tax[1] (the “System”). The System promotes the development of emission reduction projects (the "Projects") ...
Earn-outs are a commonly used payment mechanism in overseas and cross-border M&A transactions. Through earn-outs, transacting parties can set flexible metrics to adjust the buyer’s payment obligation and thereby allocate the risks and benefits between the buyer and seller ...
The transformational power of AI is set to redefine the modus operandi across various sectors, including healthcare. The life sciences sector in particular are already realising the benefits of AI. Their shared experiences offer other health organisations the opportunity to pre-empt some of the challenges associated with AI. The rapid and profound impacts emerging from AI advancements are truly staggering, leaving no room for delay ...
COVID-19 has brought about new economic uncertainty that is disrupting supply chains, from farmers and ranchers to cooperatives, from processors to grocery stores, and all of the way down to consumers. Even solvent purchasers of agricultural products may begin to request extensions of payment terms from agricultural producers, impacting growers’ cash flow and balance sheets ...
On 30 April 2020, the European Commission adopted three implementing regulations allowing temporary derogations from the strict cartel prohibition provided for by EU competition law in three specific agricultural sectors: dairy, potato and live plants and flowers. The latter sector is said to broadly cover “live trees and other plants, bulbs, roots and the like, cut flowers and ornamental foliage” ...
The Minister of Health is issuing successive anti-export lists covering an increasingly wide catalogue of products at risk of shortages. This is to ensure access to drugs and medical devices for patients in Poland, especially during the difficult time of the COVID-19 pandemic ...
