Digemid authorized Pfizer the second conditional sanitary registration of the COVID-19 vaccine manufactured in the United States. A total of 4 vaccines authorized by the Peruvian health authority are added to this registry ...
The Ministry of Health and Social Protection issued Resolutions 677, 679 and 681 adopting the biosecurity protocols for the control and management of COVID-19 risk in the transportation, transportation infrastructure and games of luck and chance sectors. These protocols are complementary to the general biosecurity protocol adopted through Resolution 666 of 2020 and to other measures implemented by corresponding companies ...
The Bay Area counties of Alameda, Contra Costa, Marin, San Francisco, San Mateo, and Santa Clara, and the City of Berkeley have jointly issued new Shelter-in-Place orders superseding their existing March 31, 2020 Shelter-in-Place orders ...
When a patent is issued under the seal of the United States Patent and Trademark Office, it is signed by the Director of the USPTO or an Office official. The patent contains a grant to the patentee, and a printed copy of the specification and drawing is annexed to the patent and forms a part of it ...
Natural products play an important role in pharmaceutical innovation. They are active components in many medicines. For example, nearly half of the small molecules used to treat cancer are natural products or directly derived from natural products.1 They are also components of vaccines. The pharmaceutical industry is constantly seeking access to natural products and the traditional knowledge associated with them ...
The National Treasury (“NT”’) published its draft Taxation Laws Amendment Bill with accompanying Explanatory Memorandum on 28 July 2021 (the “draft Bill”). By now it is well known that the draft Bill contains a fairly radical proposal: section 20 of the Income Tax Act, 1962 (“the Act”) will be amended to limit the amount of an assessed tax loss that may be set-off against taxable income ...
Namibia’s emerging green energy industry has the potential to create thousands of jobs and contribute billions to the country’s GDP. In November 2022, the Namibian Government released the Namibia Green Hydrogen and Derivatives Strategy Report (the “GH2 Strategy Report”) which drew significant attention from locals, who are anticipating the development of legislation for Namibia’s green hydrogen sector ...
New technology is most often associated with telecommunications, IT or robotics. Food is seen as a group of products in which innovation is little important, because it is believed that consumers are mostly concerned with prices and quality, but not innovations. However, the dynamic growth in market share of functional foods calls for a critical review of myths that have arisen around R&D projects in the food sector ...
On 13 June 2013, the Supreme Court of the United States handed down its unanimous decision in the ongoing case of Association for Molecular Pathology et al v Myriad Genetics, Inc. et al 12-398, 569 US __ (2013). This case is the first brought in the US directly challenging the patentability of human genes and for that reason is extremely important to any entity involved in the biotechnology industry which relies on human genetics research as part of innovation strategy ...
On May 7, 2020, the amendment to Decree No. 466 was published in the Official Gazette, which approves the Regulation of Pharmacies, Drugstores and other pharmaceutical establishments, regarding the sale of medicines through electronic means. Particularly, article 8 of said Decree is modified, in order to allow the electronic sale of medicines in pharmacies, incorporating the following sentence: "Pharmacies may dispense medicines through electronic means ...
Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017 ...
On February 25, 2021, the Ministry of Health and Social Protection issued Resolution 223 of 2021 (the “Resolution”) to update the general biosecurity measures set for the management of Covid-19 in Colombia. The main novelties included in this regulation are mentioned below: 1. Scope The Resolution extended the scope of the general biosecurity measures to all "social and economic activities carried out by individuals" ...
On Monday, June 3, Governor Gretchen Whitmer and the Michigan Department of Agriculture and Rural Development (MDARD) announced MDARD’s decision to allow for commercial solar energy development on land currently enrolled in the Farmland and Open Space Preservation Program, commonly known as PA 116. PA 116 was established in 1975 and is designed to preserve farmland and open space in Michigan ...
Acquisition of intended exclusively for the production of parenteral bags INFARMED - the Portuguese National Authority for Medicines and Healthcare Products (“Infarmed”) has recently adopted Decision 089/CD/2022, concerning the regulatory framework for the acquisition of medicines without a national Marketing Authorisation (“AIM”), intended exclusively for the production of parenteral bags ...
Fast-growing e-commerce has changed lifestyles and invented new ways of consumption, amid which demand has rapidly increased for Internet-based medical services such as online drug sales and online medical diagnosis. Since the regulation and promotion of "Internet-based healthcare services" was included as part of the Outline of the "Healthy China 2030" Plan, China's Internet healthcare industry has been flourishing, channeled by a series of favorable policy decisions ...
The Scottish Government, SEPA and industry have identified significant opportunities for the growth of the finfish aquaculture sector in Scotland. This expansion is an express policy objective of the Scottish Government, and was confirmed through the National Marine Plan published in 2015. Nevertheless, whilst there has been some growth in the sector since the plan’s publication, the sector has yet to realise its full potential ...
Agricultural and rural settings present significant health and safety risks, which must be carefully managed and mitigated by employers and landowners operating in the sector. This was brought into sharp focus after two fatalities led to prosecutions following investigations by The Health and Safety Executive (HSE). Prosecution one In February, a farmer was prosecuted after a tragic fatal incident on farmland in Leeds ...
There has been concern within the agricultural industry for some time the race to achieve carbon net-zero is leading to the loss of productive agricultural land to forestry purchasers. Another perceived threat is from investors, both private and institutional, looking to invest in natural carbon, for example, by way of peatland restoration and rewilding projects ...
On 1 September 2023, the legal framework for seed farming in Russia will take effect. At present, lawmakers are preparing highly controversial regulations, which essentially aim to limit foreign investments in the Russian seed farming sector. The central idea is to implement a set of rules that require Russian companies involved in the production of agricultural plant seed varieties and hybrids to localize their activities (“Localization Rules”) ...
Denmark has a large life science sector, including a number of biotech and pharmaceutical companies and research activities. The sector is highly regulated and covered by extensive and complicated statutory requirements, executive orders and ethical standards. Denmark has incorporated most of the EU regulation and Danish law is thus to a large extent in conformity with the general EU regulation and practice of, for example, the European Medicines Agency (‘EMA’) ...
Although the U.S. Department of Justice (DOJ) reported a slight decrease in settlements with life sciences companies in FY2019 (the most recent year for which data is available),[1] this likely will be a temporary trend. Several significant settlements and investigations in 2020 provide key insights into government enforcement priorities as we look toward 2021 ...
CRIMINAL Counterfeit VaccinesBy Andre Augusto Mendes Machado and Mariana Murad Leiva Counterfeiting vaccines may lead to criminal liability, usually for the crime foreseen in article 273 of the Brazilian Penal Code, that punishes with imprisonment from 10 to 15 years in addition to the payment of a fine the acts of "falsifying, corrupting, adulterating or modifying products intended for therapeutic or medicinal purposes" ...
Welcome to the Life Sciences & Healthcare Newsletter, a publication prepared by our multidisciplinary team dedicated to the Healthcare industry, under the coordination of partners Lior Pinsky and Renata Fialho de Oliveira. INSURANCE ANS establishes operating rules for electronic administrative proceedings, effective as of end of March 2021 Andrea Piccolo Brandão In accordance with Decree No. 8,539, of Oct. 08, 2015 ("Dec ...
Last month the Scottish Government published “Land Reform in a Net Zero Nation”, a consultation paper on a new Land Reform Bill. The paper sets out the proposals for the bill and seeks views on various related issues, including measures aimed at “large-scale holdings”, changes to subsidies, the introduction of a new type of agricultural tenancy, and transparency of land ownership ...
