On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
In this report, you will find a summary of two important decrees published yesterday in the Official Gazette. Regulatory Decree of Law No. 27,350 of medical and scientific research on the medicinal use of the cannabis plant and its derivatives By means of Executive Branch’s Decree No ...
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 ...
IP landscape While the world is in the grip of the deadly COVID-19 pandemic, the patenting of pharmaceutical and biological compositions and the launch of generic products is even more hotly debated than before, particularly in the world's developing and least-developed countries ...
If a branded medicine and its generic version are put on the EEA market by economically linked undertakings, is a parallel importer then allowed to rebrand and repackage the imported generic version as the branded reference medicine? This has been a hotly debated issue in recent years and recently led the Brussels Court of Appeal (CoA) to refer three questions to the European Court of Justice (ECJ) (Cases C-253/20 and C-254/20) ...
The U.S. Department of Justice (DOJ) announced on October 29, 2020 it reached a more than $9.2 million settlement with Medtronic USA Inc. to resolve allegations it violated the False Claims Act (FCA) and Open Payment Program.[1] Specifically, Medtronic agreed to pay $8.1 million to resolve FCA allegations it paid kickbacks to induce a South Dakota neurosurgeon to use its SynchroMed II intrathecal infusion pumps ...
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 ...
Coronavirus Digest no. 4 Patents and other intellectual property rights 1. Patents Moderna reveals that it may not hold the patent rights for the vaccine against Covid-19, because it was not the first to file the patents. This came after the US National Institute of Health claimed co-ownership of the rights to this vaccine. Read more here ...
The Department of Justice is stepping up its scrutiny of health-care fraud, especially in testing laboratories, during the Covid-19 pandemic. Former federal prosecutor Jason Mehta, a partner with Bradley, says now is not the time to tout profits over patient care and offers insights on compliance. In the midst of a global pandemic, much attention and praise is rightfully being showered on health-care providers ...
The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020. This nonbinding guidance is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services. The guidance advises vaccine development and licensure following the standard trial progression but on an accelerated timeline ...
As of July 1, the Russian requirements on digital labelling of medications and transmitting the data on medications’ turnover to the Chestny ZNAK system have become mandatory.Start of mandatory digital labellingFrom 1 July, all market participants of the pharmaceutical industry (manufacturers, distributors, pharmacies, etc.) must reflect information on all operations made with medications in the monitoring system ...
The impact on human health of the global pandemic of the SARS-CoV-2 virus and the resulting disease termed COVID-19 cannot be overstated. Not since the influenza pandemic of 1918 have so many regions of the world been so acutely impacted by a single pathogen. Society in 2020 has the advantage of a more sophisticated biotechnology industry. Testing is considered crucial in controlling (or at least mitigating) the pandemic, and tests from several companies have become widely available ...
On June 16, 2020 the German government released its Corona-Warn-App. There are some key points employers should be aware of concerning the app: NO OBLIGATION FOR EMPLOYEES TO USE THE APP ON THEIR PERSONAL SMARTPHONES An employer may be thinking about instructing its employees to install and use the Corona-Warn-App on their own devices to reduce the infection risk among its employees. That is not permitted ...
Pharmaceuticals and medical devices in Malaysia are governed by the following main legislation and regulations:the Sale of Drugs Act 1952 (SODA 1952);the Control of Drugs and Cosmetics Regulations 1984 (CDCR 1984);the Dangerous Drugs Act 1952 (DDA 1952);the Poisons Act 1952 (PA 1952);the Medicines (Advertisement and Sales Act) 1956 (MASA 1956); andthe Medical Device Act 2012 (MDA 2012) ...
Vietnam, a country of 97 million people, has been widely recognized for its successful handling of the novel coronavirus outbreak. On January 27, as the country celebrated the Lunar New Year holiday, Prime Minister Nguyen Xuan Phuc declared war on the coronavirus, having said "fighting this epidemic is like fighting the enemy". The Prime Minister and his cabinet acted expediently in controlling the spread of the virus ...
MDR postponement On 17 April 2020 the European Parliament decided to postpone the transition timeline to implement the EU Medical Device Regulation (MDR), which was set to expire on 26 May 2020, until 26 May 2021. The EU MDR postponement was published in the Official Journal of the European Union and entered into force on 24 April 2020 ...
This time we address solutions from the front lines: devices for remote diagnostics which can improve effective detection of the coronavirus and also unburden the health service in other areas. These solutions can also serve as aproving ground for the regulatory approach to oversight of algorithms. The immediate inspiration for writing this text was asolution from the company StethoMe presented at the DemoDay organised by the MIT Enterprise Forum CEE ...
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 ...
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 ...
As corporate policyholders continue to submit claims to their insurers for business interruption and related losses sustained from the COVID-19 pandemic, insurers appear to be denying such claims routinely where the policies at issue contain exclusionary language specific to viruses — whether in stand-alone virus exclusions or other types of exclusions ...
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 ...
In the context of COVID-19 pandemic, the field (on-site) tax audits in Russia are currently postponed, but once all restrictions are lifted, the tax authorities can start auditing Russian companies and replenishing the National Budget by redoubling their efforts. The pharmaceutical industry could be in the focus of the tax authorities and, above all, they could start with auditing of the contractual structures used for organizing clinical trials and promotion of pharmaceutical products ...
Today, May 10, Legislative Decree No. 1486 that establishes new provisions, and modifies and/or expands various regulations for the effective execution of investments by public entities has been published ...
