The Italian Medicines Agency recently opened a public consultation on national templates for medicinal products and medical devices to be used in clinical trials carried out in Italy. The public consultation will hopefully help to clarify whether such templates should be considered mandatory and to what extent they may be replaced by sponsors' templates or be subject to negotiation and amendments.
Throughout 2018 the Department of Justice (DOJ) continued to ring the clarion call for cooperation and sought to provide some certainty, consistency and coordination regarding the incentives offered to companies that provide voluntary disclosures. In particular, the DOJ centralised its guidance memoranda into what is now known as the Justice Manual. The DOJ's goals were to identify redundancies, clarify ambiguities, eliminate surplus language and update the manual to reflect current law and practice.
Under the EU Medical Device Regulation and the EU In Vitro Diagnostic Medical Device Regulation, organisations that want be recognised as notified bodies must obtain a new designation. According to Assobiomedica (the association of medical device suppliers), the number of notified bodies in Italy that have applied for said designation is low. This has led to questions around what will happen if notified bodies fail to obtain the new designation and what liability they will face regarding manufacturers and patients?
Government attorneys now have additional discretion in False Claims Act civil cases to award cooperation credit to a corporation that meaningfully assists the investigation without necessarily identifying every individual person outside of senior management involved in the alleged misconduct. The new policy reflects the reality of modern corporate investigations and encourages realistic cooperation efforts without compromising the Department of Justice's policy of holding individuals accountable.
After the election of President Donald Trump, many observers wondered whether the US Department of Justice (DOJ) would change the way in which it enforces the Foreign Corrupt Practices Act. As the halfway point of Trump's first term in office approaches, it seems that the DOJ has not made any dramatic changes to the enforcement philosophy followed during prior administrations.
The Lazio Administrative Court recently decided that, as a rule, parallel importers of medicinal products have no right to change the trademark affixed to products in their country of origin unless this change is strictly necessary due to safety grounds or national regulatory restrictions. The court found that the right to undertake the parallel import of medicinal products should not unduly take advantage of the national reputation and trust built by the marketing authorisation holder in the products' state of origin.
The Italian Competition Authority (AGCM) recently launched an investigation into the online sale of dietary supplements in Italy based on claims of non-compliance with the relevant regulatory provisions, resulting in misleading actions. The AGCM's role in this context is to ensure that consumers obtain accurate information concerning dietary supplements so that they can make informed decisions concerning these products.
When a legal team needs to find the facts behind fraud and corruption allegations in a government investigation, technology can drive substantial new efficiencies. By filtering and evaluating vast amounts of information, artificial intelligence can effectively sort text messages, audio files, emails and other unstructured data into manageable groups; identify potential relationships between parties accused of fraud or corruption; and recognise patterns of frequency or timing, which may support a client's defence.
Compliance officers often report to the legal department or are staffed with qualified lawyers, making it difficult to distinguish when the compliance officer is serving in a legal capacity, rather than a compliance one. However, drawing a clear distinction between these functions, conducting internal investigations under the direction of counsel and making the legal purpose of communications or documents clear will make the best possible record to show that documents should be protected by privilege.
After seven years, the Supreme Court finally ended the first product-related class action promoted in Italy relating to a medical device. The decision is noteworthy, despite the small sum awarded, because very few class actions have been declared admissible to date and even fewer cases have been upheld on the merits due to strict admissibility requirements.
With few Foreign Corrupt Practices Act (FCPA) corruption investigations resolved under the Trump administration's watch, it is too early to weigh up how the administration will affect enforcement or settlements in the long term. On its face, the new FCPA Corporate Enforcement Policy signals a more business-friendly approach by removing the spectre of a monitor in many situations and by committing to a presumption of a declination in certain circumstances.
Companies now have even greater incentives to have strong, meaningful Foreign Corrupt Practices Act compliance programmes. When the deputy attorney general recently announced the new enforcement policy that will guide the US Department of Justice, he made it clear that the government wants to create incentives for companies to police themselves when it comes to bribery and corruption.
Two recent cases before the Department of Justice (DOJ) have sent a signal that the DOJ may become more proactive in combating small-business contracting fraud. These cases underscore the importance of ensuring that small-business eligibility representations are accurate, as the penalties for misrepresentation can be severe.
For energy, mining and resources companies, the cost of corruption – and getting caught – is real. Energy and mining companies, along with other resources companies, remain a major focus of bribery and corruption investigations worldwide. The government wields a potent weapon against bribery and corruption in the form of the Foreign Corrupt Practices Act.
In the past, compliance and remediation in the context of healthcare investigations were typically seen as afterthoughts. However, compliance efforts are now being more closely scrutinised by prosecutors. The Department of Justice recently issued an 11-part series of questions styled as guidance on corporate compliance programmes. Interestingly, it is a series of questions, not a series of answers. Companies are going to have to work the answers out themselves with their compliance departments and counsel.
In recent years, US and Western European military spending has decreased as military spending in other parts of the world has risen. As a result, aerospace, defence and government services companies increasingly rely on sales to foreign governments to grow business revenue and are thus at a more significant risk of investigation for violations of the Foreign Corrupt Practices Act.
To undergo a Foreign Corrupt Practices Act investigation entails significant risk. Since 2008 at least 10 corporations have agreed to pay more than $300 million in penalties to resolve such investigations. Defence costs associated with a global bribery or corruption investigation can also run into the millions before any penalties are assessed. A number of developments that emerged during 2016 will have broad implications for the coming year.
As the Senate prepares to confirm Senator Jeff Sessions as the new attorney general and to consider nominations for other high-level positions in the Justice Department, there are many questions – and few answers – about how the new leadership in the Justice Department will approach the prosecution of white collar crime during the Trump administration.
The Department of Justice (DOJ) recently announced a landmark resolution concerning violations of the Foreign Corrupt Practices Act. The DOJ and the Securities and Exchange Commission entered into a $413 million settlement with one of the world's largest hedge funds. This settlement indicates that the DOJ intends to enforce the act strictly with little regard for the industry involved or the financial consequences.
Since January 2009, the government has recovered more than $30 billion through False Claims Act cases, more than half of which was recovered from cases involving alleged fraud against federal healthcare programmes. False Claims Act cases are now more complex, lucrative and healthcare focused than ever – a far cry from the act's humble beginnings as a solution to the problem of fraudulent sales to the military during the American Civil War.