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.
The Supreme Court of Justice recently declared that an article of the Federal Telecommunications and Broadcasting Law – which provided that the minimum fine for any violation of the law not otherwise expressly penalised in another law was 1% of the offender's annual income – to be unconstitutional. This declaration may signal that the court intends to participate more regularly in shaping Mexico's legal framework in order to rectify deficiencies created by Congress.
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.
In view of recent policy changes relating to hydrocarbons and gasoline distribution via pipelines, liability for the remediation of soil and water contamination derived from hydrocarbon spills and leaks at storage terminals and pipelines has become a hot topic. These policy changes have largely been aimed at tackling criminal activities that have contributed to soil and water contamination, such as fuel and hydrocarbon theft.
In March 2018 the Fintech Law, which aims to mitigate the risk of money laundering and terrorist financing, was published in the Federal Official Gazette. Subsequently, in January 2019 the National Commission for Regulatory Improvement published draft amendments to the anti-money laundering rules which apply to the traditional banking industry in order to incorporate the new concepts created by the Fintech Law.
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?
One of the first actions that the new federal government administration undertook after taking office in December 2018 was to prepare the expenses budget in accordance with the new president's austerity principles. After heated discussions, the budget was finally approved on 24 December 2018. Shortly after, the Federal Telecommunications Institute filed a constitutional challenge in which it claimed that the budget will affect its ability to perform its constitutional regulatory functions.
In 2014 the federal government announced that civil liability insurance would be required for motor vehicle owners who travel on federal roads, avenues and bridges in order to guarantee third parties relief for any damages caused to themselves and their property. This measure was gradually rolled out under the Law of Federal Roads, Bridges and Transportation and, as of 1 January 2019, now applies to all motor vehicles.
The Ministry of Finance and Public Credit recently published a resolution in the Official Gazette modifying the general regulations that apply to banks. The resolution responds to the need to strengthen the regulatory framework applicable to banks, particularly with regard to cybersecurity and technological infrastructure. It also aims to guarantee the confidentiality, integrity and availability of customer information.
The Energy Regulatory Commission recently confirmed that certain business models used by retailers of refined products (eg, diesel and gasoline) are valid and stimulate competition in the market to the benefit of customers. As such, retailers can develop loyalty programmes based on bonuses, credits, subscriptions, memberships or exclusive offers, among other things, to be offered by various petrol stations. However, these programmes must be made available to all customers and cannot be discriminatory.
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.
In his inaugural address, President Andrés Manuel López Obrador confirmed that fracking will be prohibited in Mexico. As Mexico is highly dependent on the natural gas potential of basins located in the northern part of the country, this prohibition will deny it access to resources which it needs to achieve energy sufficiency. Thus, both the executive and legislative branches should instead consider appropriate regulation (rather than a simple ban) that allows for the rational use of oil and gas resources.
Mexico recently became the first country to liberate the 600MHz band after the Federal Telecommunications Institute approved the relocation of the last two channels that transmitted therein in order to free it up for 5G broadband services. This transition will enable Mexico to make the band available to the market through a bidding process and exploit international mobile telecoms applications for 5G mobile broadband services.
President Andrés Manuel López Obrador recently confirmed that bidding rounds organised by the National Hydrocarbons Commission will be suspended for at least three years until the contracts awarded during the previous administration result in effective investment and, most importantly, new oil and gas production. The new president has further affirmed that production will be increased through additional investment in Pemex, which will ultimately result in the national oil company's rescue.
A member of the House of Representatives recently introduced a legislative proposal that seeks to amend the Organic Law of the Federal Public Administration. The proposed reform aims to grant the central government significantly more control over the public administration, including with regard to the energy sector. Essentially, the National Hydrocarbons Commission and the Energy Regulatory Commission will no longer be independent from a technical and operational standpoint.
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.
In 2017 the Federal Telecommunications Institute published the General Guidelines for the Accessibility of Broadcast Television Services, which will take effect in December 2018. The guidelines establish requirements regarding the inclusion of Mexican sign language or hidden subtitles in certain programmes, which apply to concessionaires that use a signal to commercially transmit broadcast TV to more than 50% of the Mexican territory and federal public entities that are concessionaires of public broadcast TV.
President Elect Andrés Manuel López Obrador has already published his environmental agenda, which sets out the objectives to be met and the strategies to be implemented during his six-year term. Under the agenda, a number of regulatory changes regarding air emissions, environmental impact assessments and coastal and marine zones will be introduced. In addition, Mexico will keep working towards its goals under the Paris Agreement and its administrative offices will undergo significant changes.
The 2013 energy reform significantly opened up the energy sector to private participation, thus ending the state's decades-long monopoly. However, the newly elected administration has pledged to revisit the reform and grant the state greater control of the sector. Although there have been mixed messages in this regard, the new administration has confirmed that the third bidding round for granting exploration and production licences and share production agreements will be suspended indefinitely.
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.