COVID-19 Legal and Tax Resource Center

(updated as of 8 April 2020)

As the COVID-19 pandemic continues to spread across the globe, disrupting lives, communities and businesses, and putting countries under considerable strain, NNDKP has set up the COVID-19 – Legal and Tax Resource Center. Here you can access valuable knowledge and legal insights with respect to the implications of the coronavirus in various fields in Romania.

Our lawyers and consultants are closely monitoring all COVID-19 developments to keep you up to date with the latest information, and to help you mitigate risks during this challenging time.

For any questions, your contacts at NNDKP are available either by e-mail or telephone. Updates related to the impact of COVID-19 will be included here regularly, as the situation evolves.

For further insights, also see our Legal and Tax Updates section.

We are ready and committed to assist you with valuable advice and practical considerations in order to address any challenges you may face and to help you move forward.


Moving Forward. Together.

The coronavirus disease (COVID-19) outbreak continues to put pressure on the public and private sectors alike.

Public officials/ institutions and authorities continue to identify and communicate measures aimed to limit the spread of the disease and to manage its effects, the latest being the declaration of the state of emergency in Romania as of 16 March 2020 for a period of 30 days.

The aim is to streamline and facilitate the swift allocation of resources, support the health system, implement solutions for prevention and limitation of the spread of the disease, diminish the negative impact on economy. Further, public authorities are expected to announce new measures as the situation evolves.

The private sector alike took actions to implement preventive measures while managing the impact, including in terms of changes necessary to be brought to their processes to comply with the measures imposed by public authorities.

NNDKP aims to assist organizations in this effort by sharing the insights developed in respect of the COVID-19 disease implications in various fields. Check regularly for updates.

Together we will find the most suitable solutions for moving forward!


  • BRIEFING – PRESIDENTIAL DECREE ON EMERGENCY STATE

    The decision to institute a state of emergency is based on the collective efforts of the national authorities to prevent the spreading of COVID-19 and the possibility to ensure that all necessary measures are being taken in such an exceptional situation.

    The decree sets forth various measures, out of which we outline the some of the most relevant ones for the private sector.


    A) Restriction of several fundamental rights

    • In order to enforce such measures a series of fundamental rights are proportionately limited, such as: a) freedom of movement; b) the right of respect for private and family life; c) inviolability of domicile; d) right to education; e) right of property; f) economic freedom;

    B) Measures impacting the economic sector

    • The Government may take measures to support economic operators from sectors affected by COVID-19;
    • In order to combat the spread of infections with COVID-19, public authorities may requisition production units of materials and equipment which are necessary in fighting this epidemic.
    • Beneficiaries of European funds which will be affected by the measures taken according to the hereof Decree may decide, according to the management authorities/ intermediary organisms, to suspend the financing contracts concluded according to the law.
    • Measures for insuring the continuity of supply, respectively: extraction, production, processing, transport, distribution, maintenance and repair of resources and raw and/or semi processed materials which are necessary for the proper functioning of the national energy system, as well as for the continuity of the system’s proper functioning and all of the public utility services.
    • “automatic extension” of documents issued by public authorities (e.g. licenses, permits) due to expire during the state of emergency;
    • During the time the state of emergency is in force the price of medicine, medical equipment, food of strict necessity and public utility services may be capped (e.g., electricity, thermal energy, water supply, sanitation, fuel etc.), within the limit of the average price of the last 3 months before the state of emergency was declared.

    C) Measures regarding employers

    • The Government may support the employers and employees affected by the effect of the COVID-19 crisis, by derogation from the legal provisions in force.
    • The local and central public authorities and institutions, autonomous administrative authorities, autonomous administrations, national companies and companies where the state holds 100% or the majority of the share capital and private companies shall introduce, where it is possible, during the state of emergency, work from home or a telework regime, by unilateral act of the employer.
    • During the state of emergency inspections from the Territorial Labor Inspectorates are suspended, with the exception of inspections imposed by the Minister of Employment and social protection, of those imposed by the Employment Inspection as regards transposing the Decisions of the National Committee for Special Emergency Situations, of those necessary to investigate complaints of deeds with high degree of social danger and for researching labor accidents.

    D) Measures related to the justice system

    • The statutes of limitation (in Romanian termen de prescriptie) and any other time limits (in Romanian termen de decadere) do not start to elapse and, if they started to elapse, they are suspended for the entire duration of the emergency state is enforced according to the hereof Decree, as the provisions of art. 2532 pct. 9 second thesis of the Civil Code or other contrary legal provisions, do not apply.
    • During the emergency state, the activity of the courts of law continues only in the trials of utmost emergency. A list of such cases shall be established by the Management Board of the High Court of Cassation and Justice for cases pertaining to the latter and by the Management Boards of the Courts of Appeal for cases pertaining to their jurisdiction and other courts in their jurisdiction.

    E) Other measures

    • Public institutions and authorities as well as private operators shall contribute to the public information campaign regarding the measures adopted and the activities performed nationally.
    • In case fake information will be spread by mass-media or online with regard to COVID-19 and the prevention and protection measures, the public authorities and institutions shall take the necessary measure to insure that the population is correctly and objectively informed in this context.
    • Hosting service providers and content providers may are obliged that, in case of a motivated decision of the National Authority for Administration and Regulation in Communications in this regard, to immediately suspend the transmission through an electronic communication network or content storage of fake news regarding COVID -19 or the prevention and protection measures, by eliminating the content at the source, while also informing the users about the fake content.
    • Endowment and consumption rules provided in the enforce legislation may be exceeded if such is due to the effects of the evolution of COVID-19 and the protection and prevention measures.
    • The legal terms established for answering requests made in the exercise of the free access to information of public interest, as well as the right to petition are doubled.

    F) Measures with immediate application, in gradual manner

    • Isolation and quarantine of persons from risk areas, as well as those who come into contact with them; quarantine measures on certain buildings, localities or geographical areas;
    • Gradual closing of crossing points of the state border;
    • Limitation or prohibition on the movement of vehicles or persons in / to certain areas or between certain areas, between certain hours, as well as leaving the respective areas;
    • Gradual prohibition of road, rail, maritime, river or air traffic on different routes and subway transportation;
    • Temporary shutdown of restaurants, hotels, cafes, clubs, casinos, headquarters of associations and others public places;
    • Ensuring the security and institutional protection of water, energy, gas supply stations, and of economic operators that have facilities of strategic importance at a national level;
    • Identification and requisitioning of stocks, production and distribution facilities, protective equipment, disinfectants and medicines used / usable in the treatment of COVID-19.

    Check regularly for updated on adopted restrictions.

  • APPROACHES

    Operational matters

    It is recommendable to establish an internal task force that will be in charge of:

    • create a COVID – 19 Task Force to manage in a centralised manner continuous developments of the situation and stay informed on all updates and developments of the COVID-19 outbreak
    • set your own procedures and policies for addressing the COVID – 19 circumstances that impacted your organisation, stakeholders & employees, as well as business relationships; coordinate the update thereof at the level of COVID – 19 Task Force
    • establishing contact persons at the level of the Task Force and a communication processes for stakeholders & employees, authorities, as well as external partners by categories of activities; centralize & keep track of information
    • prepare a contingency plans and projections, take into account both circumstances that may affect your organisation as well as the ones affecting your business partners
    • liaise with external partners, as well as relevant consultants in order to timely process & assess information and regulations that are in a continuous change in order to enable your organization to swiftly respond to the measures enacted during the state of emergency

    Ongoing agreements

    As the COVID-19 pandemic is affecting all lines of business it is more and more relevant for each company to analyse its commercial relationships and exposures. As “disruption” is no longer a question of if, but when, each company should assess how to respond to the disturbances ahead. In these circumstances an increased attention should be given to the existing agreements, as well as to ongoing negotiations.

    TO DO LIST

    • inventory of contractual relationships and prioritise depending on expected impact in terms of expected extent and timeline thereof
    • analyse your contracts – identify all terms and conditions that may be relevant, for example failure to fulfil the obligations & mitigation mechanism, changing circumstances, force majeure
    • initiate discussions with commercial partners and keep track of discussions and correspondence; changes to contracts have to be implemented following appropriate procedure
    • seek advice in agreeing new terms in order to avoid endanger further position

    CONTRACTUAL MECHANISMS THAT MAY BE RELEVANT

    • Invoke Force majeure – Force majeure is any external, unforeseeable, absolutely invincible and unavoidable event. Parties are exonerated of their obligations as a result of force majeure. Force majeure can be invoked even in agreements in which the parties did not insert an express force majeure clause.
      • However, parties are not exonerated from the performance of their obligations which were due when the force majeure event occurred.
      • Applicability of force majeure is not automatic due to COVID -19 pandemic, an analysis of circumstances of each agreement is important to assess whether the legal and/or contractual conditions for invoking the force majeure are met.
      • The party claiming force majeure must prove that the impossibility to perform its contractual obligations was determined by the force majeure event. In some cases, the party claiming that force majeure has occurred must obtain a document attesting the force majeure event- such as the force majeure certificate issued by the Chamber of Commerce.
    • Hardship – if the performance of the agreement becomes excessively onerous for one of the parties, a hardship claim may be also considered. Hardship is conditional upon fulfillment of the following conditions : (i) a change in the contractual circumstances underlying the execution of the contract occurred after signing; (ii) the change of the contractual circumstances were not, and could not have been, easily foreseen at signing; (iii) the party claiming hardship has not assumed the risk of a change of the circumstances underlying the contract, nor can it be reasonably considered to have accepted this risk; and (iv) the party claiming hardship reasonably and in good faith attempted a fair and reasonable revision of the agreement. Nevertheless, if the parties do not agree to renegotiate or do not reach an agreement a claim must be raised before court.
    • Non-performance defense – in case contractual parties are in the position of not being capable to execute their obligation the non-performance defense may be raised. However, a party may not invoke such defense if the non-performance is caused by its own action or omission.
    • Other contractual mechanisms that may be relevant include: procedure to be followed in case of breach of the agreement or for amendment thereof, general terms and conditions, applicable law & jurisprudence. All procedures must be followed accordingly in order to preserve existing rights, so irrespective of discussions and correspondence don’t forget to notify according to agreed procedure and properly amend relevant agreements once an agreement is reached.

    Your Contacts:

  • EMPLOYMENT – Q&A

    Romanian and English versions available. Click here to download.

    Below you may find answers to the most relevant employment questions in the COVID-19 disease context:

    Are employees obliged to disclose themselves as „risk-factor” to the employer? Normally yes, as they are required under the health and safety at work legislation to immediately notify the employer regarding any work situation about which they have reasonable grounds to believe is a danger for employees’ health and safety. Such notification would also be warranted in consideration of the employees’ general obligation of loyalty and good faith towards the employer.
    Can the employer demand employees to disclose themselves as being a „risk-factor”? Yes, since the employer has the obligation to inform competent authorities in case of any COVID-19 cases in the workplace.

    Employees should notify the local public health authority, call a dedicated number (0800.800.358) or, if none of the above options are successful, call the emergency number 112.

    Can the employer issue an instruction (or a policy) requiring employees to report co-workers with flu symptoms (i.e. fever, cough, difficulty breathing, pain in the muscles, tiredness) to the employer? It is not recommended to do so, but rather to put in place some general instructions whereby to encourage the employees to act responsibly in the COVID-19 context, including by disclosing any risk concerns or stay at home in case they have flu like symptoms.
    Can the employer require an employee to see a doctor? No, but the employer can recommend an employee to see a doctor.

    However, the occupational doctor can send the employee to perform additional medical checks while at work place.

    Does the employer have the obligation to report infections occurring in the business to health authorities? The employer has to inform the competent authorities in case there are COVID-19 cases at the workplace.
    What happens with employment contracts in case of quarantine or force majeure? The employment contracts of the employees are suspended by law. Consequently, employers are not required to pay the employees their salaries during this period of time. We recommend to monitor any legislative developments in this area.
    Are the employees entitled to any kind of medical leave and related pay? Employees effectively infected with the COVID-19 virus are entitled to regular medical leave. These employees are entitled to receive 75% of their regular pay based on the current legislation. This amount may increase to 100% if COVID-19 will be added by the state on the list of severe diseases. We recommend monitoring legislative developments in this area.

    Employees placed in quarantine or self-isolation by the state are entitled to a specific medical leave. These employees are entitled to receive 75% of their regular pay during this period.

    Can employees refuse to come to work? Can employees refuse to attend meetings or to travel? In principle, no – the employees should continue to observe their job descriptions and fulfil their job duties so as to ensure business continuity.

    Employees can refuse to come to work when their health is under a significant risk (i.e., risk of infection and no remedy measures were taken by the employer). Hence, it is important not only to adopt, but also communicate to employees the preventive measures taken to protect employees’ health.

    Is the employer required to pay the salaries if employees refuse to come to work? If employees refuse to come to work and the parties cannot reach an agreement on a flexible working regime, the employer may suspend the employment due to ungrounded absences from work. In this case, the employer would not have to pay the salary rights as of the date of the suspension decision.
    Can the employer send employees to work from home, even without their consent? Yes, the employer may send the employees to work from home based on Article 48 from the Labor Code – which allows employers to unilaterally and temporarily change the place of work of their employees as a result of a force majeure or as a measure to protect the employees.
    Can the employer suspend employment contracts and send employees home? The employment contract is suspended by law when the employee enters into quarantine (when such is imposed by state, in accordance with the law), in case of force majeure or when the employee is in medical leave (as it may be the case regarding a quarantine/self-isolation period).

    Currently, quarantine or self-isolation are ordered, for example, if an individual is returning from a red/yellow-labelled country (i.e., with extensive transmission of COVID-19) or if it was in direct contact with a person diagnosed with COVID-19.

    If the employment contracts are suspended, do the employers still need to pay salaries? If the individual employment contract is suspended, the employee is not required to perform the activity and the employer is not required to pay the salary rights.

    If employers suspend the activity by their own initiative in case of temporary decrease of their activity, employers have to pay employees 75% of their base salaries.

    When is the employer forced to shut down its operations? Only if this measure is adopted as part of the state of emergency package, now that this state of emergency was formally approved on 16 March 2020. We recommend constantly monitoring legislative developments in this area.
    If kindergartens and schools are closed and employees need to stay home and cannot work, does the employer need to pay them and – if so – for how long? Under Law 19/2020, if kindergartens and schools are closed as a result of an official decision issued by the competent authorities, parents with children up to the age of 12 (or of disabled children up to the age of 18) are entitled to paid days off, but only in cases where the jobs occupied are not compatible with work from home or with telework. The allowance is of 75% of the salary for one day of work and is capped at the corresponding value for a day of 75% of the average gross wage (i.e. RON 5,429).

    In specific sectors (e.g. in gases & electricity fields, continuous work units) the above rule applies only if also agreed upon by the employer.

    The provisions related to paid days off are not applicable to (among others):

    • persons whose labour relations (or the labour relations of the spouse) are suspended due to the temporary interruption of the employer’s activity (technical unemployment);
    • if one of the parent is on child raising leave or childcare leave for the sick child, on holiday or unpaid leave.

    Also note that this benefit is not applicable for the periods of school holidays.

    Which employers can benefit of technical unemployment aid from state? In case of employers that suspend the individual employment agreements for technical unemployment, the allowances granted to the affected employees (which are established at 75% of the base salary corresponding to the position held) are borne from the unemployment insurance state budget, but no more that 75% of the average gross salary (which is now of RON 5.429, resulting in a maximum of RON 4.071,75 borne by the state).

    Even though the unemployment allowance would have normally been of minimum 75% of the salary of the employee, employers who apply for this state-covered indemnity will not be obliged to cover the difference between the cap of RON 4.071,75 (covered by the state) and the 75% of the employee’s salary, if any. The indemnity paid by the state may be supplemented by employers to minimum 75% of the employee’s salary, but only if their budget can afford this.

    This benefit (of having the unemployment allowance paid by the state) has been recently extended to all employees of the employers that have their activity reduced or interrupted temporarily, totally or partially, following the effects of COVID-19 epidemic. There will be no need for a specific certificate issued by the Ministry of Economy, Energy and Business Environment, nor to have a specific object of activity or to have a specific decrease in the income.

    The employers will just have to send certain documents via e-mail to the employment agencies (i.e. a request, an affidavit and a list of impacted employees).


    General key actions for employers

    • keeping the employees up to date with the developments of the situation and reminding them constantly about recommendations that would mitigate the risk of infection and indicating person(s) within the company that could work as contacts for providing them specific information/support on the matter;
    • ensuring that the office premises have disinfection items available for the employees and that premises are constantly and properly cleaned;
    • limit any unnecessary interactions (e.g. attending face-to-face meetings, conferences, events etc.) and the business travels;
    • asking the employees to promptly inform their managers/HR about their past travel into affected regions, about potential quarantine/self-isolation measures imposed by the authorities with respect to them;
    • reminding the employees to contact the doctor as soon as they have any symptoms.
    • close relationship with the health and safety provider, as well as with the work medicine physicians (occupational doctors).

    Your Contacts:

  • GDPR – Q&A

    Below you may find answers to some of the most relevant GDPR-related questions in the COVID-19 disease context:

    Can a company use questionnaires asking certain information from employees or visitors prior to allowing them to access its premises? Yes, but such questions should normally be limited to:

    • whether the individual has been in the last 14 days in COVID-19 quarantined areas;
    • whether he is subject to an active quarantine or self-isolation measure (without asking for the reason); or
    • whether he believes to have been in contact with persons confirmed or suspected of having the COVID-19 disease (without asking for details/name of the respective person).

    Asking if the individual has certain symptoms (e.g., fever, shortness of breath) is not advisable, as such details qualify as sensitive data. Under GDPR, the processing of such data is allowed only in limited cases. In the COVID-19 disease context, one justification may be when the law requires companies to collect the data (but this is not usually the case) or when companies may reasonable demonstrate that they need to undertake the processing for reasons of public interest in the area of public health, such as protecting against cross-border threats to health. But this does not justify preventive collection of health data from all employees or visitors.

    However, questionnaires may include the recommendation to follow general public health advice on managing COVID-19 risks.

    How much time can a company retain the visitors or employees’ questionnaires? No legal term exists, so each company has to decide its own retention period. It is recommendable to set short periods (e.g., 30 to 60 days) with the possibility of prolongation as required (e.g., if the authorities ask for the data as part of an epidemiological investigation).
    What other measures should companies take for using visitors’ questionnaires?
    • restrict the access to questionnaires (ideally to 1 or 2 persons within the organization, e.g.: health doctor)
    • define the applicable technical and organizational rules for protecting the confidentiality of questionnaires;
    • appoint persons responsible to monitor compliance with the relevant retention terms, access rights, etc.
    Has the Romanian data protection authority (DPA) issued any guidance in the context of COVID-19 disease? Yes, on 18 March 2020 the National Authority for the Supervision of Personal Data Processing has issued clarifications on the conditions to be met in case of processing health data in the COVID-19 context. The clarifications are available here. Pursuant to such clarifications, there are several guarantees already recognized by GDPR that, if applicable, allow the processing of health data. These are:

    • meeting legal obligations towards employees – including on health and safety at the work place
    • processing as part of activities related to preventive medicine, including diagnosis and provision of medical assistance, etc. – this is most relevant for the companies in the medical sector, including providers of occupational medical services
    • reasons of public interest in the area of public health, such as protecting against cross-border threats to health – this may be relevant for companies from all sectors, but should be invoked with care
    • individuals’ consent
    Can employers ask employees to report if they have been diagnosed with COVID-19 disease? Yes, especially since this diagnosis triggers obligations under employment law (e.g., medical leave) and public health legislation (e.g., to disinfect premises).
    Does the company provide a privacy notice to the employees about the processing of sensitive data (i.e., that the employees have been diagnosted with COVID-19 disease)? No, as long as the already provided privacy notice covers the processing of health data for complying with legal obligations.

    If, however, the company opts to share the health data with other third parties than public authorities based on reasons of public interest in the area of public health, such as protecting against cross-border threats to health, this may trigger the need to provide an additional notice to employees, unless this possibility was already covered in the general employee privacy notice (this was not necessarily industry practice until now).

    Based on the DPA guidance, companies may provide this via the website. In employees’ case, alternative communication tools may by the email or the Intranet (the latter, if the employees continue to have access to this tool even if they work from home). 

    Can the company disclose the information that employees were diagnosed with COVID-19 disease to third parties? To public authorities: Yes, companies can communicate the date to the local public health authority or the emergency services (112) (if the company cannot reach the public health authority in due time to the increase in demands experienced by the authority).

    To other employees: Normally no, unless this is necessary in order to determine if other employees are at risk due to contact with the employee.

    To other companies within the group: Normally no, unless this is necessary for reasons of public interest in the area of public health, e.g. as protecting against cross-border threats to health. For example, the company may wish to disclose the information if the affected employees have been traveling to the employer’s affiliate in another country during the incubation period. The company should:

    • assess these situations on a case by case basis, including to check that there are no (additional) limitations within the legislation applicable to the affiliate;
    • document such assessment, including why the company deems that the disclosure is necessary for reasons of public interest in the area of public health, such as protecting against cross-border threats to health;
    • ideally limit the sharing from health and safety at work responsible to health and safety at work responsible within the two affiliates.

    To other third parties: Normally no, the only information to be provided, if necessary, should be that the employee is on leave (i.e., not on medical leave). Based on DPA guidance, disclosure of an infected employee’s personal data to the public can be done only with the individual’s consent.

    However, anonymised information e.g. that a positive case or contact case was confirmed can be shared on reasonable need to know bases (e.g. to companies within the same office building as the employer), always mindful to spreading information that may create panic.

    Can the National Authority for the Supervision of Personal Data Processing (DPA) still perform investigations during the period? Yes, since the DPA can exercise its investigative powers from their own headquarters. The DPA has used such possibility often in the past, hence there is no reason to believe their remote investigation activities will be significantly diminished.

    If the company diverted resources normally tasked with managing DPA investigations to address COVID-19 actions, we believe the DPA will accept grounded requests to extend deadlines for responding to DPA’s requests of information and documents.

    Is the company still required to comply with deadlines for managing data subject requests? Yes, the general 30-day term for responding to requests still applies.

    If the company diverted resources normally tasked with managing data subject requests to address COVID-19 actions, the company can notify the data subject about the extension of the response deadline for up to two (2) months and the grounds for such extension. The company needs to send this notification within the initial 30-day deadline.

    Is the company still required to notify data breaches within 72 hours as of becoming aware of them? Yes.

    If the company diverted resources normally tasked with managing (including notifying) data breaches to address COVID-19 actions, the company may notify the data breach in phases, explaining the reason why not all details are readily available within the initial 72-hour deadline.

    If the company notifies the data breach with delay, it may explain the reasons for such delay, but it will be up to the DPA to assess and decide if such grounds suffice to justify the submission with delay.

    How is the DPA’s activity impacted during this period? For now, the DPA has suspended all audiences at its headquarters. Audiences with the interested public can be organized by phone from 9:00 to 12:00 every day. It also reduced the working hours of its registration office as follows: Monday, Wednesday and Friday, from 9:00 to 11:00 am.

    Your Contact:

  • COMPETITION – Q&A

    Romanian and English versions available. Click here to download.

    Below you may find answers to some of the most relevant competition law questions in the COVID-19 pandemic context:

    Does competition law still apply? Do companies still need to observe competition rules in this context? Yes, competition law continues to apply, and companies still need to observe competition rules in their activity, including in the pandemic context.

    While context will be relevant in the analysis, companies’ measures addressing the effects on them and consumers will be scrutinized under competition rules.

    For example, the Romanian Competition Council announced it is closely monitoring the companies conduct, seeking to ensure that this public health emergency will not lead the companies to:

    • raise prices without objective justification
    • exchange sensitive information
    • engage in exclusionary practices
    • abuse their dominant positionengage in anti-competitive agreements (in order to fix prices, share customers and territories or limit sales).

    Neither the efforts to manage an investigation nor the risk of companies’ image being affected by the suspicion of anticompetitive behaviour in these circumstances can be neglected, even if in some cases the Competition Council might in the end reach the conclusion that a conduct addressing the current situation is competition law compliant.

    What happens if a company increases prices in the context of high demand of certain products it sells in this period? Risks in case of price increases in this period may arise for both dominant and non-dominant companies (dominance being presumed at market shares exceeding 40%).

    The Competition Council will scrutinize price increases by dominant companies in order not to be excessive.

    Imposing the additional purchase of non-essential products when buying high demand products, refusing to deal with certain customers or offering discounts can also be analysed in order not to be abusive.

    Some companies may be found to have higher market power than known before due to markets being defined more narrowly, especially when getting harder for customers to buy from alternative suppliers.

    Non-dominant companies’ price increases may be scrutinized if there are any suspicions of collusion/ decisions not taken independently. Even in case of independent conduct of non-dominant companies, restrictions may arise (authorities’ measures/ consumer protection considerations).

    Companies should ensure that the prices they charge are reasonable and justified.

    Current enforcement activity

    The Romanian Competition Council announced it has recently launched an investigation into price increases for protective face masks.

    Can administrators of online marketplaces take measures with regard to economic operators which sell their products at unreasonably high prices on the respective platform? As the Competition Council also announced, in the current context, administrators of online marketplaces may impose measures to limit unjustified price increases for basic products and services. The extent of the measure should however be carefully checked in advance.

    At international level, several online platforms have already taken measures in this regard, banning sales of certain products (Facebook banned ads and commerce listings selling medical face masks) and de-listing sellers (Amazon removed thousands of listings).

    Can competitors cooperate in order to respond more effectively to the current situation? UPDATE 23 March: The European Competition Network (ECN, network of competition authorities) issued a joint statement: ECN understands that this extraordinary situation may trigger the need for companies to cooperate in order to ensure the supply and fair distribution of scarce products to all consumers. ECN will not actively intervene against necessary and temporary measures put in place in order to avoid a shortage of supply (these measures are unlikely to be problematic – either they would not amount to a restriction of competition or the efficiencies would outweigh any such restriction).

    At the same time, the ECN will not hesitate to take action against companies taking advantage of the current situation by cartelising or abusing their dominant position.

    In line with this joint statement, the Competition Council publicly announced that during this crisis:

    • Companies can coordinate in order to limit the deficit of essential products and ensure a balanced distribution – for example, retailers can coordinate transport to ensure the supply of products/ home delivery for people not able to leave their homes;
    • Companies must insure that prices are available at competitive prices: owners of online platforms may impose measures to limit the unjustified increase of prices for basic products and services; producers can set a maximum price, which might be useful to limit unjustified price increases at distribution level.
    • The Competition Council will take measures against companies that engage in abusive practices (such as setting excessive prices) or cartel type practices.

    Therefore, any practice that is not justified by the current context will continue to be sanctioned – it is recommended for companies to check with the authority the measures they intend to put in place.

    INITIAL COMMENT (continuing to be relevant in terms of principles of analysis): As the Competition Council also announced, in the current context, companies are allowed to take measures justified by prevention and by the need to address supply and distribution chains challenges. At the same time, they should be careful that these measures do not entail serious competition restrictions – “crisis cartels” will continue to be prohibited.

    This period could see more examples of joint logistics and distribution by food, medicines or medical equipment suppliers, or coordination of responses to market conditions by travel and accommodation providers (in light of cancellation/ reimbursement instances).

    Key aspects to be carefully taken into account, since such initiatives may be justified, but may also entail high competition risks if for example:

    • sharing competitively sensitive information (e.g., current or future prices, costs, output);
    • using the discussions as an opportunity to set prices, restrict output, divide customers or markets, or coordinate commercial strategies.

    Possible actions companies can take in order to mitigate competition risks in relation to information exchanges with competitors in this period:

    • identify legitimate goals for the information exchange that are pro-competitive or competitively neutral;
    • ensure communications do not go beyond the legitimate goal of the initiative and are limited to what is reasonably necessary;
    • ensure that discussions on best practices (e.g., in relation to remote working) do not turn into agreeing decisions which should be taken independently;

    any discussions with competitors should follow a structure prepared and reviewed in advance.

    Can industry associations take/ encourage decisions for all members? Industry association efforts, including in discussing with authorities in relation to initiatives and responses to the crisis situation, are even more important in this period.

    However, the same essential principle applies: discussions in associations should not result in decisions taken by/for their members on sensitive topics which should have been reached individually.

    Are joint research activities allowed? In order to address the present public health emergency, pharmaceutical companies/ medical suppliers/ other companies will seek to join efforts to accelerate the search for solutions (e.g., finding appropriate treatments for COVID-19).

    While these efforts are encouraged and supported, when carried out jointly, they should remain within the scope of the response to the public health emergency and not serve as a tool to engage in exchange of competitively sensitive information, or evolve into a cartel (otherwise prohibited price fixing, output limitation or market allocation).

    R&D cooperation should also not prevent companies from innovating, if they could do this more efficiently on their own.

    What if cooperation leads to creation of companies/ changes to existing ones? Where cooperation leads to the creation of new corporate structures (e.g., joint ventures) or changes to existing ones, merger filings may be required, depending on the characteristics of the new entity, and transactions cannot be implemented prior to clearance or derogation from the Competition Council.
    Examples in other countries – key enforcement topics
    • United Kingdom decided to relax elements of the Competition Act 1998 as part of a package of measures allowing supermarkets to work during this crisis:

    Thus, retailers can (i) share data with each other on stock levels, (ii) cooperate to keep shops open, (iii) share distribution depots and delivery vans, (iv) pool staff with one another to help meet demand.

    Where agreements are not covered by that legal relaxation, the CMA publicly announced that it has no intention of taking competition law enforcement action against cooperation between businesses or rationing of products to the extent that this is necessary to protect consumers (e.g. by ensuring security of supplies).

    The CMA also mentioned that businesses exploiting the crisis as a ‘cover’ for non-essential collusion will be sanctioned (e.g. exchanging information on longer-term pricing or business strategies, where this is not necessary to meet the needs of the current situation).

    • the Government in Norway has granted a temporary exemption for the transport industry, allowing airline companies to cooperate (routes coordination) for at least three months
    • the UK’s Competition and Markets Authority announced that it would take action against violations of consumer protection and competition laws, such as excessive pricing and misleading advertising;
    • Italy’s competition authority is seeking information on how online platforms are preventing unjustified price spikes and false claims regarding the efficacy of products;
    • The Polish competition authority has opened investigations into wholesalers which allegedly terminated contracts with hospitals to sell protective equipment on the market for disproportionately high prices;
    • In the United States, the Federal Trade Commission and the Food and Drug Administration have jointly issued warnings to several companies alleged to be making unauthorized claims about the efficacy of certain products for preventing or treating COVID-19;
    • Korea’s Fair Trade Commission raided pharmaceutical companies and consumer-goods sellers on suspicions that they bundled face masks with other products;
    • China’s State Administration for Market Regulation fined a store in Beijing $434,530 for hiking the price of face masks up by more than six times the online rate.

    Your Contact:

  • STATE AID – Q&A

    Romanian and English versions available. Click here to download.

    Below you may find answers to some of the most relevant state aid law questions in the COVID-19 pandemic context:

    Which are the main state aid measures envisaged by the Romanian Government in order to compensate the economic impact of COVID-19 crisis? It is expected that the Romanian Government will issue state aid measures in order to support companies affected by the COVID-19 crisis.

    In addition to other measures, the Romanian Government announced that it will provide state aid in the form of guarantees for loans for small and medium-sized enterprises (SMEs) with subsidized interest.

    For instance, under this scheme, companies can receive loans of up to 10 million RON if they use the money for investments or up to 5 million RON if they use the money for working capital. In this scenario, 80% of the loan will be guaranteed by the state.

    More details on the terms of these state aid measures to follow once the official legislative act will be available.

    How did the European Commission react to the COVID-19 rapid expansion within the European Union? In relation to state aid matters, the European Commission had a positive reaction both in terms of providing concrete solutions as well as in terms of approval of new state aid measures.

    The European Commission prepared a draft proposal for a State Aid Temporary Framework to support the economy in the context of the COVID-19 outbreak.

    The Temporary Framework will enable four types of aid:

    • direct grants and selective tax advantages;
    • State guarantees for loans taken by companies from banks;
    • subsidized public loans to companies;
    • safeguards for banks that channel support to the real economy;

    On top of that, European Commission is very responsive to any requests coming from the Member States succeeding to approve within 24 hours from its formal notification the first coronavirus related state aid measure.

    Examples in other countries – key state aid measures
    • Denmark obtained the Commission’s approval for a €12 million State aid scheme aimed to compensate event organizers for losses caused by the cancellations of large events due to the COVID-19 outbreak.
    • France’s government announced that it will grant €345 billion to support the economy and to prevent the risk of bankruptcy – €45 billion as direct aids and €300 billion as guarantees for securing companies’ bank loans.
    • Germany’s government announced an expansion of the scope of KfW financing programs, as well as the possibility to access federal and state guaranteed loans.
    • Norway took measures to support the aviation industry, by suspending all airport fees for the first six months of 2020, as well as the taxes charged for each passenger for a period of 10 months.
    • The United Kingdom’s government announced granting a £330 billion package of government-backed and guaranteed loans aimed at supporting businesses affected by the COVID-19 pandemic.
    Are there any COVID-19 implications on State aid already granted? The unexpected outbreak of the COVID-19 will very likely have a considerable impact on many State aid measures granted to companies operating in various sectors. The raising uncertainties at an economic level, both national and international, are capable of affecting the process of starting, implementing and maintaining the investments.

    Two major State aid schemes (approved by the Government Decision no. 807/ 2014 and Government Decision no. 332/2014) are currently in force in Romania and may be impacted by future measures to be undertaken by the Ministry of Public Finances

    Below you may find answers to some of the most relevant State aid law questions for State aids already granted/ currently being granted in the COVID-19 pandemic context.

    How can State aid beneficiaries be affected by COVID-19 pandemic context? In brief, State aid beneficiaries can be affected both in the implementation and in the monitoring phase, since COVID-19 pandemic may affect their ability:

    • to fulfill the obligation to start the investment within the deadline undertaken and/ or to finalize the investment according to the timing undertaken;
    • to maintain the initial investment in operation for a certain period of time after the completion (usually for 5 years);
    • to pay the contributions to the state budget;
    • to create the minimum number of jobs, as well as to maintain the newly created jobs;
    • not to relocate employees, as State aid beneficiaries may be forced to reduce their volume of activity in certain areas and, thus, some employees might need to be relocated to other areas, including in the factories where state aid was granted;
    • to meet the economic and financial results/ indicators undertaken through the financing agreement in terms of turnover, exports etc.
    In this context, will it be possible to extend the implementation/ monitoring period of the projects benefitting of state aid? What is the impact on EU funds? In terms of EU funds, the Presidential Decree on Emergency State contains a provision stating that beneficiaries of European funds which will be affected by the measures taken according to the Decree may decide, together with the managing authorities/ intermediary organisms, to suspend the financing contracts concluded according to the law.

    For each EU Financing Programme, the management authorities have already taken specific steps, in line with the Ministry of EU Funds instruction.

    The Ministry of EU Funds announced the following main measures for ensuring continuity:

    • tools for the electronic and telephone audiences were made available, as well as the HelpDesk application, which allows now for the provision of a response within a maximum of 36 hours;
    • specific instructions for the beneficiaries of the Operational Programmes to be communicated by each management authority in charge of a specific Operational Programme;
    • public consultations for establishing the financing priorities for the next period (2021-2027) announced and started will continue, depending on the availability of the participants.

    Main specific measures taken by the Management Authority for Large Infrastructure Operational Programme:

    • the beneficiaries have the possibility to extend the project deadlines (the progress reports that were previously submitted on a monthly basis will be submitted quarterly and the monitoring sheets will be updated quarterly and will be sent by e-mail, on the first working day of each quarter);
    • beneficiaries whose projects must be implemented by September 30, 2020 can submit a request for the amendment of the financing agreement, together with the amendment of the schedule of activities, within 10 working days.

    Main specific measures taken by the Management Authority for the Technical Assistance Operational Programme:

    • the authority will postpone meetings with beneficiaries, audiences, as well as on-site visits and will maintain contact with beneficiaries using the distance communication means;
    • the project activities that cannot be implemented during this period using distance communication means will be postponed by mutual agreement of the managing authority and of and the beneficiary;
    • as regards the projects whose implementation period will end within the next three months and for which it is not possible to reach the indicators undertaken, the managing authority will initiate amendments to the financing agreement in order to extend the implementation period. If this cannot be done in the context of the spread of the COVID-19, the financing contracts will be suspended by mutual agreement until the national emergency state ceases.

    Main specific measures taken by the Management Authority for Human Capital Operational Programme:

    • Instructions were adopted providing the framework, terms and conditions under which the beneficiaries may adjust their project according to the national emergency state (the decision regarding the continuation of the implementation during the state of emergency or the suspension of the implementation belongs to the beneficiary).

    However, until now there are no official statements in relation to the two major state aid schemes (Government Decision no. 807/ 2014 and Government Decision no. 332/2014).

    The answer on the concrete impact for each beneficiary of State aid will depend on each company’s specific situation, however, the extension of the implementation/ monitoring period for the two major State aid schemes will be an appropriate measure in view of the circumstances.

    Will the state aid beneficiaries be able to cumulate the pre-existing state aid with other state aid that will potentially be available in order to mitigate the damages caused by the COVID-19 outbreak? As a rule, the cumulation of different state aid measures is possible as long as they concern different identifiable eligible costs or if, in relation to the same eligible costs, the cumulation does not exceed the maximum level of the state aid provided by the State aid scheme.

    Some public support measures may not even fall under State aid rules since they represent measures available to all companies (no selectivity) such as wage subsidiaries or suspension of payment of contributions.

    For example, the support relating to technical unemployment will be deemed a general measure, applicable to all companies meeting certain conditions, thus not amounting to State aid.

    However, taking into account the consequences of breaches of State aid regulations, it is advisable to require specialized State aid advice on this matter.

    Will the rules regarding the submission of progress reports/ audited report certifying that the investment was carried out within the undertaken parameters be made more flexible? Considering the current circumstances and disruptions in many economic sectors, it is likely that the deadlines for the submission of reports, as well as other deadlines provided for in the State aid schemes, will be extended/ adapted in a reasonable manner, similar to the measures taken in relation to the EU funds.

    Should the company be in the position of submitting a report during this period, it is advisable, until any official position on the topic, to contact the managing authority in order to be granted with an extension.

    Will it be possible to submit all the relevant documents online and communicate with the representatives of the competent authority by audio or video conferences? Most probably, the management authorities will organize their activity in such a way as to reduce or even eliminate completely the necessity of the physical presence of the interested persons at their offices (e.g., it is possible that they will make online audiences and consultations available, like the Ministry of EU Funds already did).
    What can the beneficiaries of State aid do? State aid beneficiaries, as well as EU funds beneficiaries, can:

    • contact the  State aid/ EU funds managing authorities in order to get clear guidance;
    • monitor the websites of the Ministry of Finance/ Ministry of EU Funds for any announcements;
    • monitor the developments regarding the obtaining of the Certificate for emergency situations issued by the Ministry of Economy, Energy and the Business Environment.

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  • TAX

    Romanian and English versions available. Click here to download.

    As per Emergency Ordinance 29/2020 regarding certain fiscal-budgetary measures, published in the Official Gazette 230/2020, the following normative acts are amended and completed in order to combat the economic effects of COVID-19:

    I. Law no. 207/2015 regarding the Fiscal Procedure Code

    • Tax obligations due starting with the date of coming into force of the Emergency Ordinance for the duration of the state of emergency, and unsettled until 30 days after the state of emergency ends, will not be considered outstanding tax obligations and no late payment interest and penalties will be calculated and owed in this respect.
    • The measures for forced execution by seizure of individuals with the exception of the enforced executions that are applied for the recovery of the budgetary debts established by judicial decisions pronounced in criminal matters are suspended or will not start, from de date of the Emergency Ordinance’s entry into force until 30 days after the date of termination of the state of emergency.

    II. Law no. 227/2015 regarding the Fiscal Code

    • Taxpayers applying the annual payment and reporting system for corporate income tax, with quarterly prepayments, can make quarterly advance payments for 2020 at the amount resulting from current quarterly corporate income tax calculation.
    • The calculation method is maintained for all quarters of fiscal year 2020. The same principle applies also for taxpayers with a modified fiscal year.
    • This year’s (2020) first payment deadline for the building tax, the land tax, and the transport means tax is extended from March 31, 2020 to June 30, 2020 with the deadlines regarding the bonus for full payment also being extended accordingly.

    III. Ordinance no. 6/2019 regarding the establishment of certain fiscal facilities

    • The deadline for submitting the notification regarding the restructuring intention is extended until July 31, 2020;
    • The deadline for submitting the restructuring request is extended until October 3o, 2020.

    IV. Emergency Ordinance no. 110/2017 regarding the program for the restoration of small and medium-sized enterprises

    • The maximum value of the financing guaranteed by the state is increased to 10,000,000 lei and will be granted for one or more credits for investments and / or one or more credits for working capital.

    V. Law no. 69/2010 regarding fiscal-budgetary responsibility

    • During the state of emergency, the main loan officers are authorized to perform budgetary credits transfers for the application of measures to combat and prevent the spread of the SAR-COV-2 virus that causes the COVID-19 infection.

    VI. Small and medium-sized enterprises

    • During the state of emergency, the small and medium-sized enterprises holding the emergency situation certificate, issued by the Ministry of Economy, Energy and Business Environment, benefit from the deferred payment for utilities – electricity, natural gas, water, telephone and internet services as well as deferral of payment of the rent for the building for social headquarters and secondary offices.

    VII. Law no. 129/2019 for the prevention and combating of money laundering and terrorist financing, as well as for the amendment and completion of  certain normative acts

    • The deadline for submitting the statement regarding the real beneficiary is extended by 6 months from the termination of the state of emergency, and during the state of emergency the submission of the statement is suspended

    UPDATES


    On the Senate’s website a Draft Law on the amendment https://www.senat.ro/legis/PDF/2020/20b107FG.PDFand completion of Law no. 227/2015 regarding the Fiscal Code as well as other normative acts was published.


    Order no.705/2020 for the approval of the model and the content of the form (390 VIES) “Recapitulative statement regarding intra-Community supplies / acquisitions / services” was published Official Gazette no. 217/2020.

    Form 390 is updated as a result of the implementation of the “Quick fixes” Directive within the Fiscal Code, given that the taxable person must include within the Recapitulative statement information regarding the VAT ID of the taxable persons to whom the goods are shipped or transported under the call-of stock structures regime.


    Order no. 706/2020 for the amendment of Order no.3386 / 2016 for the approval of the model and contents of forms 101 “Corporate income tax statement” and 120 “Statement on excise duties”  was published Official Gazette no. 217/2020.

    Form 120 is amended as a result of the removal of excise payers’ obligation to turn over 1% of the excise duties due for cigarettes and alcoholic beverages to the Ministry of Tourism and Sport, as well as the removal of their obligation to pay a contribution to finance certain health expenses.


    Emergency Ordinance 33/2020 regarding certain fiscal measures and the amendment of certain normative acts was published in the Official Gazette 260/2020

    Following the previous fiscal measures adopted in the context of COVID-19, a bonus will be granted to taxpayers that pay by April 25, 2020 the corporate income tax and the microenterprises income tax for the first quarter of 2020.

    During the entire state of emergency and 30 days after its termination, VAT is not required to be paid in customs on imports of medicines, protective equipment and other medical devices and equipment and sanitary materials used in COVID-19 control.


    Order no. 1793/2020 approving the level of the specific excise duty on cigarettes was published in the Official Gazette no. 265/2020.

    The level of the specific excise duty on cigarettes between April 1, 2020 and March 31, 2021 inclusive is 406,521 lei / 1,000 cigarettes.

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  • BANKING & FINANCE

    The ordinance proving a moratorium on loan installments has been enacted by the Government, and so has been competing legislation by Parliament, causing more instability. There are many uncertainties, the biggest being whether the Ordinance will remain in force at all – the Parliament has already adopted its replacement which is currently in its promulgation stage.

    Please see our initial article here which provides a summary of the original government ordinance (which we will call the “Moratorium Ordinance”) and its recently published implementation norms (the “Norms”).

    This now includes some comments on key differences as a result of the current form of the version adopted by Parliament (which we will call the “Moratorium Law”).

    There were several aspects which the Moratorium Ordinance did not address which we believed could have resulted in several difficulties for both the banks and the companies. These are largely not addressed in the Moratorium Law either, which is in fact more succinct than its predecessor.

    It remains advisable that the companies, as well as the banks should be mindful when it comes to applying such measures, especially with regard to the restructuring of credit agreements, due to the fact that:

    • the postponement may apply to a limited number of companies – under the Moratorium Ordinance borrowers were eligible regardless of size provided they had to observed certain restrictive legal requirements (such as holding a state of emergency certificate); under the prospective Moratorium Law, only small and medium sized companies are eligible and no certificate is required as long as they declare a 15% decrease in revenue in the current month compared to the average of the last two months;
    • companies with previous unpaid debts are not eligible – however if the Moratorium Law comes into force, such debts would need to be older than 90 days in order to render companies ineligible;
    • changes to contracts may not be effective against co-debtors or third party guarantors – the Implementation Norms provide that prior consent of third parties is requires in respect of debtors who are legal entities;
    • the Moratorium Law includes provisions on banning enforcement procedures, the full scope of which remains unclear at this stage as the language is highly interpretable;
    • the obligation to file for insolvency has not been suspended in either piece of legislation, as it has been in Germany, for example (there are, however, certain contractual solutions) and penalties are still accruing for different kinds of commercial obligations making way to a new wave of insolvencies;
    • it is debatable whether the reimbursement of cross-border loans is covered by postponement measures currently in place.

    Please also see our extended article available here with regard to the insolvency wave approaching.


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  • PHARMA & MEDICAL SERVICES; CLINICAL TRIALS

    Special Measures Any transportation of medical devises or sanitary materials which ensure the prevention and treatment of the medical conditions associated with COVID -19, as well as the medicine provided in the National Catalog of medicine prices authorized for market purposes in Romania (i.e., CaNaMed), for the purpose of being distributed outside Romania, is prohibited. An exemption is granted to ensembles and spare parts of medical equipment produced in Romania for external beneficiaries. Other such exemptions may be granted by Order of the Health Minister.

    – as per Military Ordinance no. 1 of 17 March 2020, as further amended and supplemented

    Medical devices
    During the state of emergency the registration of medical devices (such as class I medical devices, in-vitro medical devices, custom made medical devices and active implantable medical devices) are exempted from registration in the national data base to the extent they are related to the prevention and treatment of conditions appeared in the context of state of emergency. Such medical devices shall be introduced on the marked by the manufacturer/ authorized representative based of statement of conformity.
    Also, no notification regarding the commissioning of medical devices related to the prevention and treatment of conditions appeared in the context of state of emergency shall apply.
    Ministry of Health Order no 537/ 2020

    During the state of emergency, out patient medical services (physical medicine and rehabilitation) and palliative care shall be provided without the medical referral.
    Further during such state,  medical consultations, including by any remote means, shall be provided by family doctors and specialty doctors from the out patient clinics and costs shall be incurred as per the applicable provisions in the field of consultations at the medical office/ out patient clinic.
    Ministry of Health Order 539/ 2020

    Sportsmanship related transparency obligations are due by June 30, 202 for medicinal products and by 31 July for medical devices and sanitary materials.
    Ministry of Health Order 538/2020

    European Commission working on proposal to postpone the Medical Device Regulation application date for 1 year

    The Commission announced that work on a proposal to postpone the date of application for the Medical Device Regulation (MDR) for one year is ongoing. The decision was reached with patient health and safety as a guiding principle.

    The Commission is working to submit this proposal in early April for the Parliament and the Council to adopt it quickly as the date of application is the end of May.

    This decision will relieve pressure from national authorities, notified bodies, manufacturers and other actors and will allow them to fully focus on urgent priorities related to the coronavirus crisis.

    European Commission press release

    Clinical trials Starting with March 24, 2020, no visits of persons enrolled in clinical trials may be performed except as decided by the principal investigator (in case of emergency/ any delay may affect the safety of the patient).

    In all cases not having an urgent nature, the National Agency for Medicines and Medical Devices of Romania (NAMMDR) recommends as follows:

    • re-scheduling of visits or replacing them with conference calls;
    • identification of solutions for at home delivery of treatment;
    • supervisions by remote means;
    • suspension of initiation of new clinical trials/ new investigation centers.

    as per NAMMDR press release on measures imposed by the said authority further to Order 74527/2020


    In the COVID-19 context, NAMMDR shall prioritize the assessment of clinical studies for medical drugs against COVID-19; depending on number of requests and the phase of the study (the prioritization is of phase III), the estimate for completion of assessment is of max 7 days.

    VHP procure for EU coordinated assessment is also considered and to this the assessment schedule shall be mutually agreed together with the other Member States.

    as per NAMMDR press release


    Also, in the field of clinical trials, the European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the coronavirus disease (COVID-19) pandemic.

    The guidance provides concrete information on changes and protocol deviations which may be needed in the conduct of clinical trials to deal with extraordinary situations, e.g. if trial participants need to be in self-isolation or quarantine, access to public places (including hospitals) is limited due to the risk of spreading infections, and healthcare professionals are being reallocated.

    This guidance includes a harmonized set of recommendations, to ensure the utmost safety of trial participants across the European Union while preserving the quality of the data generated by the trials. It also advises how these changes should be communicated to authorities.

    There is specific advice on the initiation of new clinical trials for treatments of COVID-19, and in particular on the need for large, multinational trial protocols. This is in line with the call issued on Thursday by EMA’s human medicines committee (CHMP) for robust trial methodology in clinical trials for potential COVID-19 treatments or vaccines.

    The guidance was agreed by the Clinical Trials Expert Group (CTEG) of the European Commission, supported by EMA, the Clinical Trials Facilitation and Coordination Group (CTFG) of HMA and the GCP Inspectors’ Working Group. It provides a harmonized approach in the conduct of trials, in order to mitigate the negative effects of the pandemic.

    The guidance text is available here.

    Global regulators map out data requirements for phase 1 COVID-19 vaccine trials

    Global regulators have published a report (available here) presenting the outcomes of a workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).

    The meeting report provides an overview of regulatory considerations related to COVID-19 vaccine development and data required for regulatory decision-making on two key points:

    • pre-clinical data required to support proceeding to first-in-human clinical trials with investigational medicinal products; and
    • the need to address the known theoretical risk that vaccines against COVID-19 enhance the disease prior to starting first-in-human clinical trials.

    All participants in the meeting acknowledged the urgency of conducting first-in-human clinical trials with COVID-19 vaccine candidates. The conclusions set out how regulatory authorities around the globe intend to strike the balance between rapid development of vaccines and the need to generate enough robust data to enable decision-making.

    EMA press release

    Hospitalization Starting with March 24, 2020, for a period of 14 days, the following are suspended: in-hospitalization for surgical interventions and other treatments and medical investigations which do not have an urgent nature and may be rescheduled, as well as the scheduled consultations/ scheduled consultations in outpatient care (irrespective in public or private).

    – as per Order 74527/2020 regarding the necessary measures in view of limitation of spread of infection with SARS – Cov-2 virus at the level of public and private sanitary institutions

    Dental medicine As of 22 March 2020, 22:00 hours, activity in dental medicine offices, except for urgent dental interventions, is temporarily suspended.

    – as per Military Ordinance no. 2 of 21 March 2020


    Your Contacts:

  • CERTIFICATES FOR EMERGENCY SITUATIONS

    The awaited regulation by the Ministry of Economy, Energy and Business Environment on issuance of the Certificate for emergency situations (“CES”) has been adopted through Order 791/2020 relating to the granting of emergency certificates to the economic operators whose activity is affected in the context of SARS-CoV-2 pandemic published on 25 March. The order sets the framework for the concept introduced through the Presidential Decree imposing the state of emergency and then further regulated through Emergency Government Ordinances no. 29/2020 and no. 30/2020. The electronic platform (available here) required for issuance thereof is expected to be functioning within 5 days as of publication thereof.

    Main highlights of such newly enacted concept:

    Who is entitled to receive CES The Ministry will issue the CES, at the request of economic operators entitle to receive them based on the provisions of art. X of the Emergency Government Ordinance no. 29/2020 and respectively Emergency Government Ordinance no. 30/2020 i.e., an applicant.

    The main categories of protections in relation to which CES may be used are:

    • OUG 29/2020, art. X – the right of the small and medium-sized enterprises impacted by the decisions taken by public authorities during the state of emergency period, in view of benefiting from postponement of utility services such as: electricity, natural gas, water, internet and telecommunication services, as well as the postponement of payment of rent for the headquarters and secondary locations
    • OUG 30/2020, art. XI – in relation to employees protection measures (e.g. technical unemployment)
    CES will be available in two categories/types
    • Type 1 (Blue) – applicable for economic operators whose activity has been totally or partially interrupted as a result of the measures imposed by public authorities during the state of emergency period;
    • Type 2 (Yellow) – applicable for economic operators who registered a decrease in payment receipts of at least 25% in March compared to the average payment receipts registered in January-February 2020.

    Note: the applicant may submit the documentation for only one type of CES.

    CES are used in the relationship with the public authorities in order to obtain specific facilities/ support measures or in the commercial relationships according to the applicable legal provisions.

    Granting methods Requests for the issuance of CES shall be made exclusively through electronic means, respectively a platform provided by the Government here. CES will be issued automatically after validation by the system.

    The solicitor shall submit the following data:

    (i)    identification data;

    (ii) an Affidavit of the legal representative stating that all the information and documents supporting the request are accurate and in line with the legislation in force, as regards each type of CES requested, with reference to the total or partial shutdown of activity or decrease of earnings within the indicated amount.

    In case the legal representative of the solicitor does not have an electronic signature, the documentation may be signed with a wet signature, with the condition that all the documents uploaded on the platform will then be signed electronically by an authorized representative for this purpose. Therefore, all documents uploaded on the platform must have an electronic signature.

    Miscellaneous
    • A standard form for the Affidavit is available in the respective order;
    • Solicitors who are not registered with the Trade Register Office shall provide the information and documents indicated above, including documents with regard to the authorization of the activity.
    • CES will be granted only for the duration of the state of emergency, as such was declared by the State;
    • CES are valid without a signature or stamp;
    • Competent authorities shall verify the documents on which the Affidavit is based during inspections. In case of reasonable suspicions as regards the procedure of obtaining the CES without observing the legal provisions or by not presenting the accurate situation of the applicant, competent authorities will enforce appropriate measures.

    Your Contacts:

  • OTHER GENERAL MEASURES SO FAR

     Retail As of 22 March 2020, 22:00 hours, retail of products and services in shopping centers in which several economic operators carry out their activity, except for the sale of food, veterinary or pharmaceutical products and cleaning services, is temporarily suspended.

    Shopping center” means a sale structure with a medium or large area in which activities for the retail of products and services and food service activities are carried out, using a common infrastructure and adequate utilities.

    – as per Military Ordinance no. 2 of 21 March 2020

    Retailers need to also consider recommendations and guidance issued by other competent authorities. In its 25 March 2020 communication, the National Sanitary and Sanitary-Veterinary Authority:

    • recommended to retailers to ensure a minimum social distance of 1,5 m between customers;
    • set rules providing that lamb meat coming from farms will be sold directly to the final consumer and will not be delivered in sanitary veterinary authorized or registered units.
    Food service The activity of serving and consumption of food, alcoholic and non-alcoholic drinks performed by restaurants, hotels, coffee houses and other public establishments, in spaces destined for this activity, inside or outside the location, is suspended.

    The entities mentioned above i.e. restaurants, hotels, coffee houses etc. may still perform their activity for commercializing food and alcoholic or non-alcoholic drinks if the customers do not remain in said premises for that purpose, meaning the activity may continue in situation such as: “drive in”; “room-service”; “delivery to client”.

    – as per Military Ordinance no. 1 of 17 March 2020, as further amended and supplemented

    Entertainment All cultural, scientific, artistic, religious, sport, entertainment or gambling, spa and personal care treatments performed in closed spaces are suspended.

    – as per Military Ordinance no. 1 of 17 March 2020, as further amended and supplemented

    Transport services Cargo transportation drivers with a maximum authorized capacity which exceeds 3.5 tones, when approaching border crossing points must be equipped with individual protection means such as: sanitizer, masks, gloves as well as documents attesting the envisaged transportation route. Said drivers arriving from “read” or “yellow” areas or who have crossed such areas, will not be subjected to the quarantine or isolation protocols if they do not show symptoms of COVID -19 at the border crossing points. The above measures also apply to drivers of cargo transportation with authorized capacity of over 2.4 t.

    All flights operated by economic operators towards Spain and from Spain to Romanian are suspended for all airports in Romania for a period of 14 days as of 18 March, 18:00 pm CES.

    Suspension of all flights operated by economic operators towards Italy and from Italy to Romania is extended for 14 more days as of 23 March 2020. An exemption is granted to flights performed by state aircrafts, flights pertaining to transportation of cargo and mail, humanitarian flights or those who ensure services of medical emergencies, as well as to non-commercial technical landings.

    – as per Military Ordinance no. 1 of 17 March 2020, as further amended and supplemented

    General measures People may venture outside their home / household only in compliance with the general measures for preventing the spread of COVID-19 and by avoiding the formation of any group of people.

    • Forming a group of people” means more than 3 people who do not live together.

    As of 25 March, 12:00 pm persons are prohibited to venture outside their home / household at any hour during the day or night, except for the following reasons:

    1. travel for professional interest, including between their home / household and the place (s) where they conduct their activity and back;
    2. travel for the purpose of acquiring goods that cover the basic needs of persons and pets / domestic animals, as well as goods necessary for their professional activity;
    3. travel for medical assistance that cannot be delayed or carried out remotely;
    4. travel for justified reasons, such as caring for / accompanying children, assistance of the elderly, sick or disabled or death of a family member;
    5. short trips, close to their house / household, related to the individual physical activity (with the exclusion of any team sporting activities) and the needs of pets / domestic animals;
    6. travel for the purpose of donating blood, at the blood transfusion centers;
    7. travel for volunteering or humanitarian purposes;
    8. travel for the performance of agricultural activities;
    9. travel of agricultural providers for the commercialization of agri-food products.

    Moreover, people over 65 years old may venture outside their home/household, only between 11:00 AM – 13:00 PM and only for the following reasons:

    1. travel for the purpose of acquiring goods that cover the basic needs of persons and pets / domestic animals;
    2. travel for medical assistance that cannot be delayed or carried out remotely;
    3. travel for justified reasons, such as caring for / accompanying children, assistance of the elderly, sick or disabled or death of a family member;
    4. short trips, close to their house / household, related to the individual physical activity (with the exclusion of any team sporting activities) and the needs of pets / domestic animals;

    By exception, persons over 65 are allowed to venture outside the said timeframe if they provide proof that they travel in professional interest or for the performance of agricultural.

    In order to prove the reason of the trip as indicated above, the following documents must be made available to the personnel of the public local authorities at their request, as they will enforce the prohibitions hereunder:

    1. employees will present the service card or , a certificate issued by the employer.
    2. authorized natural persons, titleholders of individual enterprises, members of family enterprises, self-employed professionals and people who carry out agricultural activities will present a sworn affidavit;

    In order to prove that a trip is made for other personal reasons than those above, people are under the obligation to present, upon request, to the personnel of the competent authorities, a sworn statement previously filled in with information such as: (i) identification data; (ii) reason of travel; (iii) date and signature. The certificate issued by the employer or the sworn affidavit can be presented to the authorities by means of a telephone, tablet or other similar electronic device;

    as per Military Ordinance no. 3 of 24 March 2020

    Foreign citizens and stateless persons are forbidden from entering Romanian territory, through state border crossing points, except when they are in transit through Romanian territory by transit corridor organized by agreements with the neighboring states;

    Foreign citizens/ stateless persons are exempted from the aforementioned interdiction if they fall within any of the following categories:

    1. they are family members of Romanian citizens;
    2. they are family members of citizens of other Member States of the European Union or of the European Economic Area or of the Swiss Confederation, residing in Romania;
    3. they hold a long-stay visa, a residence permit or a document equivalent to the residence permit issued by the Romanian authorities according to the Government Emergency Ordinance no. 194/2002 regarding the regime of foreigners in Romania, republished, with subsequent amendments, or a document equivalent to aforementioned issued by the authorities of another state, as per European Union laws;
    4. they are traveling for professional interest, evidenced by visa, residence permit or other document equivalent;
    5. they are diplomatic or consular personnel, personnel of international organizations, military personnel or personnel who can provide humanitarian aid;
    6. they are passengers in transit, including those repatriated as a result of granting consular protection;
    7. they are passengers traveling on imperative grounds (medical or family);
    8. they are persons who need international protection or for other humanitarian reasons.

    People that are isolated at home, as a measure for preventing the spread of COVID-19, who leave the place where they were isolated, without the approval of the competent authorities, are deemed persons with high risk of infectiousness and are placed by public order forces in institutionalized quarantine, under guard. People that are quarantined, as a measure for preventing the spread of COVID-19, who leave the place where they were quarantined, without the approval of the competent authorities, are quarantined for another period of 14 days.

    Local public authorities are under the obligation to identify and keep record of the elderly people over 65 that do not benefit from support from other people or other form of help, and to provide them with support in order to minimize their exposure outside homes.

    All people entering Romania as of 25 March 12:00 PM will enter into mandatory quarantine or self-isolation at home as the case may be.

    – as per Military Ordinance no. 2 of 21 March 2020 as further amended and supplemented.

    Religious services can be officiated in churches by priests or clerk servants, without public access, as religious services can be broadcasted by the mass-media or online;

    Private religious services such as (baptism, weddings, funerals) may be officiated with maximum 8 persons;

    – as per Military Ordinance no. 1 of 17 March 2020 as further amended and supplemented

    Insurance As of April 1, 2020 and until the state of emergency is in force all taxes, fees, quotas and contributions due by regulated entities towards the Financial Services Authority shall be reduced with 25%;

    Reporting obligations during the state of emergency shall be performed electronically by using the details provided in the link available here.


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    NNDKP facilitates access to global information resources that tackle the impact of COVID-19 in various countries around the world. These include multi-jurisdictional reports and country-specific updates prepared by leading independent law firms across the world.

    We invite you to visit the dedicated hubs created by the high-profile global and regional professional networks in which NNDKP is the exclusive member firm for Romania:

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DISCLAIMER
Nothing in this section should be construed as legal and/or tax advice. This section is necessarily generalized. Professional advice should therefore be sought before any action is undertaken based on this section.