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30 March 2020

Bulgaria: healthcare & life sciences in a global pandemic

Healthcare and life sciences have a special status as a type of legal practice. The debate about what this specialisation entails, and to what extent it even qualifies as legal work, is endless. However, as a crisis is also an opportunity, the coronavirus pandemic has defined the areas where law, healthcare and the life sciences overlap.

It is now clear that the COVID-19 crisis has the greatest impact on hospitals, pharmaceutical and medical device companies. They needed to quickly set up sustainable emergency management systems to maintain their normal operations. At this point, the sector is also expected to provide a practical solution to the COVID-19 crisis as soon as possible, before the economic crisis becomes unmanageable.

The crisis raises several legal and commercial issues for the healthcare and life sciences sector. Below we have attempted to provide a brief summary of them.

Telemedicine needs flexible regulation

Bulgaria is suffering from a shortage of healthcare professionals. Now it is even more difficult for the patients to find adequate medical care at the healthcare facilities – quarantine is an important tool to limit the spread of the infection.

Right now, digital medicine and telemedicine are especially important, because they can provide patients with access to medical care. In a quarantine situation, healthcare can take advantage of existing global concepts for digital medicine and telemedicine. Thus, each patient can be referred to appropriate medical care without being threatened with infection. We can see that it is working. For example, a high-profile healthcare emergency unit is providing online advisory for the treatment of emergency cases in the locked down town of Bansko.

In addition, it is necessary also to refine the Bulgarian legislation on electronic prescriptions and create a legal framework for digitalisation of orders and deliveries of all types of medicines.

Clinical trials

COVID-19 is already causing changes in the timing of many studies, which in some cases may lead to deviations from sponsors' plans.

On 20 March 2020, the European Medicines Agency published recommendations for sponsors and researchers on how to manage clinical trials in the context of the COVID-19 pandemic ("Guidance").

In addition to providing specific advice on the launch of new clinical trials for COVID-19 treatment, the Guidance aims to serve as a harmonised set of recommendations at the EU level. It provides specific information on changes and deviations from the protocols that may be required in clinical trials performed during the state of emergency or quarantine.

The Guidance also includes tips for ensuring the safety of research participants and maintaining the quality of the data generated, such as:

  1. Changes in the consent declarations.
  2. Changes in the course of ongoing trials: replacement of physical check-ups with telephone or video conferences, temporary suspension of the process, suspension of patient recruitment, etc.
  3. Risk assessment: All clinical trial adaptation decisions should be based on the sponsor's risk assessment. In it, priority is given to the safety of the research participant and the validity of the data. In case of a conflict between these two parameters, safety should always prevail.
  4. Communication with authorities: Pharmaceutical companies should review the effects of COVID-19 on upcoming and ongoing clinical trials, revise any existing study concepts and, if necessary, provide notices to the relevant competent authorities.

Delayed deliveries

Many manufacturers of raw materials and generic medicines in India and China have limited or stopped production to control the spread of the disease. Delays in deliveries can lead to difficulties in supplying life-sustaining medicines as well as to illegal imports or the release of pirated products on the market. The latter is greatly facilitated by the development of e-commerce and the inability of the competent authorities to track the deliveries.

Pharmaceutical companies should review their contractual rights to limit the negative effects of the delayed deliveries on trade.

Medical devices

According to information from mid-March, the Bulgarian Ministry of Health is working on drafting an amendment to the Bulgarian Medical Devices Act. An interagency working group has been set up on this project. According to official information from the Ministry of Health, the draft amendment to the Medical Devices Act will be published for public discussion before 26 May 2020, the date on which the implementation of Regulation 2017/745 starts.

This means that in practice, the adaptation of national legislation to the directly applicable Regulation 2017/745 is likely to be delayed. For a certain period after 26 May 2020, there may be administrative ambiguity regarding the competencies of the Bulgarian Drug Agency for the registration and placing on the market of medical devices. Therefore, our advice to manufacturers is to take into account the above information when planning for the Bulgarian market.

Communication from the Bulgarian Competition Protection Commission

On 25 March 2020, the Bulgarian Competition Protection Commission (CPC) officially notified the application of certain competition rules in the context of the COVID-19 state of emergency.

In its communication, the CPC emphasises that, despite the state of emergency, market participants are obliged not to prevent, restrict or distort competition through their actions. To ensure that the public will have access to products important for public health protection as well as essential products, the CPC states that it will very closely monitor the pharmaceutical and food industries as well as trade.

Food safety

According to an FSA report, the virus that causes COVID-19 is unlikely to be caught through food. COVID-19 is a respiratory disease and is currently not known to be transmitted through food or food packaging.

According to information from the food industry, the Bulgarian control authorities are working hard to ensure that food business operators know what their responsibilities are and what action they need to take to maintain high standards of safety and security of their personnel.