With the rapid development of pharmaceuticals and new medical procedures, the liability of those involved in patient treatment is becoming a subject of serious discussion.
In this newsflash you will find our view of the current situation in our countries, as well as suggestions as to what should be improved and clarified in the interests of healthcare providers, the medical industry ‒ and patients.
While some regulation exists on medical treatment-related risks in the Baltics and Belarus, nevertheless regulation is neither complete nor clear in every aspect, so these legal issues need exploration and further development.
Authors: Senior associate Lise-Lotte Lääne, counsel Pirkko -Liis Harkmaa
Competition Authority pushes for stricter price regulation
On 1 September 2020 the Estonian Competition Authority (ECA) published the results of its analysis of the effectiveness of price regulation of pharmaceuticals in Estonia. The report can be found here (available only in Estonian).
The highly critical report’s main conclusion was that wholesale purchase prices of pharmaceuticals are not presented correctly due to the use of arguable bonus systems, credit invoices and fees for additional services. The ECA is of the opinion that the current regulation of mark-ups for pharmaceuticals is harmful to competition, consumers and even to the efficient use of health insurance resources.
According to the report, the problem is caused mainly by the fact that neither the ECA nor the State Agency of Medicines has the authorisation to supervise the prices at which wholesalers claim to purchase pharmaceuticals and it is not possible to impose fines. Due to lack of proper supervision, there is a considerable risk of material non-compliance with the price regulation rules.
In order to bring clarity to the formation of purchase prices, the ECA considers it necessary to establish a seamless set of rules on pricing. The purchase price should be clearly defined, including from a procedural point of view. The ECA considers that a ban on certain types of rebates or other netting schemes is also worth considering.
The report received immediate and extensive media coverage. The Minister of Social Affairs, Tanel Kiik, said on live news that the Ministry of Social Affairs, the State Agency of Medicines and the ECA will meet in the very near future to discuss how pricing regulation should be changed. Pharmaceutical market participants are bound to have exciting times ahead of them.
Adoption of Patient Insurance Act still on hold
For at least a decade, discussion has focused on whether Estonian laws are in need of a specific patient insurance regulation. In 2019, the Ministry of Social Affairs prepared a draft for establishment of liability insurance of a health care provider (medical institution). Along with adoption of the Patient Insurance Act, the plan was to modernize the patient safety system in order to facilitate reporting and prevention of medical errors.
The aim was (is) to create no-fault insurance that compensates the patient for damage incurred under healthcare. In contrast to the existing system, compensation for health damage in the future would not depend on determining the guilt of the healthcare professional: all that matters is that the damage was reasonably avoidable. Additionally, the draft act foresees that a central health insurance fund will be set up to ensure uniform and effective compensation for patients’ claims.
The primary and most important goal of establishing the patient insurance system is to ensure the high quality of healthcare services and patient safety. One of the main problems with the current system is that healthcare professionals are not encouraged to report medical errors since the responsibility for errors falls primarily on themselves. This, however, means that it is not possible to learn from avoidable treatment errors or to work out strategies to improve patient safety.
Now, although the Patient Insurance Act is eagerly awaited and needed in the healthcare sector, the draft act is still on hold in the Ministry of Social Affairs. According to publicly available information, the Ministry of Economic Affairs and Communications and Ministry of Finance did not approve the draft act in summer 2019, and there has been no progress since. Hopefully the standstill will not last another decade.
Checking body temperature at workplace? Then you should check GDPR compliance as well
One way to minimise the spread of the Covid-19 virus in the workplace is to screen the body temperature, since elevated body temperature may be a possible symptom of infection
However, temperature screening is not merely a health and safety related measure, but involves processing of employees’ health data, and so falls under the scope of GDPR requirements. While the Estonian data protection and labour authorities have been quite cautious on giving specific guidance for using temperature screening and have stressed only that any such screening requires agreement of employees, a number of other factors also need to be considered:
- A basic body temperature check involving use of a conventional manual thermometer without registering the measurement by the employer would not as a rule fall under the scope of the GDPR. However, if based on the measurement an employee is denied access to the workplace and the absence of the employee is documented by the employer, the reason for absence and the employee’s identity can be linked and would thus be considered processing of health data under the GDPR.
- Basic body temperature checks involving use of a conventional manual thermometer and followed by registering the measurement or performing an identity check of the employee will always fall under the scope of the GDPR.
- Temperature screening based on the use of thermal scans or thermal cameras also falls under the scope of the GDPR and may qualify as automated processing and should therefore be completely voluntary and should also involve human intervention and the possibility of repeated checks especially if as a result of automated screening the employee is denied access to the workplace.
- Regardless of the method used for temperature screening, appropriate data protection safeguards should be in place (for example automated systems should be separate from other IT systems and identity check system, real-time systems should be preferred over recording, and the data that manufacturers of the systems being used have access to in connection with their maintenance or support services should be established) and any method should be devised so that the data collected is minimised.
- Employees should be made aware of the details of processing of their health data and relevant data privacy notices and internal rules for conducting the temperature screenings and processing of employee health data should be in place, not to mention the appropriate consents from employees agreeing to screening.
Body temperature screening always interferes with an employee’s fundamental right to a private life. So, before deciding to implement it, the employer should assess the legality, necessity and proportionality of such a measure and first choose health and safety measures that involve less interference in the private life of the employee. If body temperature screening is found to be a necessary and proportionate measure, the employer should carefully consider all requirements under the GDPR and have in place adequate documentation proving compliance with the GDPR.
Authors: Partner Ieva Andersone, legal assistant Gunvaldis Leitens
Managing medical risks in Latvia – now 5 years old, special risk fund system still requires improvement.
While modern medicine is aimed at maximum efficiency and patient comfort, this does not mean that it is risk-free. Patient treatment is a complicated procedure, involving the expertise of healthcare specialists and advanced technological and pharmaceutical solutions. So, an easily understandable and accessible procedure for resolving any deficiencies in treatment should be accessible to every patient.
In Latvia any damage caused due to mistakes by healthcare professionals is compensated through the Medical Treatment Risk Fund (Fund). This functions on basis of Cabinet regulation No. 1268 “Rules on the Operation of the Medical Treatment Risk Fund” (Regulation), implementing the provisions set in EU Directive 2011/24/EU.
The Fund is operated by the Health Inspectorate and the National Health Service. While the competence of the Health Inspectorate covers assessment of patient applications and adopting decisions on payment or refusal of compensation, the National Health Service is responsible for administrating financial resources and organising payments.
Currently, the maximum health damage compensation is EUR 142,290. In addition, patients may claim reimbursement of additional healthcare costs up to EUR 28,460. During the first five years of operation of the Fund, the average amount of compensation has been approx EUR 22,000.
Need for a wider competence
As set in the Law On the Rights of Patients, the Fund compensates damage caused to a patient’s life or health caused by healthcare professionals working in a medical treatment institution through their conduct or failure to act or caused by conditions during medical treatment. Accordingly, the Fund does not compensate damage caused by deficiencies in medicinal products or devices. This means that a patient who has suffered damage due to failure of a medicinal device or a defective medicinal product can only claim compensation through civil court proceedings against the producer. This leads to the conclusion that in practice the Fund is only partially performing its main purpose.
In future policymakers may assess whether the Fund could also be used in specific cases to compensate damage caused by deficient medicinal devices or medicinal products, such as pharmaceuticals or vaccines.
Timely assessment of applications
Since the Fund began its operation in 2015, the patient application processing time has been a subject of public critique.
The Regulation provides the forms necessary for patients to fill in if they are interested in claiming compensation. However, the patient is still responsible for providing the National Health Inspectorate with evidence of damage and expenses. In the case of non-compliance with the claim requirements, the patient is given one month to supplement the application. So, the claim can sometimes take up much time and be cumbersome.
However, if the necessary patient data could be sent directly from the healthcare institution to the National Health Inspectorate at the patient’s request, this would decrease the possibility of human error and speed up the process of claim and further assessment. Accordingly the application procedure should become more automated and less patient-reliant, thereby increasing work efficiency.
New rules imposed on geographic location of pharmacies
In order to promote more rational placement of pharmacies and increase the availability of medicines in less populated areas, the Ministry of Health has reviewed the geographic and demographic criteria for locating pharmacies. These changes are expected to help decrease the number of pharmacies operating in Latvia from 766 to approximately 480, while also increasing the quality of pharmacy services.
On 13 August 2020 The Ministry submitted a new draft law (in Latvian) to replace Cabinet Regulation No. 610 “Criteria for the Location of Pharmacies and Pharmacy Branches” to the State Secretary Meeting.
The conditions set by the new regulation will not apply to pharmacies operating since before it came into force. However, any location changes afterwards will have to comply with the new criteria.
The new regulation envisages that in the future only one pharmacy will be allowed to operate in a populated area with a population of 4000 or less. The current regulation allows the operation of not more than two pharmacies under these circumstances. According to the ministry, this practice has not proved to be effective for promoting competition among market participants and increasing the quality of pharmacy services.
For populated areas with a population over 4000, the maximum number of pharmacies will be determined by dividing the number of inhabitants by 4000. The result after rounding to an integer will determine the maximum number of pharmacies allowed to be located in the particular populated area.
Additionally, opening new pharmacies closer than 500 m to any pharmacy already operating will not be allowed. However, a general exception to this rule will apply to pharmacies operated by pharmacists registered as individual merchants or pharmacies fully owned by a single pharmacist. This exception will apply unless the pharmacist owns more than two pharmacies or changes the location of pharmaceutical activity more than once in three years.
The restriction will also not be applicable, if:
- The location changes within the premises of a single building.
- The location has changed within a 100 m radius once in a three-year period.
- The pharmacy is opened in a shopping centre with an area of at least 10 000 m2 and at least 10 lessees located in its premises, where a single lessee does not exceed 70% of the shopping centre area. However, only one pharmacy will be allowed in the premises of each shopping centre.
- The pharmacy is opened in the grounds of a hospital. However, only one pharmacy can be located in the grounds of each hospital, regardless of the number of buildings in the grounds.
Distances between pharmacies will be set and monitored in accordance with a map maintained by the State Agency of Medicines. The distance will be measured as a straight line between the entrances of pharmacies.
Authors: Senior associate Irma Kirklytė, senior associate Erika Žigutė
Quicker registration procedure for medicinal products introduced
On 14 July 2020, the Ministry of Health affirmed the new quicker, so-called‘zero day’ registration procedure for certain medicinal products. Under this procedure, it would take only 44 days to register a medicinal product in Lithuania.
The ‘zero day’ registration procedure is another application of the principle of mutual recognition within the European Economic Area (EEA). The procedure is applicable for medicinal drugs that have been registered in another EEA country with mutual recognition or decentralised procedure. In other words, this means that a medicinal product must be approved for its quality, safety and efficacy by at least two other EEA countries.
For comparison, the regular procedure takes up to a year, so the new procedure makes entry to the market significantly easier.
The “zero day” procedure is also applicable in Malta, Cyprus and Iceland.
Patient compensation system reformed, ‘no fault’ model adopted
On 1 January 2020, the rules on compensation for harm caused by medical treatment were significantly changed.
The reforms aim to (i) encourage healthcare professionals not to hide their mistakes and to decrease the practice of ‘defensive medicine’, where certain risky treatments may not be provided because the healthcare professional does not want to risk being liable for any harm caused; (ii) make compensation of damage to patients’ health more accessible, to simplify the procedures, make it less costly and time consuming.
Before the reform, patients harmed by medical treatment had to rely on regular procedures of civil liability, i.e. prove the necessary elements of civil liability: i) harm ii) malpractice by the healthcare professional; iii) a causal link between the harm and the malpractice. Also, patients had to file a claim against the clinic first. In the case of rejection, patients then had to apply to the commission on assessing damage inflicted upon the health of the patient (the Commission). If the decision of the Commission was unfavourable, the patient only then could apply to the court.
What is new under the “no fault” model?
- The patient no longer needs to prove all elements of civil liability. Instead, the patient only needs to provide information proving harm to their health.
- the procedure has been simplified, since the patient fills out a pro-forma template that requires no legal knowledge and submits it directly to the Commission, which then gathers any expert evidence, if necessary;
- the amount of compensation for non-pecuniary harm is clearly established in secondary legislation, which provides clarity for both patients and the Commission (eg, severe disability is compensated by 19 000 EUR).
A patient can submit their claim to the Commission free of charge and can also appeal the Commission’s decision to a first instance court. Compensation would be awarded from a special fund that each clinic must contribute to. The right of recourse against a healthcare professional who caused the damage and / or the clinic would only occur in the case of intentional damage or if the professional was intoxicated when providing medical treatment.
However, patients may not be compensated in certain cases established by law, e.g. where the harm was unavoidable (e.g. harm was due to the individual health condition of the patient or diseases the patient already had); or if the patient contributed to the harm.
It is interesting to note that together with the new model, sanctions for healthcare professionals for committing mistakes were also relaxed, for example, now they can only lose their licence if they commit two serious mistakes, while previously one serious mistake could be enough.
As to practical concerns in the “no fault” model, doubts have been expressed whether the Commission will be able to respond to patients’ claims in a reasonable time, given the likely increase in the volume of claims. Critics also worry that the special fund may not have enough funds and healthcare organisations may have to pay larger contributions, instead of spending those funds on treating patients. So far no information is publicly available as to whether there is already an increase in the number of patients’ claiming. Time will tell whether these concerns are justified.
Authors: Senior associate Marina Golovnitskaya, associate Yauheni Budchanka
Belarusian patients protected under general law
Compensation for harm caused to life and health due to deficient pharmaceuticals
Belarusian law does not contain special legislation on harm caused to life and health due to deficient pharmaceuticals. Instead, general civil law and consumer protection law would apply. For example, if someone is injured, compensation would cover income lost and additional expenses (eg, treatment costs, additional nutrition, pharmaceuticals purchased, nursing care, health resort treatment). Pharmaceutical marketing authorisation per se does not protect against liability.
Under consumer protection laws, harm caused to life and health due to deficient pharmaceuticals, as well as due to inaccurate or insufficient information about pharmaceuticals, is subject to compensation in full by either the seller or the manufacturer, at the claimant’s discretion. Compensation should be paid regardless of fault and of whether contractual relations exist(ed) between the disputing parties. The seller or the manufacturer will not be held liable if they prove that damage occurred as a result of force majeure or the consumer’s violation of rules for use of the pharmaceuticals.
Compensation for moral harm to a consumer is also possible and must be compensated in monetary form by the wrongdoer.
Generally, claims related to compensation of harm are brought as individual claimant lawsuits, but could be also brought by consumer protection bodies on behalf of an unlimited number of consumers.
Liability of healthcare professionals for improper performance of professional duties
Belarus law establishes criminal liability for improper performance of professional duties entailing serious or less serious bodily harm to the patient as a result of negligence on the part of healthcare professionals. Criminal liability implies different penalties: generally ranging from a simple fine to personal restraint up to two years. The particular penalty is defined by the court.
In terms of potential criminal liability, there is no definition of “medical malpractice” in Belarus legislation. Nevertheless, from the Belarusian law perspective, it is necessary to distinguish between two scenarios:
1) medical malpractice which does not imply fault on the part of healthcare professionals (so-called “bona fide mistakes”)
This scenario does not imply criminal liability. Sudden and newly diagnosed allergic reactions of patients serve as an example. If a new allergy has developed during medical treatment, it should not be qualified as the fault of the healthcare professional.
2) negligent or inattentive attitude of a healthcare professional, i.e. situations where it is possible to foresee a negative outcome of medical treatment
This scenario may lead to criminal liability. An example might be a situation when a healthcare professional fails to carry out a mandatory medical examination.
On a separate note, criminal liability of a healthcare professional can be excluded if several conditions are met simultaneously, namely:
- their actions aim at achieving a socially useful goal, i.e. saving the life and health of the patient;
- this goal could not be achieved by other means;
- these actions correspond to modern scientific and technical knowledge and experience;
- they reasonably believed that all possible measures were taken to prevent harm.
Finally, in addition to bringing healthcare professionals to criminal liability, an injured patient may consider filing an individual claimant lawsuit related to compensation of harm as mentioned above. These lawsuits may be filed against healthcare organisations where relevant professionals provide medical treatment.
To sum up, the cases described are associated with a range of difficulties. Firstly, they require an understanding of professional aspects in the field of medical treatment. Also, proving the amount of harm is challengeable and there is no special fund (similar to the Medical Treatment Risk Fund in Latvia) compensating damage suffered due to mistakes by healthcare professionals.