In this newsflash, you will find our overview of the COVID-19 vaccine development, accessibility and legal aspects, as well as an update on the new pharmaceutical strategy for Europe and other relevant news.
Our Life Sciences & Healthcare team is at your disposal should you need any advice on issues you are facing.
COVID-19 VACCINE. HOW ACCESSIBILITY WILL BE ENSURED AND WHAT HAPPENS IN CASE OF DAMAGE TO HEALTH
News on COVID-19 vaccine development
As the second wave of coronavirus accelerates, increasing hope is being put into a COVID-19 vaccine. Good news has been spread recently in relation to COVID-19 vaccine development – Pfizer-BioNTech announced preliminary results that suggested their vaccine was more than 90 percent effective – the U.K. was the first country to approve the vaccine for massive use and has already started vaccinating against COVID-19. Also an Oxford University-AstraZeneca vaccine research announced the latest news on trials, showing that the vaccine stops 70% of people from developing COVID-19 symptoms. Moreover, Pfizer-BioNTech have already filed for authorisation of their COVID-19 vaccine in the USA.
While the news on vaccine development is thrilling, we invite discussion on the following: the process of rapid development of COVID-19 vaccine and the safety risks that may result; also, are the Baltics ready for vaccination and how will accessibility to the vaccine be ensured?
COVID-19 vaccine breaks drug development records
At the beginning of December the U.K. approved a Pfizer-BioNTech COVID-19 vaccine. This makes the Pfizer-BioNTech vaccine the fastest vaccine to go from concept to reality, taking only 10 months, whereas the same steps normally take up to 10 years. In a regular procedure, a potential new treatment goes through several clinical trial phases that test the treatment for both safety and effectiveness before reaching patients. On average, clinical trial phases take six to seven years. Meanwhile, during the pandemic, clinical trials for COVID-19 vaccine have been conducted in a much shorter time than that.
The significantly shorter terms for clinical trials make it impossible to collect the same amount of reliable data, including data on rare side effects, of which manufacturers must inform consumers. Meanwhile, given the expected population to be vaccinated, even rare cases of side effects of the vaccine can turn into a large number of claims for compensation for damage caused to health.
European Union (EU) cooperates to facilitate development and authorisation of COVID-19 vaccine
The EU is contributing to COVID-19 vaccine development ‒ and not only financially: EU institutions are also cooperating to speed up the processes required for vaccine authorisation. For any medicinal product to enter the EU market, it must first be approved by the regulatory authorities. In this case, it is most likely that marketing authorisations for COVID-19 vaccines will be issued by the European Medicine Agency (EMA) under the Centralised Marketing Authorisation process.
The EMA has set up a special working group to liaise and provide scientific support to COVID-19 vaccine manufacturers. Also, the EMA is adopting a “rolling review” procedure to speed up assessment of a promising vaccine during a public health emergency. Normally, all data on a medicine’s effectiveness, safety and quality must be submitted at the start of the evaluation in a formal application for marketing authorisation. In the case of a rolling review, the EMA reviews data as soon as they become available from ongoing studies. For example, the rolling review of Pfizer COVID-19 and Moderna Biotech vaccines started in October and November 2020 respectively, while the first rolling review was initiated for a COVID-19 vaccine developed by AstraZeneca on 1 October.
Additionally, a COVID-19 vaccine may be subject to conditional registration, which means that the initial registration of the medicine will be based on less detailed data than would normally be required (however, the benefits must outweigh the risks), but authorization holders will be required to submit details later. It is expected that the first EU citizens may be vaccinated by the end of December.
In case of damage to health, Member States to share responsibility with vaccine manufacturers
In order to ensure sufficient production of vaccines in the EU and sufficient supplies for its Member States, the EU Commission is entering into Advanced Purchase Agreements (APAs) with individual vaccine manufacturers on behalf of the Member States. In order to compensate for high risks taken by manufacturers due to the speed-up in vaccine development (i.e. risks that may arise due to lack of information on the side effects of the vaccine), APAs provide for Member States to indemnify manufacturers for liability incurred under “certain conditions”. Further related terms of the APAs remain unrevealed by the EU Commission due to APA confidentiality clauses.
Normally, in case of damage to health caused by defective products, including medicinal products, manufacturers bear the responsibility. This rule is common and largely harmonized in all EU countries as it is established by the Product Liability Directive 85/374/EEC. The EU Commission claims that, regardless of APA terms, the Product Liability Directive will remain unchanged and will apply in case of damage to health caused by COVID-19 vaccine. So this should mean that Member States will most likely bear part of the financial burden of manufacturers for liability incurred due to defective COVID-19 vaccine, if this should be the case. However, it remains unclear what particular role Member States will play in indemnifying the manufacturers.
There is no publicly available information on how Estonia, Latvia and Lithuania will fulfil their commitments established by the APAs. Either way, in order to obtain compensation from the manufacturer, an injured person must prove damage suffered plus the defectiveness of the vaccine plus a causal relationship between the defective vaccine and damage to health. The defectiveness of a medicinal product may be established due to non-disclosure of all information relevant to the consumer, e.g. detailed information on adverse reactions. This aspect is particularly relevant in the case of COVID-19 vaccine.
At least in Estonia, due to legal nuances the chances of a damages claim succeeding are relatively low. Until now, there have been no court cases in Estonia where such damages would have been compensated due to an unsafe vaccine. It is also important to note that at the moment Estonian law does not distinguish between situations where vaccination takes place with a vaccine holding a marketing authorisation (MA) or with a vaccine not yet holding a MA. Estonia has not yet included in its legislation Art 5(3) of Directive 2001/83/EC which foresees that MA holders, manufacturers and health professionals must not be subject to civil or administrative liability for any consequences resulting from the use of an unauthorised medicinal product, when such use is recommended or required by a competent authority in response to the suspected or confirmed spread of pathogenic agents (e.g. COVID-19), toxins, chemical agents or nuclear radiation any of which could cause harm.
The Estonian Ministry of Social Affairs has submitted its proposal to the Estonian Parliament to adopt a law which would establish such ‘exclusion of liability’, but at the same time, they have not given any explanations as to who then would be responsible or how liability issues would be solved. We have submitted a relevant opinion to the Parliament saying that the proposal by the ministry infringes a person’s fundamental right to compensation. The fundamental right to compensation means that the legislator must always enact substantive legal bases for allowing/enabling damages claims. At the same time, damage need not be compensated by the person who caused the damage. For example, many countries have established so called ‘vaccination damage funds’ which cover no-fault damages related to vaccination.
COVID-19 vaccine in Belarus – legal aspects
In the context of a rapidly developing pandemic, Belarus also takes part in finding ways of combating COVID-19. So far there is cooperation with Russian scientific institutes on a possible vaccination against COVID-19.
According to the mass media, two Russian COVID-19 vaccines have obtained marketing authorisation in Russia. As to the first one, 100 Belarusian volunteers took part in clinical trials. The press service of the Ministry of Healthcare reports that mass vaccination of the population may begin in mid-2021. Moreover, there is also news that Belarus may begin production of a COVID-19 vaccine based on Russian technology. As to the second one, the recent news is that trials and production may also take place in Belarus. At the same time, Belarus law does not address topics related to COVID-19 vaccination, such as availability, distribution, mandatory or non-mandatory nature. In the absence of special regulation the general rules may potentially apply in the future. For example, vaccination against different diseases usually takes place in accordance with special lists, namely:
- national immunisation schedule – vaccination is carried out at certain times of life, regardless of the epidemiological situation, to create a specific immunity of the human body to the corresponding infectious diseases;
- the list of preventive vaccinations on epidemic grounds – vaccination is carried out in case particular epidemic grounds occur.
COVID-19 is still not included in these lists. There is also no specific liability for damages caused by COVID-19 vaccination. Moreover, 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 (e.g., treatment costs, additional nutrition, pharmaceuticals purchased, nursing care, health resort treatment). As to the groups for vaccination, the official state position is that, first of all, healthcare professionals, teachers and military personnel will be subject to vaccination.
Who will get the vaccine first?
In October the EU Commission presented the key elements to be taken into consideration by the Member States for their COVID-19 vaccination strategies in order to prepare EU citizens for the vaccine when it is available, as well as priority groups to consider for vaccination first. The EU Commission declares that all Member States will have access to COVID-19 vaccines at the same time on the basis of population size.
Member States must ensure:
- easy and affordable access to vaccines for target populations;
- deployment of vaccines with different characteristics and storage and transport needs;
- clear communication on the benefits, risks and importance of COVID-19 vaccines to build public trust.
The EU Communication provides examples of unranked priority groups to be considered by countries once COVID-19 vaccines become available, including:
- healthcare and long-term care facility workers;
- persons over 60 years of age;
- persons whose state of health makes them particularly at risk;
- essential workers;
- persons who cannot socially distance;
- more disadvantaged socio-economic groups.
With regard to the Commission’s recommendations, each Member State should adapt local rules for proper and timely deployment of the vaccine.
In Lithuania, the Ministry of Health has approved an action plan for vaccination. The first task of the plan – supply of the vaccine to Lithuania and its proper storage ‒ has been entrusted to the Health Emergency Situations Centre. There is no publicly available information with regard to priority groups to access the vaccine, terms of reimbursement, etc. Only one thing is clear, though – currently there is no compulsory vaccination in Lithuania.
It is also worth mentioning that as of May 2021 new regulation will enter into effect which will allow vaccination in pharmacies by authorised pharmacists. This new regulation is expected to contribute to smooth COVID-19 vaccination, reduce the workload of healthcare institutions and improve accessibility to vaccines.
In Latvia vaccination against COVID-19 is expected to begin during January 2021. While according to public information from the Ministry of Health the expected costs of a national scale vaccination programme are expected to be around EUR 26.7 million, a wide range of uncertainties remain regarding the organisation of vaccination and delivery of the vaccine itself.
According to information from the Prime Minister after the Cabinet of Ministers meeting on 1 December 2020, vaccines are to be provided free of charge to all Latvian residents. However, the vaccine will first be provided for some groups of the public with priority. According to the Ministry of Health these groups include healthcare and social care sector employees, social care institution clients and persons aged 60 and above.
Although according to information provided by the Prime Minister during a television interview on 2 December 2020, up to 75% of population of Latvia should be vaccinated in order for the programme to be effective, there is no information that the vaccination would be mandatory. The legal provisions on vaccination in Latvia are in Cabinet Regulation No. 330 “Vaccination Regulations”. However, there are currently no indications as to amending the legislative processes in this regard.
In Estonia, there is not yet an official plan for vaccination against COVID-19. The Minister of Social Affairs has publicly indicated that the initial plan foresees vaccination of health care workers, care home residents, people with chronic diseases and people aged 70 and over.
Can employees be required to vaccinate themselves against COVID-19 in Estonia? Although a national immunization plan is in place in Estonia, vaccination is not mandatory. According to currently available information, this will be also the case with regard to the COVID-19 vaccine. So, although requiring vaccination against COVID-19 might seem an easy and effective option to ensure workplace safety, imposing a general vaccination obligation on employees as a precondition for returning to the workplace is not an option. At the same time employers are themselves obliged to provide employees with the possibility to get vaccinated. Read the whole article
NEW PHARMACEUTICAL STRATEGY FOR EUROPE
On 25 November 2020, the European Commission adopted the ‘Pharmaceutical Strategy for Europe’ which promises to influence and shape the life-sciences and healthcare sector significantly in the coming years. In her 2020 State of the Union speech, the President of the European Commission, Ursula von der Leyen, set out the aim of building a European Health Union and according to the (now adopted) Strategy, the Strategy itself will be a key pillar of the European Commission’s vision of building a stronger European Health Union.
The main issue targeted with the Strategy is that although great progress has been made on human health in the European Union in recent years, and innovation is booming, many patients still do not benefit from that innovation because medicines are either unaffordable or unavailable. In order to tackle those issues, the Strategy sets out four work strands, each containing flagship initiatives and flanking measures to ensure the objectives deliver tangible results.
The most important flagship initiatives foreseen by the Strategy which may have a substantive effect on the healthcare systems in the Baltics, are:
- a proposal to revise legislation on medicines for children and rare diseases to improve the therapeutic landscape and address unmet needs (e.g. in paediatric cancer) through more tailored incentives – 2022;
- a proposal to revise pharmaceutical legislation addressing aspects that impede the competitive functioning of the markets and to take account of market effects impacting on affordability – 2022;
- develop cooperation in a group of competent authorities, based on mutual learning and best-practice exchange on pricing, payment and procurement policies, to improve the affordability and cost-effectiveness of medicines and health system sustainability, including cancer treatment – 2021-2024;
- by 2025 establish an interoperable data access infrastructure for European Health Data Space in order to facilitate secure cross-border analysis of health data; tested in 2021 with a pilot project involving EMA and national authorities – 2021 – 2025;
- to support public-private and public-public partnerships financially and technically, e.g. through the Innovative Health Initiative, with particular attention to SMEs, academia, not-for-profit organisations, and through health care systems transformation partnerships – 2021.
We look forward to implementation of the Strategy, especially since the Baltics are among the last EU countries when it comes to the availability of medicines for rare diseases.
Estonia: Three Estonian online pharmacies found in breach of data protection requirements
Three pharmacy chains operating online pharmacies under the brand names Apotheka, Südameapteek and Azeta were recently given one day to bring their practices into compliance with data protection rules or otherwise be subject to a coercive penalty of EUR 100,000 each.
The Estonian Data Protection Authority issued a precept-warning on November 30, 2020 after inspecting the webpages of the three online pharmacies and discovering that these enabled access to valid prescriptions of persons without their consent or any other legal grounds.
Estonian law allows a person to purchase prescription medicines for someone else provided that the person making the purchase knows the personal identification code of the person for whom the prescription has been issued. Normally, when this is done over the counter at a physical pharmacy, the purchase process is restricted only to communicating the relevant information to the pharmacist and making the purchase.
However, during its inspection of the online pharmacies webpages, the Estonian Data Protection Authority discovered that when choosing the option to purchase prescription medicines for another person in the chat windows of these webpages and entering the personal identification code of the other person it was possible to see the valid prescriptions of the owner of that personal identification code.
This means that the online pharmacies disclosed health data to third persons without any legal ground and without checking whether those third persons have legal grounds to access such data.
Health data is special category data that due to its sensitive nature is subject to a higher level of protection, including technical and organisational measures that ensure a level of security that is appropriate to the risk involved. In case of unauthorised disclosure of health data the risks are high and harm done can be irreparable.
This case is a good example of how important it is to follow the concept of privacy by design, as well as the obligation to carry out appropriate privacy impact assessments when designing information technology solutions that involve also processing health data in order to avoid any unexpected risks.
Lithuania: New regulation adopted for remote healthcare services
Legislation on provision of remote healthcare services (HCS), both doctor-to-patient and doctor-to-doctor, has been adopted by the Ministry of Health. The most important terms of the new legislation are as follows:
- HCS may be via physicians providing primary, secondary and/or tertiary outpatient services, dentists, psychiatrists;
- the legislation establishes the types of patients’ inquiries (e.g. cases of infectious diseases) when remote HCS can be provided; however, remote HCS may be provided in all cases when such services can be provided without the patient having direct contact with the physician. This means that a wide range of HCS may be provided;
- before remote HCS are provided, the physician would always assess the possibilities to do so;
- remote HCS would include various services, e.g. assessment of the patient’s state of health, appointment of diagnostic and/or therapeutic services and procedures, other activities necessary for provision of HCS;
- the cost of remote HCS would be covered by the compulsory health insurance fund;
- video or audio recording of remote HCS would be prohibited;
- remote HCS providers would adopt certain procedures and rules on, e.g., registering and identifying the patient, the requirements for remote HCS facilities and their proper use.
The new regulations will come into force on 1 January 2021. Currently, provision of remote HCS is regulated by laws related to the COVID-19 pandemic. The proposed draft legislation provides more flexible terms (e.g. remote HCS may be provided by dentists).
Belarus: New edition of the Law on Pharmaceuticals in force
The new edition of the Law on Pharmaceuticals entered into force on 20 November 2020. It does not cover COVID-19 related matters, but provides for a range of changes in the field of pharmaceuticals circulation. For example, the new edition provides for conditional state registration of pharmaceuticals. To qualify for this procedure, pharmaceuticals should be: original, aimed at treatment, medical preventive care or diagnostics of life-threatening or serious and rare diseases; and there should be no other effective methods of medical care. Also, import of pharmaceuticals without marketing authorisation is now allowed to ensure early access of patients to new methods of treatment.
The new edition contains adjusted terminology, e.g., “preclinical (nonclinical) trial”, “pharmaceutical quality”, “orphan disease”. In addition, the rules of the EAEU Good Pharmaceutical Practices replace the rules of relevant Belarusian national practices.
The new edition of the Law on Pharmaceuticals provides for and reflects the changes which have gradually appeared since the beginning of 2020. Also, it is aimed at harmonisation with the rules of the Eurasian Economic Union.
Although it is not yet clear how effective the innovations will be in the light of the new edition, it can already be assumed that new laws and regulations will be adopted to implement the new rules.