Sponsored briefing: Actions Taken by the Ministry of Health and the Turkish Pharmaceutical and Medical Device Institution in relation to COVID-19

Sponsored briefing: Actions Taken by the Ministry of Health and the Turkish Pharmaceutical and Medical Device Institution in relation to COVID-19

Dear Colleagues, Clients and Friends,

Coronavirus (COVID-19), which has been declared a ‘pandemic’ by the World Health Organisation first emerged in Wuhan, China on 31 December 2019, and rapidly became a major topic by spreading across the globe. The first case in Turkey was seen on 11 March 2020, following which the Ministry of Health (the Ministry) and the Turkish Pharmaceutical and Medical Device Institution (the Institution) have taken various actions and steps to prevent the spread of the virus, protect the public health and ensure the market order. Some of the significant actions taken to date are as follows:

Restrictions on promotional activities. According to the Institution’s announcement dated 19 March 2020, visits paid by product promotion representatives to all health institutions and organisations including pharmacies, doctors, dentists and pharmacists have been suspended until a further announcement. However, within this period, product promotion representatives can carry out promotional activities electronically (via e-mail or video conference).

Export licence requirement for medicinal products used against COVID-19. As per the ‘Communiqué Amending the Communiqué Regarding Products Subject to Export Prohibition and Pre-Authorization (Export:96/31)’ published in the Official Gazette numbered 31058 dated 4 March 2020, export of protective masks (masks with gas, dust and radioactive dust filter), jump suits (protective work-clothes), liquid-proof aprons (protective aprons used against chemicals), goggles (protective goggles) supplied to the market within the scope of the Regulation on Personal Protective Equipment; as well as medical and surgery masks, and medical sterilised/ non-sterilised gloves supplied to the market within the scope of the Regulation on Medical Devices became subject to the pre-authorisation of the Institution. Additionally, under the Amending Communiqué published in the Official Gazette numbered 31080 dated 26 March 2020, ventilators, oxygen concentrators, ventilation consumables, patient circuits, cannulas, intubation tubes and intensive care monitors have also been made subject to export pre-authorisation. Information and documents required for obtaining export authorisation from the Institution of the relevant products are indicated in the announcements of the Institution dated 5 March 2020 and 6 March 2020. On the other hand, no authorisation is required for products, export declarations of which have been registered with the relevant Ministry before 4 March 2020.

Temporary licence to produce disinfectants. Pursuant to the Circular numbered 2020/1 dated 19 March 2020, which regulates the procedures and principles regarding processes and operations related to biocidal products that are in direct contact with the human body, a temporary licence may be issued for a period of three months whereby pharmacies can be allowed to produce hand sanitisers using the formula determined by the Institution, for purposes of meeting the need for disinfectants due to the state of emergency caused by the COVID-19 outbreak.

Measures regarding clinical research. Measures to be applied to clinical research in connection with COVID-19 have been determined with the announcement dated 20 March 2020. Firstly, sponsors have been reminded of the need to regularly conduct risk assessments by observing priorities and urgencies due to COVID-19 and to carry out and update research organisations on this basis. In terms of such risk assessments; protection of the safety of volunteers, reducing the workload of research centres and ensuring compliance with social isolation rules are essential. Pursuant to the regulation: (i) clinical researches may be temporarily suspended or terminated early if deemed necessary considering the nature of the research; (ii) in cases giving rise to safety concerns, emergency safety measures can be implemented without being subject to the approval of the ethics committee and the Institution; (iii) in case of deviation/breach of the protocol due to COVID-19 measures, such deviation or breach will not be required to be notified to the ethics committee and the Institution; (iv) postponing or re-scheduling of monitoring of clinical research will be the initial preference, but in case continuing of such monitoring activity is necessary due to the nature of the research, then timing of the visits will be coordinated with the research centre; (v) if monitoring at the research centre is not possible due to circumstances such as quarantine or isolation, clinical research may be remotely monitored in accordance with the Law on Protection of Personal Data and confidentiality principles applicable to clinical research; (vi) products subject to clinical research may be stocked up more than usual in order to ensure the sufficient amount of stock due to any potential quarantine or customs restrictions; (vii) research meetings will only be held online within this period; and (viii) training and meetings regarding good clinical practices and clinical research to be held face to face will not be allowed.

Postponement of scientific organisations. Based on the Circular numbered 2020/3 published in the Official Gazette numbered 31074 dated 20 March 2020, all national and international scientific, cultural, artistic and similar meetings or organisations to be held at open or closed spaces have been postponed until the end of April 2020.

Please do not hesitate to contact us for any further information on this briefing.

Elvan Aziz
Partner
eaziz@paksoy.av.tr

Nihan Bacanak
Counsel
nbacanak@paksoy.av.tr

Can Yasin Aksoy
Associate
caksoy@paksoy.av.tr

This briefing is for information purposes; it is not legal advice. If you have questions, please call us. All rights are reserved.

Paksoy is an independent full-service law firm in Istanbul, Turkey focused on helping clients in a wide range of legal areas including cross-border investments, acquisitions, international business transactions, banking and finance, projects, infrastructure, investigations, compliance, disputes, litigation and arbitration.

Paksoy Orjin Maslak Eski Büyükdere Cad. No:27 K:11 Maslak 34485 İstanbul

www.paksoy.av.tr

Sponsored briefing: The Effects of Coronavirus (Covid-19) on Turkish Litigation Practice

Sponsored briefing: The Effects of Coronavirus (Covid-19) on Turkish Litigation Practice

Dear Colleagues and Friends,

The outbreak of the novel coronavirus (Covid-19) has affected almost all individuals and businesses in Turkey with over 3,629 confirmed cases, as of 26 March 2020, in all of Turkey. Continue reading “Sponsored briefing: The Effects of Coronavirus (Covid-19) on Turkish Litigation Practice”

Sponsored briefing: Turkey | Data protection during the COVID-19 pandemic

Sponsored briefing: Turkey | Data protection during the COVID-19 pandemic

Dear Clients, Colleagues and Friends,

Following the announcement of the COVID-19 pandemic by the World Health Organization, increasingly restrictive measures to curb the spread of the virus have been taken in Turkey, as in many other countries all over the world. These measures lead to additional personal data processing activities, and raise new challenges in terms of compliance with data protection law. Continue reading “Sponsored briefing: Turkey | Data protection during the COVID-19 pandemic”

For the profession, as the world, the coronavirus is a moment of truth

For the profession, as the world, the coronavirus is a moment of truth

The longer you do this job, the more your mind wanders to the big moments – recessions, terrorist attacks, political shocks, wars. Yet as I sit here typing this leader in a near-deserted London office, the majority of our team working from home as we try to put this issue to bed, it is a struggle to recall anything that compares to the coronavirus pandemic spreading through the world.

We face unprecedented times – hyperbole typically flung around with abandon until you realise with shock that this time it applies. As I write, London and New York, those famous global cities and the world’s two dominant legal hubs, look within days of total lockdown. Continue reading “For the profession, as the world, the coronavirus is a moment of truth”

Sponsored briefing: Measures taken by the regulatory authorities in the banking sector regarding the Covid-19 outbreak

Sponsored briefing: Measures taken by the regulatory authorities in the banking sector regarding the Covid-19 outbreak

The Banking Regulation and Supervision Agency (the BRSA), the Central Bank of Republic of Turkey (the CBRT) and the Banks’ Association of Turkey (the BAT) have swiftly taken several measures after the declaration of the first confirmed Covid-19 case in Turkey on 11 March 2020 in order to mitigate the outbreak’s impact on the financial markets and soften expected disruptions in commercial activities that may be caused by Covid-19. Such measures are set forth by the relevant regulators in order to provide flexibility to financial institutions (the FIs) to ensure (i) financial stability of the FIs and (ii) meet FIs customers’ needs such as facilitating cash flow of individuals and SMEs which are likely to be the most affected by this outbreak and ultimately to mitigate the macroeconomic effects and risks arising from Covid-19 in financial markets.

Firstly, the BRSA, in its press release dated 16 March 2020, indicated that the business continuity plans prepared routinely by banks in accordance with the Guide on Management of Operational Risks with the aim of continuity of FIs’ activities and limitation of losses which arise from severe business interruptions are re-examined by the BRSA and in this regard all necessary measures are taken. This measure has been taken by the BRSA within the framework of prudent supervision approach. Continue reading “Sponsored briefing: Measures taken by the regulatory authorities in the banking sector regarding the Covid-19 outbreak”

Sponsored briefing: Labour law issues in Covid-19 crisis

Sponsored briefing: Labour law issues in Covid-19 crisis

Upon confirmation of the spread of Covid-19 in Turkey with the declaration of the first case on 11 March 2020 and simultaneously with the World Health Organization’s declaration of COVID-19 as a global pandemic, government started to take certain measures including banning people above the age of 65 from going out; closing down certain workplaces. The measures are actively changing based on the evolution of the pandemic disease, yet, no complete lock down has been announced for many sectors but companies are encouraged to take their own measures during this period. This article mainly focuses on the impact of the Covid-19 pandemic on the employment relationship by presenting possible options provided under the Turkish labour legislation.

It is globally accepted that the Covid-19 pandemic is a force majeure event. However, force majeure provisions provided under the Labour Code (Law No 4857) (published in the Official Gazette dated 10 June 2003 and numbered 25134) (Labour Code) allow parties to terminate the employment relationship under limited circumstances. Continue reading “Sponsored briefing: Labour law issues in Covid-19 crisis”

NRF asks staff to cut working hours by a fifth and defers partner pay in re-introduction of financial crisis-era flexi scheme

NRF asks staff to cut working hours by a fifth and defers partner pay in re-introduction of financial crisis-era flexi scheme

Norton Rose Fulbright (NRF) is asking its staff to agree to a 20% cut of weekly working hours and delaying profit distribution to partners in response to the Covid-19 crisis.

The firm announced today (20 April) it is asking its employees to sign up to a temporary change of their contract for one year from 20 April which will make them eligible to move to 80% of their working hours and base salary. Continue reading “NRF asks staff to cut working hours by a fifth and defers partner pay in re-introduction of financial crisis-era flexi scheme”

Sponsored briefing: How to handle contractual disputes in the COVID-19 era

Sponsored briefing: How to handle contractual disputes in the COVID-19 era

Since the COVID-19 coronavirus was first reported in Wuhan, China in December 2019, strict and unprecedented measures have been gradually imposed by governments around the globe to limit risks of contagion. On 11 March 2020, the severity of the phenomenon was emphasised by the World Health Organization (WHO)’s declaration of COVID-19 as a global pandemic. As circumstances continue to evolve, substantial business and operational disruptions are a cause of great uncertainty that now reigns in various sectors and trade relations around the world. The implications are particularly profound when it comes to performance of contractual obligations in view of COVID-19’s far-reaching socio-economic effects. In this context of a health crisis exacerbated by the unexpected nature of the outbreak, the main issue is whether parties to affected commercial contracts may invoke force majeure as an argument to justify for failure to perform their contractual obligations.

For contracts governed by Turkish law, the first observation to be made is that the concept of force majeure and its defining conditions are not explicitly provided in the Turkish Code of Obligations (TCO) (published in the Official Gazette dated 4 February 2011 and numbered 27836) (Law No. 6098). The Court of Cassation has come to clarify at various occasions what should be understood by force majeure and under which circumstances parties are entitled to rely upon this concept. Within the framework of the case law and legal doctrine, it can be said that force majeure is deemed to arise when a contracting party’s performance is materially affected by (i) an event beyond his reasonable control, (ii) the effects of which could not have been foreseen at the date of commencement of the legal relationship and (iii) avoided despite all appropriate measures being taken. Continue reading “Sponsored briefing: How to handle contractual disputes in the COVID-19 era”

Sponsored briefing: The COVID-19 Handbook – Force majeure and contracts

Sponsored briefing: The COVID-19 Handbook – Force majeure and contracts

The novel coronavirus, now officially known as COVID-19, was first seen in Wuhan, China in December 2019 and continues to spread rapidly worldwide. The World Health Organization (WHO) declared it an ‘epidemic’ first and then a ‘pandemic’ on 11 March 2020.

As COVID-19 cases continue to surge amid crashed markets and overwhelmed healthcare systems, it is also taking a toll on contractual relationships as countries continue to take drastic measures to flatten the curve of the pandemic. These measures include the ordering of curfews, travel bans and state of emergencies, all of which undoubtedly have enormous impacts on businesses and contracts. Continue reading “Sponsored briefing: The COVID-19 Handbook – Force majeure and contracts”

US worst hit as Cadwalader becomes latest firm to respond to Covid-19 with pay cuts

US worst hit as Cadwalader becomes latest firm to respond to Covid-19 with pay cuts

Cadwalader, Wickersham & Taft has become the latest firm to take drastic financial measures as the Covid-19 pandemic reaches new heights suspending partner pay and cutting salaries elsewhere. 

The move comes as the number of confirmed cases of the virus in the US soared to nearly 200,000 today (1 April) and the number of deaths reached 4,000. Cadwalader will stop paying partners, reduce associate salaries by 25% and impose pay cuts of 10% to 25% on staff to mitigate the economic impact of the crisis as it hits businesses around the world.  Continue reading “US worst hit as Cadwalader becomes latest firm to respond to Covid-19 with pay cuts”