Coronavirus -also known as COVID-19- outbreak which has occurred in Wuhan in China, has been and keeps affecting the daily life of the people worldwide, along with the practices in the Healthcare sector. Due to the COVID-19 pandemic and the agglomeration in the hospitals and healthcare facilities, it causes difficulties for the healthcare professionals and creates urgent need for certain equipment, supplies, and products.
Under such circumstances, health institutions/organizations and healthcare professionals make requests to marketing authorization (“MA”) holders for in-kind/cash donations, with the intent of ameliorating their conditions for handling the current situation that occurred due to COVID-19. Turkish Medicines and Medical Devices Agency (“TMMDA”) has evaluated the nature of such requests that was conveyed through the Associations/Unions of which the MA holders are members.
In this regard, TMMDA has published a circular on April 28, 2020, on its official website, concerning the donations to be made by MA Holders and/or Associations/Unions to which they are affiliated in the context of COVID-19 outbreak, along with a ‘List of Donable Materials.’
As per the Article 6/10 of the Regulation on the Promotional Activities of Human Medicinal Products, “MA Holders can make donations to public health institutions and organizations and non-profit health institutions, establishments and organizations, provided that they comply with the requirements set forth in the relevant legislation.’
Within the circular, TMMDA provides the list of the following equipment as the List of Donable Materials:
Abeslang (Abaise langue)
Bone
Gloves (nonsterile, sterile, powdered, powderless, bag)
Galosh
Surgical mask
Air valve masks (ffp2, ffp3, n95)
Helmet mask
Protective glasses
Protective bag
Face supports
Apron, patient isolation apron
Closed hospital shoes
Protective boot
Disinfectants (fountain system that can be used without touch)
Hand antiseptics (pocket, literal)
Cologne (at least 70 °, pocket size, literry)
Paper towels
Liquid soap
Baticon
Hand cream (pocket size)
Disposable examination table cover
Swab (in standards to be used for sampling)
Laboratory materials (pipet, tube, Eppendorf)
Pulse oximeter
Contactless thermometers
Tension tool
UV lamp
Glass cabin for intubation
Sample reception cabin
Patient chart board
Waste box (can be used without touch)
Laundry machine/laundry drying machine
Human medical products (with approval of the institution to be taken)
TMMDA stipulates that only the above-mentioned materials can be donated by the MA Holders and in accordance with the conditions stipulated under the Regulation on the Promotional Activities of Human Medicinal Products. It is also required that;
All products to be donated, product packaging and/or transport boxes shall only bear the name and/or logo of the MA holder and/or unions/associations of which the MA holders are members,
The name of the medicinal product shall not appear on the products to be donated, on product packaging and/or transport boxes,
Donations shall not be made to healthcare professionals on an individual basis via visit, courier, cargo, etc.,
Distribution of materials shall be made to the facilities providing health services (public/university/private/foundation hospital, laboratory, pharmacy, family health center) in line with the direction of the Provincial Health Directorates to be provided upon application,
The list of requirements shall not be collected or distribution shall not be made via visits of product promotion representatives,
All donations made shall be notified to TMMDA as a ‘transfer of value’ duly and in compliance with the Regulation on the Promotional Activities of Human Medicinal Products.
For the medicinal products intended to be donated by MA Holders and/or the associations/unions to which the MA Holders are affiliated, a separate application must be made to TMMDA, and permission must be obtained.
The stakeholders may expect further adjustments and clarifications from health authorities in order to meet the emerging or increasing needs in the health sector as long as COVID-19 effect continues.
Published on Lexology.com on 05.05.2020.