Decree-Law 36/2021, which amends Decree-Law 176/2006 of 30 August ("Medicines Statute"), was published on 19 May. The new Decree-Law introduces a ban on the advertising of discounts on the price of medicines subject to medical prescription that are reimbursed by the National Health Service ("NHS") or that contain narcotic or psychotropic substances.
Therefore, in addition to the rules of the Medicines Statute
already in force that ban the advertising of these types of
medicines, advertising discounts on the price of medicines whose
advertising was already prohibited is now also banned.
In terms of the scope of the ban now established, the
advertising of medicines is considered to be any form of
information, marketing or incentive intended to promote the
prescription, dispensing, sale, acquisition or consumption of
medicines, aimed at the general public, wholesale distributors and
health professionals.
This Decree-Law expressly prohibits "any form of
advertising", regardless of the medium used, and it covers
both generic and specific advertising of discounts on the price of
the medicines referred to.
The ban has been introduced for two fundamental reasons:
firstly, to protect public health and, secondly, due to the
repercussions the discounts may have on equal access to medicinal
products by the general public.
"In addition to the rules of the Medicines Statute
already in force, advertising discounts on the price
of medicines whose advertising was already prohibited
is now also banned."
"The great challenge for pharmacies will be to
harmonise the ban now introduced and the information obligations.
We expect that questions will arise
as to the simultaneous application of these
rules."
When it comes to protecting public health, it is understood
that discounts on medicinal products may be an incentive to
inappropriate consumption rather than rational, safe and effective
use of medicinal products. Naturally, the inappropriate
consumption of medicinal products may have harmful effects on
patients' health. Furthermore, when it comes to access, it is
argued that discounts on these medicines are likely to foster
inequality of access for different groups. This depends on whether
they live in more populated areas, where there is more competition
between pharmacies, or less densely populated ones where there
is less competition. This also has a negative impact on the
economic situation of smaller pharmacies or those located in less
densely populated areas.
Nevertheless, the duty of pharmacies to display relevant
information in the relationship with users remains in force,
particularly regarding the discounts they offer on the price of
medicines, under article 28(1)(d) of Decree-Law 307/2007 of 31
August. This is perhaps the most complex issue resulting from the
obligations introduced by Decree-Law 36/2021. On the one hand, any
form of advertising of prescription-only medicines reimbursed
by the NHS or containing narcotic or psychotropic substances is now
banned. At the same time, the provisions of article 28 of
Decree-Law 307/2007 on information obligations must be
complied with, specifically as regards discounts on the price of
medicines.
The great challenge for pharmacies will be to harmonise the
ban now introduced on advertising the medicines in question and the
information obligations. We expect that questions will arise as to
the simultaneous application of these rules.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.