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October/2016 |
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HEALTHCARE |
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| Welcome to
the Heathcare Newsletter, a
publication prepared by
our multidisciplinary team dedicated to the
Healthcare industry. |
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In this edition: |
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Remarks about
advertising medicinal products
Brazil and Europe - A
joint declaration to expedite patent
examination
Transfer of product
registration - ANVISA's new rule
The first proceeding for
resolution of repetitive cases in the Santa
Catarina Court of Appeals is about
judicialization of health demands
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Remarks about advertising medicinal
products |
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Adriana Rollo |
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Due to the
public interest underlying the issue of
medicinal products, advertisements of such
products must take into account very
specific features. In Brazil, the
advertisement of medicinal products must
comply with the regulations issued by the
Brazilian Health Surveillance Agency
(ANVISA) and the Consumer Defense Code.
Firstly, it is important to highlight that,
given the possible adverse consequences
resulting from the use of such products, the
advertising of prescription-medicine is
restricted to a specific public: health
professionals licensed to prescribe such
products.
According to ANVISA, medicinal products
shall not be regarded as simple consumer
products or merchandise, but as instruments
in service of health promotion, circulated
in a rational manner, in accordance with
public health policies and sanitary needs of
the country. Medicinal products’
advertisement cannot induce indiscriminate
consumption or encourage self-medication,
considering that each medical product
represents a sanitary risk and even over the
counter medication shall be consumed with
criteria and responsibility.
Additionally, ANVISA highlights the duty of
correctness, clarity and accuracy in the
presentation of medicinal products. In case
the possibility of side effects or
contraindications is verified, they may not
be neglected – the advertisement cannot
suggest to the consumer that the risks are
lower than in reality.
ANVISA’s Resolution No. 102/2000 prohibits
the use of statements such as that a
medication is “safe”, “exempt of secondary
effects or risks of use” or equivalent
expressions. Resolution RDC No. 98/2008 also
prohibited the appearance of celebrities in
advertisements and the broadcasting of
indirect advertising (promotion of a medical
product without direct reference of its
name, for example). Finally, another warning
frequently made by ANVISA relates to the
fact that the advertisement may not be
financial detrimental to consumers due to
the acquisition of an ineffective or
inappropriate product.
It is possible to observe, thus, that the
restrictions mentioned above aim to
remediate the misperception of approaching
medicinal products as simple consumer goods.
They aim at guaranteeing that the value that
advertisements add to the products are in
fact related to the technical
characteristics of the medical product and
not emotional attributes and subjective
valuations, which are recurring in
advertising business in general. Therefore,
the legal framing for the advertisement of
medical products cannot be simply inserted
in the logic of the free market, since in
this context the public interest shall
always prevail over the private interest. |
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Brazil and Europe - A joint
declaration to expedite patent examination |
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Fernando Braune & Sinara Travisani Cardozo |
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The
Minister of Industry, Foreign Trade and
Services (MDIC, initials in Portuguese),
Marcos Pereira, and the Vice President of
the European Patent Office (EPO), Raimund
Lutz, signed on October 17, 2016 in Weimar
(Germany), a joint declaration for the
implementation of a pilot project on work
sharing in patent examination. The Brazilian
PTO (BPTO), along with the MDIC, and EPO
will define the scope of the proposal, which
may follow the lines of the Patent
Prosecution Highway (PPH), including
economic sectors involved, the number of
patents and deadlines.
The project, which is in the pilot phase,
follows the pattern of further cooperation
with the US Patent and Trademark Office
(USPTO), already in place, and the Japanese
Patent Office (JPO), which agreement for the
creation of a working group was signed in
early October. The goal of these
initiatives, all on a trial basis, is
seeking greater agility and quality in the
examination of patent applications. They
will allow Brazilians to use the examination
results from the signatory countries of the
agreements (currently in the United States
and in the future, Japan, and Europe) to
expedite examination in the BPTO.” |
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Transfer of product registration -
ANVISA's new rule |
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Ana Luci Grizzi & Maria Paula de Mello Ribeiro |
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On August
25, 2016, ANVISA published Resolution No.
102, of August 24, 2016 (“RDC 102/2016”),
that among other matters, established new
rules for the transfer of ownership of
registration of products subject to health
regulatory surveillance.
Among the changes introduced by RDC
102/2016, we highlight that:
- The transfer of product registration will be
allowed in commercial transactions (i.e.
purchase and sale), in addition to the
transfers implemented by means of corporate
reorganization, which were already admitted
in the prior regulation;
- The condition for the transfer is the
maintenance of technical specificities and
characteristics of the product;
- The product registration expiration date is
not changed with the transfer;
- The successors or companies that have
acquired assets and that do not hold the
applicable Federal Sanitary License (“AFE”)
and/or the Special License (“AE”) shall
operate based on the AFE/AE of the
succeeded/seller for importation purposes
while a potential request for new AFE/AE is
under review by ANVISA.
Although the new resolution aims to reduce
the bureaucracy for the transfer of product
registration from a regulatory point of
view, other important matters (such as AFE
obtained on specific situations, depletion
of stocks and deadlines for analysis of
requests by ANVISA) have not been clearly
resolved and should be analyzed on a
case-by-case basis.
The RDC 102/2016 revoked RDC No. 22/2010,
which permitted the transfer of product
registration exclusively in certain
pre-established types of corporate
reorganizations (spin-off, incorporation and
merger). |
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The first proceeding for resolution
of repetitive cases in the Santa Catarina
Court of Appeals is about judicialization of
health demands |
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Priscila Sansone, Rebeca Gomes &
Amanda Mattos Rudzit |
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The Public
Law Chambers in the Santa Catarina Court of
Appeals is now ruling its first Proceeding
for Resolution of Repetitive Cases
(“Incidente de Resolução de Demandas
Repetitiva”, or “IRDR”, in Portuguese), to
decide about the need for citizens to prove
low financial conditions as a prerequisite
to access free assistance from the public
health system in Brazil.
The Proceeding for Resolution of Repetitive
Cases is a new mechanism brought by the new
Brazilian Code of Civil Procedure. It aims
at establishing a precedent on issues that
are frequently discussed in courts and
generate a risk of diverging decisions. This
is the case of health demands, which
currently mobilizes more than 25 thousand
proceedings in lower courts and the Court of
Appeals in the state of Santa Catarina.
The Proceeding for Resolution of Repetitive
Cases is one of the means brought by the new
Code of Civil Procedure to grant more legal
certainty and find a solution that
guarantees equal treatment to identical
cases.
The creation of the Proceeding for
Resolution of Repetitive Cases suspends all
cases that debate the same legal matter, in
order to permit that the same solution is
applied to all. The case on the
judicialization of health demands had its
first ruling session on October 26, but was
adjourned until November 9 due to one of the
Justices’ requests to access the case
dockets.
The solution of this case will cause strong
impacts on Brazilian public accounts, which
are currently burdened with the financial
weight of decisions that demand the
government to pay for medication and other
health procedures, many times disregarding
public budget constraints. The case shall
also affect Healthcare and Life Sciences
industries, generating a possible increase
in public demand for medication, as well as
other possible effects in companies’
relations with public organs and
participation in bidding processes with the
public health system in Brazil. |
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