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January/2017 |
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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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Technology and the
importance of data protection in the health
sector
Clinical trial liability
insurance
Regulatory Notes
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Technology and the importance of
data protection in the health sector |
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Fábio Pereira &
Adriana Rollo |
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In recent
years, we have observed a significant
increase in the use of information
technology in the area of health services.
These instruments that serve as support to
the medical practice not only have the
potential to make the activity in this field
more efficient, but also contribute to the
development of better public health
policies. In contrast, these innovations
also entail a number of risks related to the
privacy of patients and the protection of
their personal data.
Although there is a set of general rules
that sparsely protects privacy rights and
personal data in Brazil, there is still no
specific law to protect sensitive data and
“protected health information” (PHI)
contained in patient records, nor is there
any definition of what can be considered
"sensitive data", so that this matter is
only handled in codes of ethics and best
practices guides. Concerning privacy, this
legislative gap can put patients in an
unsettling situation, which is especially
serious due to the sensitivity of the
information being circulated.
In 2007, the Brazilian Federal Medical
Council issued Resolution No. 1,821/07,
which regulates the replacement of the
physical files of patients’ medical charts
for a digital medical record, which is also
being used, by analogy, to regulate other
issues related to the storage and sharing of
patient information. Said Resolution
determines that the data contained in the
medical charts may only be disclosed after
obtaining the patient’s authorization, or
due to just cause or legal duty, and
establishes security requirements for the
computer system that processes the digital
files.
Due to the volume of information that is
collected and the lack of intercommunication
between the databases, it has become
impossible to obtain the consent from all
patients, which would be fundamental in
order to legally store and share the
information. For this reason, patient data
processing started to be performed through
the "anonymization of data," i.e. data that
could not identify a patient, but that can
be used to generate statistics and create
strategies beneficial to the health sector,
both by the private sector and by the
authorities responsible for the development
of public policies.
Even after the implementation of anonymized
data processing, it is worth mentioning that
the information circulating in the
healthcare area continues to be considered
very sensitive, and the protection of such
data is extremely relevant.
An increasingly computerized and
technological environment necessarily
exposes its databases and systems to
cyber-attack threats. Sensitive data and PHI
from patient records can be extremely
valuable to hackers, because they may
contain, as we have seen, a plethora of
personal information, including names,
addresses, dates of birth, social security
numbers, license numbers and health plans
numbers, which can all be sold to fraudsters
who work on the Deep Web, a layer of the
Internet where cybercriminals conduct their
business.
Currently in Brazil, Bill of Law No.
5,276/2016 is under discussion in Congress
and, if approved, will discipline the
processing of personal data, establishing
specific obligations regarding data
protection and penalties in case of
noncompliance. The Bill classifies medical
information as "sensitive data", a category
of personal information that shall receive a
higher degree of protection. Meanwhile, this
matter shall be analyzed in lieu of the
Federal Constitution, de Consumer Defense
Code, Law No. 12.965/14, known as the
Brazilian Internet Act, and Decree No.
8.771/2016, which regulates it, whenever
data transits within the digital or virtual
environment.
Given this scenario that culminates in the
constant modernization of the health sector
in Brazil - as it can be seen from the
implementation of digital systems and
massive databases such as DATASUS - it is
important to rethink how we can reconcile
technological innovation with the rights and
guarantees of patients, such as the
confidentiality of their information and the
privacy of their data. |
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Clinical trial liability insurance |
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Andrea Piccolo
Brandão |
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The insurance market
is constantly developing and creating new
products aiming to offer protection to new
identified risks. In this scenario, the
clinical trial liability insurance has
emerged to attend a specific claim of the
pharmaceutical industry, which is repair
damages caused to patients that voluntarily
participate in clinical trials and,
consequently, minimize the risks to which
laboratories and other institutions
dedicated to the development of new
medication are exposed to.
Lately, the request and sale of such type of
insurance has considerably increased due to
the issuance of Resolution No. 466/2012 and,
especially, of ANIVISA’s RDC No. 09/2015.
The previous one (Resolution No. 466/2012),
which updated Resolution No. 196/1996,
establishes that researchers, sponsors and
institutions and/or organizations involved
in different stages of the research shall
provide full assistance and indemnify any
clinical trial’s participant injured as a
result of such research, including adverse
reactions specified or not in the Consent
Clarification Term. The later resolution,
RDC 09/2015, regulates the performance of
clinical trials in Brazil.
In short, the clinical trial liability
insurance covers losses to which insured
people may become liable for, as consequence
of injuries caused to third-parties, i.e.
clinical trial participants. Its main
difference when compared to the general
liability insurance that is normally hired
by pharmaceutical industries is the coverage
of damages and other consequences arisen
from medication still subject to tests and,
therefore, not yet registered. The main
purpose of this insurance is to mitigate the
existing risks during the clinical trial
period and to encourage patients to
volunteer.
Usually, the most common insured parties in
those policies are the sponsors, researchers
or promoters of such clinical trials.
Nevertheless, other parties can also figure
as insured, such as, for example, the
logistics company that transports the
medication.
Among the main coverage offered, it is
common to find: (i) the already mentioned
personal damages caused to clinical trial’s
participants due to unforeseen or specified
reactions mentioned in the research
protocol; (ii) defense costs; and (iii)
medical expertise costs.
The amounts to be covered/reimbursed shall
respect the limits of insurance and shall be
defined by a judicial verdict, final
administrative decision when it is
understood by the insurer that a judicial
remedy is irrelevant, final arbitral
decision or final judicial or extrajudicial
agreement, as long as with the prior and
express consent of the insurance company.
Currently, three insurance companies have
offered the product in Brazil and, the most
claimed coverage regards medical expenses. |
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Regulatory Notes |
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Ana Luci Grizzi, Maria Paula Ribeiro
Carreteiro & Julia Filipini Ferreira |
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New deadlines for the analysis of requests
for drugs’ registrations and post
registration changes
On December 29, 2016, Law No. 13.411/2016
(“Law 13.411/2016”) was enacted. Law
13.411/2016 amends Law No. 6.360/1976 (which
governs drugs, pharmaceutical raw materials,
cosmetics, sanitizers, among others products
subject to sanitary surveillance), and Law
No. 9.782/1999 (which established the
Federal Health Regulatory System and created
the Federal Health Regulatory Agency -
“ANVISA”).
Among the changes introduced by Law
13.411/2016, we highlight:
- New
deadlines for the analysis of requests
for drugs’ registrations and post
registration changes;
- New
deadline for filling administrative appeals
before ANVISA; and
- Changes in the specifications of the
management agreement (mechanism to evaluate
ANVISA’s administrative performance).
Law
13.411/2016, which aims at reducing ANVISA
administrative proceedings’ bureaucracy, not
only set forth deadlines for the analysis of
requests for product registration and for
appeals, but also provided for penalties in
case of non-compliance with such deadlines. |
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Conformity for the use of active
pharmaceutical raw materials
On December 13, 2016, ANVISA published
Ordinance No. 14/2016 (“Ordinance 14/2016”)
which provides for the conformity for the
use of active pharmaceutical raw materials,
listed in Ordinance No. 03/2013.
Ordinance 14/2016 authorizes active
pharmaceutical raw materials to be produced,
imported, used in the manufacture of medical
products and commercialized, as long as its
registration has been approved or the
request for registration has been duly filed
with the complete documentation requested by
Resolution No. 57 of November 17, 2009.
Please note that simple filing for a
registration request will not authorize the
production, import, use in the manufacture
of medical products and commercialization in
circumstances where the registration of such
active pharmaceutical raw material has been
previously denied. In such cases, proper
registration or registration exemption
issued ANVISA’s will be required. |
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Adjustment in medical products pricing
On December
20, 2016, the Provisional Measure No.
754/2016 was published (“PM 754/2016”). PM
754/2016 amends Law No. 10.742/2003 which
sets forth the pharmaceutical sector
regulation and creates the Chamber for
Regulation of the Medical Products Market (Câmara
de Regulação do Mercado de Medicamentos
– CMED). PM 754/2016 sets forth that, on
exceptional character, CMED’ Ministry
Council may authorize positive or negative
adjustments of drug prices. |
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ANVISA’s Public Consultation No. 273/2016 –
Proposal for a new rule concerning
outsourcing of manufacturing steps
The Federal Health Regulatory Agency
(“ANVISA”) has published the Public
Consultation No. 273, of November 10, 2016,
to discuss the possible issuance of a new
rule regarding outsourcing of manufacturing
steps, quality control and storage of drugs,
matters currently governed by ANVISA’s
Resolution RDC 25/2007.
Among the topics subject to discussion in
the context of the Public Consultation, we
highlight:
- The
definition of responsibilities and
duties that must be part of the
outsourcing agreement;
- The
definition of the outsourcing specific
conditions;
- The
hypothesis of outsourcing of manufacturing
steps, quality control and storage; and
- The draft Notification to ANVISA
regarding the outsourcing.
Initially a
30-day period was granted for the public to
present comments and suggestions.
Thereafter, such term was then extended
until February 7, 2016.
ANVISA has justified the Public Consultation
as necessary to make the rule clearer and
more specific as regards the situations in
which outsourcing is permitted and which
situations must be considered
filing-mandatory according to the
registration and post registration rules;
need for import companies to perform
analysis in own quality control labs and
inclusion of section setting forth that the
contracted party’s facility must own the
Good Distribution and Storage Practices
Certificate valid during the term of the
relevant outsourcing agreement. |
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New ANVISA rule regarding labeling of
products for SUS
On December
6, 2016 ANVISA published Resolution No. 131
(“RDC 131/2016”) which regulates the
inclusion of a disclaimer in the labeling of
personal hygiene products, cosmetics and
perfumes aimed to governmental programs
associated to the Unified Healthcare System
(“SUS”). As from said date, there is the
option to include the expression “MINISTRY
OF HEALTH – MAY NOT BE SOLD IN THE MARKET”
(“MINISTÉRIO DA SAÚDE - VENDA PROIBIDA AO
COMÉRCIO”, in Portuguese) on the labels of
primary and secondary packages of personal
hygiene products, cosmetics and perfumes
designed to governmental programs associated
to the SUS, regardless of a request for
change in the labeling in the process of
product regularization with ANVISA, provided
that there are no changes to the mandatory
disclaimers of the label. |
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