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Prevention Of Corruption And Protection Of Whistleblowers – White Collar Crime, Anti-Corruption & Fraud

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Impact on the activity of the pharmaceutical
industry

This legal framework is applicable to companies with their
registered office in Portugal and to branches in Portugal of
companies with their registered office abroad, which employ 50 or
more employees.

At the end of 2021, two laws were published to regulate the
general framework for the prevention of corruption in the activity
of companies: (i) Decree-Law 109-E/2021 of 9 December, which
establishes the general rules for the prevention of corruption
(“RGPC”) and (ii) Law 93/2021 of 20 December, which
creates rules to protect whistleblowers (“RJPDI”).

This legal framework is applicable to companies with their
registered office in Portugal and to branches in Portugal of
companies with their registered office abroad, which employ 50 or
more employees.

For the purposes of applying the RGPC, “corruption and
related offences” are understood to mean the offences of
corruption, undue receipt and offer of advantage, embezzlement,
unlawful economic participation in a transaction, extortion, abuse
of power, misappropriation, influence peddling, laundering or fraud
in obtaining or diverting a subsidy, grant or credit as provided
for in the Criminal Code.

In turn, the RJPDI is intended to encourage the reporting of (i)
breaches of European Union rules or national rules that transpose
or implement these rules, (ii) acts or omissions contrary to and
detrimental to the financial interests of the European Union and
European and national rules to prevent and combat fraud, (iii) acts
or omissions contrary to the rules of the internal market and the
free movement of goods, persons, services and capital, including
competition and state aid rules as well as rules on corporate
taxation (iv) acts considered to constitute violent crime,
especially violent and highly organised crime, as well as crimes
committed in the context of organised and economic-financial crime,
and (v) acts or omissions contrary to the European Union rules
applicable to works contracts, supply contracts and service
contracts by contracting authorities or contracting entities in the
fields of defence and security, or contrary to the aims of those
rules.

The RGPC entered into force on 8 June 2022. In the case of
medium-sized companies (companies employing up to 250 people whose
annual turnover does not exceed €50 million or whose annual
balance sheet total does not exceed €43 million) the
implementation of the measures imposed by the new legislation must
take place by 8 June 2023.

The implementation of a whistleblowing channel became mandatory
as of 18 June 2022.

1. OBLIGATIONS OF COMPANIES

Under the new legislation, companies must implement the
following measures:

  • A plan to prevent risks of corruption and related
    offences;

  • A code of conduct;

  • Creation of an extraordinary training plan;

  • A whistleblowing channel;

  • Appointment of a compliance officer;

2. PENALTIES

Both approved laws establish a system of administrative offences
associated with non-compliance with the obligations defined in
them.

In the case of the RGPC, non-compliance with the obligations set
out in it is punishable by a fine ranging from €1000.00 to
€44,891.81.

Non-compliance with the requirements of the RJPDI constitutes an
administrative offence, punishable with a fine of between €
1000.00 and € 250,000.

3. IMPACT ON THE ACTIVITY OF THE PHARMACEUTICAL INDUSTRY

Considering the extensive regulatory framework applicable to
companies in the pharmaceutical industry, many already have
internal regulations aimed at preventing the occurrence of
situations that may potentially correspond to illegal acts covered
by the legal framework now in force.

Transparency in the relationships within the pharmaceutical
industry has been one of the most regulated aspects of the sector
and this contributes to minimising the occurrence of situations
that may correspond to illegal acts of corruption.

A implementação de um canal de denúncias
passou a ser obrigatória a partir do dia 18 de junho de
2022.

Where internal instruments on transparency and the
prevention of corruption already exist, it is important to ensure
that these instruments are adapted to the requirements of the new
legal framework.

Nevertheless, where internal instruments on transparency and the
prevention of corruption already exist, it is important to ensure
that these instruments are adapted to the requirements of the new
legal framework.

The Codes of Conduct and Ethics of the pharmaceutical industry
business associations (for example, at national level, the Codes of
APIFARMA, APORMED, or at international level, those of the EFPIA or
MedTech) already contain extensive regulations on the transparency
of the pharmaceutical industry’s relationships. These
regulations are in line with the national and European system of
penalties in these matters and many of the pharmaceutical industry
companies’ internal transparency instruments are based on these
codes. However, the RGPC requires companies to go further in the
range of measures they have to put into place. It requires them to
implement the preventive measures defined in the RGPC in accordance
with the requirements set out there.

One should also bear in mind that the national penalty arrangements
applicable to the pharmaceutical industry are primarily of the
nature of administrative offences, even though certain offences
with criminal relevance are subject to penalties at this level.
Bearing this in mind, there is a need to review the internal
instruments of companies to ensure not only the mention of criminal
offences of corruption and related offences as provided for in the
Criminal Code in those instruments, as required by the RGPC, but
also the inclusion of the remaining measures and requirements
specifically defined by the RGPC.

A further important point regarding the impact of the RGPC on
public tenders is the need to submit a plan for the prevention of
corruption and related offences by the contractor in cases where
the value of the contract to be entered into makes it subject to
prior supervision by the Court of Auditors, unless it is a natural
person or a micro, small or medium-sized enterprise, certified as
such under the terms of the law.

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.

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