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5/15/2006
Regulation of Marketing Practices
Recent Trends
Linda R. Horton
Partner, Hogan & Hartson LLP
Brussels
EU Pharmaceutical Law Forum
15-16 May 2006
The Renaissance Hotel
Brussels
How to contact me: Linda Horton
•Counsels clients in the pharmaceuticals,
medical devices, food, and animal health
industries on regulatory requirements of the
European Union, the U.S. Food and Drug
Administration (FDA) and regulatory
counterparts elsewhere.
•Recommended in the European Legal 500
for EU regulatory work in the areas of
pharma & biotech and food & drug.
•Focuses on regulatory pathways, EU and
global
•Served as FDA 30+ years as Director of
International Policy; Deputy Chief Counsel
for Regulations; Device/Drug Counselor;
Litigator; Legislative Director
•Extensive experience worldwide and
contacts with regulatory and parliamentary
officials.
Linda R. Horton
Partner
Hogan & Hartson, Brussels
T: +32-2-505-0931
E: [email protected]
Changing regulatory landscape & response
ƒ Relatively few changes in Community code
ƒ Broader changes in national laws, EFPIA code and
national codes
ƒ Heightened attention to marketing practices by
European policymakers; link to drug safety debate
ƒ Stepped-up enforcement actions by European
authorities and code bodies
ƒ U.S. enforcement activities affecting global
operations
ƒ“Building a shield” with a compliance plan
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5/15/2006
The European regulatory framework
The pharmaceutical industry in Europe is subject to
a complex array of EU-level directives, national laws,
and industry codes at the international, regional, and
national levels.
EU Directive 2001/83/EC on the Community code
relating to medicinal products for human use
contains the general regulatory framework
governing the advertising and marketing of
medicines in the European Union.
3
Regulatory oversight comes from multiple
directions
As EU Member States have implemented the
relevant provisions of the Directive and added their
own requirements, pharmaceutical companies have
witnessed increased scrutiny of their marketing
practices.
The regulatory officials and prosecutors cracking
down on marketing practices are not simply (or even
principally) drug regulatory authorities but also local
prosecutors, tax authorities, and anti-bribery
authorities.
This phenomenon is true around the world,
including in Europe, U.S., and China.
4
European Community Legislation
31 March 1992: the Advertising Directive, 92/28
6 November 2001: Directive 2001/83/EC of the
European Parliament and of the Council of on the
Community code relating to medicinal products for
human use, Official Journal L 311 , 28/11/2001 P.
0067 - 0128 (repealed and replaced Advertising
Directive)
30 April, 2004: Directive 2004/27/EC of the European
Parliament and of the Council of 31 March 2004
amending the Community code, Official Journal L
136/34 (effective 30 October 2005
5
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Community Code on Medicinal Products
on Advertising: Article 86
What is "advertising of medicinal products“?
Any form of door-to-door information, canvassing
activity or inducement designed to promote the
prescription, supply, sale or consumption of medicinal
products; it shall include in particular:
- the advertising of medicinal products to the
-
general public,
advertising of medicinal products to persons
qualified to prescribe or supply them,
visits by medical sales representatives to
persons qualified to prescribe medicinal products,
the supply of samples,…
6
Advertising, continued
- the provision of inducements to prescribe or
supply medicinal products by the gift, offer or
promise of any benefit or bonus, whether in
money or in kind, except when their intrinsic
value is minimal,
- sponsorship of promotional meetings attended by
persons qualified to prescribe or supply medicinal
products,
- sponsorship of scientific congresses attended by
persons qualified to prescribe or supply medicinal
products and in particular payment of their
travelling and accommodation expenses in
connection therewith.
7
Advertising: what is not covered by
Community code provisions
2. The following are not covered by this Title:
-
the labelling and the accompanying package leaflets, which
are subject to the provisions of Title V,
-
correspondence, possibly accompanied by material of a nonpromotional nature, needed to answer a specific question
about a particular medicinal product,
-
factual, informative announcements and reference material
relating, for example, to pack changes, adverse-reaction
warnings as part of general drug precautions, trade catalogues
and price lists, provided they include no product claims,
-
information relating to human health or diseases, provided that
there is no reference, even indirect, to medicinal products.
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5/15/2006
Key provisions that have been in place
since 1992
1. Article 87: Member States shall prohibit any
advertising of a medicinal product in respect of
which a marketing authorization has not been
granted in accordance with Community law.
2. All parts of the advertising of a medicinal product
must comply with the particulars listed in the
summary of product characteristics.
3. The advertising of a medicinal product:
-
shall encourage the rational use of the
medicinal product, by presenting it objectively
and without exaggerating its properties,
-
shall not be misleading.
9
Ban on Direct-to-Consumer Advertising of
Prescription Drugs: Article 88 & new 88a
88.1. Member States shall prohibit the advertising to the general
public of medicinal products which:
- are available on medical prescription only
-
contain psychotropic or narcotic substances,
Within 3 years of the entry into force of Directive 2004/726 (i.e., by
late 2008), the European Commission, after consultation with
stakeholders, shall submit a report on “current practice with
respect to information provision — particularly on the internet —
and its risks and benefits for patients.”
Following analysis of the above data, the Commission shall, if
appropriate, put forward proposals setting out an information
strategy to ensure good-quality, objective, reliable and nonpromotional information on medicinal products and other
treatments and shall address the issue of the information
sources’ liability.
10
Old and new provisions
Article 91-92 continues content requirements for healthcare
professional ads (consistent with authorisation, accurate, up-todate, verifiable, complete).
Art. 93 requires for sales representatives to be trained, to provide
summary of product characteristics, and to transmit information
and adverse reaction reports to the company’s scientific service.
Art. 94.1: Gifts must be inexpensive and relevant to med practice.
New 94.2: Hospitality at sales promotion events shall always be
strictly limited to their main purpose [replaces: Hospitality at
sales promotion shall always be reasonable in level and
secondary to the main purpose] and must not be extended to
persons other than health care professionals.
Art. 94.3. Persons qualified to prescribe or supply medicinal
products shall not solicit or accept any inducement contrary to
paragraph 1 or 2.
Art. 94. 4. Above does not affect “existing” Member State
measures or trade practices re prices, margins and discounts.
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5/15/2006
Events for professional & scientific
purposes: when allowed, Article 95
The provisions of Article 94(1) shall not prevent
hospitality being offered, directly or indirectly, at
events for purely professional and scientific
purposes;
such hospitality shall always be strictly limited to the
main scientific objectives of the event* and it must
not be extended to persons other than health
professionals.
(*Replaces: … “be reasonable in level and remain
subordinate to the main scientific objective of the
meeting…”)
12
Samples, Monitoring
Article 96 continues limits on samples. Little change
except NEW “(d) sample shall be no larger than the
smallest presentation on the market”
Article 97: Member States shall ensure that there are
adequate and effective methods to monitor advertising.
Article 98 continues the requirement for the marketing
authorization holder to establish a scientific service in
charge of information about the medicinal products
which the company places on the market.
NEW Article 98.3: The Member State shall not prohibit
the co-promotion of a medicinal product by the holder of
a marketing authorization and one or more companies
nominated by him.
13
Codes complement Member State Laws
Article 97.5 provides for voluntary control of
advertising of medicinal products by self-regulatory
bodies and recourse to such bodies, if proceedings
before such bodies are possible in addition to the
judicial or administrative proceedings.
The new EFPIA code and the newly revised codes at
national level are part of this complementary control
system.
14
5/15/2006
EFPIA Code Revision
ƒ The EFPIA (European Federation of
Pharmaceutical Industries and Associations) has a
revised code of practice that took effect December
31, 2005.
ƒ EFPIA comprises 29 national pharmaceutical
industry associations and 43 leading
pharmaceutical companies involved in the
research, development and manufacturing of
medicinal products in Europe for human use.
ƒ The national codes are being revised in light of
changes in the Community code on medicinal
products and in the EFPIA code.
15
What EFPIA Code Does Not Cover
“The EFPIA Code is not intended to restrain or
regulate the provision of non-promotional medical,
scientific and factual information; nor is it intended
to restrain or regulate activities directed towards the
general public which relate solely to nonprescription only medicines. EFPIA, however,
acknowledges that some member associations
address these activities in their respective national
codes, and encourages other member associations
to do so, where appropriate.”
16
EFPIA Code is the Minimum
The EFPIA Code sets out the minimum standards
which EFPIA considers must apply. In a manner
compatible with their respective national laws and
regulations, member associations must, at a
minimum, adopt in their national codes provisions
no less rigorous than the provisions contained in
the EFPIA Code. Member associations are
encouraged to tailor their national codes to adapt to
national conditions and to adopt additional
provisions which extend further than the minimum
standards included in the EFPIA Code.
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5/15/2006
National Codes of Practice for the Promotion of
Medicines listed on the EFPIA site
• UK: Code of Practice for the
Pharmaceutical Industry (UK)
ƒ Belgium1919: “Code de Déontologie
concernant les Médicaments à usage
humain” - Code of deontology
ƒ Finland: “National Code of Practice for
the Marketing of Medicinal Products”
France: “Charte de la Visite Médicale” (in
French only) - “Référentiel des Bonnes
Pratiques de la Visite Médicale des
Entreprises du Médicament” (in French
only)
ƒ Germany: Code of Practice of the
German Pharmaceutical Industry
ƒ Greece: Code of Practice on the
Promotion of Prescription only Medicinal
Products
ƒ Ireland: Code of Pharmaceutical Practice
for the Pharmaceutical Industry
ƒ Italy: Code of Professional Conduct
ƒ Norway: Rules Governing Drug
Information
ƒ Portugal: Code of Ethics for the
Pharmaceutical Industry's Promotional
Practices
ƒ Slovenia: Code of Practice for Advising,
Introducing and Informing on
Prescription Medicines
ƒ Spain: Code of Practice for the Promotion
Medicines
ƒ Sweden: Rules Governing Drug
ƒ Information
ƒ Agreement on forms of cooperation
between pharmaceutical companies and
medical professionals in the public
healthcare sector
ƒ Comments on the Agreement
ƒ Switzerland: Code of Conduct of the
Pharmaceutical Industry in Switzerland
ƒ The Netherlands: Code of Conduct for
Pharmaceutical Advertising
ƒ Turkey: Code of Ethical Promotion
Practices for Medicinal Products
18
Duties of EFPIA Member Companies
EFPIA member companies must comply, and must
ensure that their respective subsidiaries comply,
with applicable codes (as defined below) and any
laws and regulations to which they are subject.
Member associations must establish adequate
procedures for ensuring that their respective
member companies comply with applicable codes.
Promotion which takes place within Europe must
comply with applicable laws and regulations. In
addition, promotion which takes place within Europe
must also comply with each of the following
“applicable codes”:
19
What local codes apply and when
(a) (i) in the case of promotion that is undertaken, sponsored or
organized by a company located within Europe, the member
association national code of the country in which such company is
located; or (ii) in the case of promotion that is undertaken,
sponsored or organized by a company located outside of Europe,
the EFPIA Code; and
(b) the member association national code of the country in which the
promotion takes place.
In the event of a conflict between the provisions of the applicable
codes set forth above, the more restrictive of the conflicting
provisions shall apply.
…“company” as used in this EFPIA Code, shall mean any legal entity
that organizes or sponsors promotion which takes place within
Europe, whether such entity be a parent company (e.g., the
headquarters, principal office, or controlling company of a
commercial enterprise), subsidiary company or
… any other form of enterprise or organization.
20
5/15/2006
How the various industry codes relate to
one another
To facilitate compliance with applicable codes, each
member association must establish adequate
procedures for ensuring that each of its member
companies complies with the requirements of such
member association’s national code and any other
member association’s national code which may be
applicable to its conduct, even if the member
company does not belong to the other member
association.
Additionally, all international events (as defined in
the EFPIA Code) must be notified to any relevant
local subsidiary or, alternatively, local advice taken.
21
Article 5, EFPIA Code
Acceptability Of Promotion
ƒ Companies must maintain high ethical
standards at all times.
Promotion must:
(a) never be such as to bring discredit upon, or
reduce confidence in, the pharmaceutical
industry;
(b) be of a nature which recognises the special
nature of medicines and the professional
standing of the recipient(s); and (c) not be
likely to cause offence.
22
Article 7, EFPIA Code
Transparency of Promotion
ƒ Promotion must not be disguised.
ƒ Clinical assessments, post-marketing surveillance and
experience programmes and post-authorization studies
must not be disguised promotion. Such assessments,
programmes and studies must be conducted with a
primarily scientific or educational purpose.
ƒ Where a company pays for or otherwise secures or
arranges the publication of promotional material in journals,
such promotional material must not resemble independent
editorial matter.
ƒ Material relating to medicines and their uses, whether
promotional in nature or not, which is sponsored by a
company must clearly indicate that it has been sponsored
by that company.
23
5/15/2006
Article 9, EFPIA Code
Events and Hospitality
All promotional, scientific or professional meetings,
congresses, conferences, symposia, and other similar events
(each, an “event”) organized or sponsored by a company
must be held in an appropriate venue that is conducive to the
main purpose of the event and may only offer hospitality
when such hospitality is appropriate and otherwise complies
with the provisions of any applicable code(s).
No company may organize or sponsor an event that takes
place outside its home country (an “international event”)
unless:
ƒ most of the invitees are from outside of its home country
and, given the countries of origin of most of the invitees, it
makes greater logistical sense to hold the event in another
country; or
ƒ given the location of the relevant resource or expertise that
is the object or subject matter of the event, it makes
greater logistical sense to hold the event in another
country.
24
Article 9, EFPIA Code
ƒ
ƒ
ƒ
ƒ
ƒ
Hospitality extended in connection with promotional,
professional or scientific events shall be limited to travel,
meals, accommodation and genuine registration fees.
Hospitality may only be extended to persons who qualify as
participants in their own right.
All forms of hospitality offered to healthcare professionals shall
be reasonable in level and strictly limited to the main purpose
of the event. As a general rule, the hospitality provided must
not exceed what healthcare professional recipients would
normally be prepared to pay for themselves.
Hospitality shall not include sponsoring or organizing
entertainment (e.g., sporting or leisure) events. Companies
should avoid using venues that are renowned for their
entertainment facilities.
Companies must comply with guidance concerning the
meaning of the term “reasonable”, as used in this Article 9, as
provided in, or in connection with, any applicable code(s).
25
Article 10 restates and extends the Community
code provisions on gifts
ƒ Except where they carry all information stipulated for
ads, gifts may bear no more than the name and logo of
the company and the name of the medicinal product, or
its international non-proprietary name, where this exists,
or the trademark.
ƒ Gifts for the personal benefit of healthcare professionals
(such as tickets to entertainment events) should not be
offered or provided.
ƒ Companies must comply with guidance concerning the
term “inexpensive” as provided in, or in connection with,
any applicable code(s).
26
5/15/2006
Annex: GUIDELINES FOR INTERNET WEBSITES
AVAILABLE TO HEALTHCARE PROFESSIONALS,
PATIENTS AND THE PUBLIC IN THE EU
The Guidelines are intended as a supplement to the provisions of
the EFPIA Code.
Member associations and companies may find it necessary to
adapt these guidelines to meet their particular requirements or
needs and are encouraged to adopt additional measures which
extend further than the provisions included in these guidelines.
The Guidelines deal with transparency as to website sponsorship,
content, inquiries, etc.
“Companies should ensure that scientific and medical
information prepared by them for inclusion in their websites is
reviewed for accuracy and compliance with the applicable
code(s). “
27
European Healthcare Fraud and Corruption
Office on the horizon?
ƒ In October 2004, the European Healthcare Fraud and
Corruption Conference in London laid the groundwork
for the creation of a European Healthcare Fraud and
Corruption Office (EHFCO).
ƒ This is an initiative of six organizations responsible for
countering healthcare fraud and corruption in their
country or region.
ƒ The participants in the October 2004 conference hoped
the EHFCO would be operational by October 2005, but
this was overly optimistic.
28
United States
The Seven Elements of an Effective Compliance
Plan (U.S. Health and Human Services Insp Gen)
Many companies are using this list as guidance:
a.
Implement written policies and procedures;
b.
Designate a compliance officer and
compliance committee;
c.
Conduct effective training and education;
d.
Develop effective lines of communication;
e.
Conduct internal monitoring and auditing;
f.
Enforce standards through well-publicized
disciplinary guidelines; and
g.
Respond promptly to detected problems and
undertake corrective action.
29
5/15/2006
Enforcement under U.S. laws can be triggered
by marketing practices abroad
ƒSarbanes Oxley (lax controls on drug sales representative’s
travel and expenses might be viewed as a SOX issue)
ƒ Disclosure requirements in securities laws (the
Securities and Exchange Commission takes the position that
companies must disclose material information about certain
enforcement actions by foreign governments)
ƒ Foreign Corrupt Practices Act
ƒ U.S. prosecutors’ interest in what international sales
and marketing activity says about compliance.
Examples: SEC case involving charities in Poland,
Micrus case involving alleged bribes of governmentemployed doctors in France and Turkey
30
Problem areas: off-label use, payments, and
hospitality
•Sponsorship of events can raise numerous legal
issues.
•What if there are discussions of unauthorized
products or unauthorized uses of approved
products?
•Laws vary, but whether off-label discussions are
permitted often depends on whether an event is
viewed as a promotional activity or as a scientific or
educational program.
31
When and for what purposes may a drug company
give a doctor money or other pecuniary benefits?
While it is understood that payments for inducing prescribing
are strictly forbidden,
•Under what circumstances may doctors be hired as speakers,
investigators, or consultants without such arrangements being
viewed as improper inducement?
•What kinds of hospitality may be funded by companies in
connection with promotional events or with scientific or
educational programs?
• It is in this area where change has been particularly rapid, at
least in North America and Europe, yet is one in which
companies are still getting into trouble with authorities and
code bodies.
32
5/15/2006
Officials are looking for evidence of illegal
inducements to prescribe or use products
Increasingly regulations or industry codes forbid
certain forms of entertainment altogether, such as
tickets to sports events, or seek to ensure that
medical content predominates over hospitality.
Company relationships with healthcare
professionals that involve off-label use, payments to
doctors, or subsidy of travel and entertainment are
the ones most likely to attract attention from
regulators, prosecutors, and code officials. under
many countries’ regulatory laws or various criminal
code provisions.
33
Building a shield:Compliance plans that work;
avoiding ones that are unrealistic and
unachievable
•How is a compliance plan best accomplished?
•There may be an inclination to view creation of a compliance plan
as primarily a drafting exercise: write down the policies and to
publish them; identify “best practices” from a range of sources
and put into the corporate compliance plan.
•The problem with this seemingly common sense and
straightforward approach is that it is, in fact, academic and
idealistic.
•It can create standards for the organization, without taking steps
at the same time to change behavior and internal norms.
•In the event of a problem, the gap between what the company
says it does, and what its employees do in fact, can result in an
enforcement nightmare – bad conduct and also bad documents.
34
Building a shield: Avoiding compliance plans
that are unrealistic and unachievable
•A better and more pragmatic approach is beginning with an
assessment of the organization’s current understanding and
approach to regulatory compliance.
•Such an assessment can identify existing practices that
already promote compliance as well as gaps to be filled.
•For multinational corporations, it will be necessary to identify
any country-specific laws that need to be considered.
•A key step is the identification of those business activities that
should be the subject of policies and procedures.
• Again the greater the enforcement risk, the greater the level of
controls that should be considered.
35
5/15/2006
Building a shield: coping with rapidly changing
regulatory landscape and unfamiliar regulators
Set risk-based priorities: company code needs to be strictest on:
• the regulators’ and codes authorities’ areas of concern: offlabel issues, hospitality, congresses, payments to doctors.
• laws that forbid bribery, kickbacks, waste of public
healthcare funds, or tax evasion.
• areas where there is risk of accusation that a company’s
payments influenced the choice of products funded by a
public healthcare system.
U.S.-headquartered companies are developing global
compliance plans due to offshore activities conducted
abroad by affiliate companies.
36
Building a shield: Standards and policies
•The foundation for any compliance plan is the issuance of
standards and policies to guide business conduct.
•Since pharmaceutical manufacturers typically operate in
multiple jurisdictions, there must be an undertaking to identify
all applicable guidance for each jurisdiction (laws and codes).
•That information then needs to be translated into policies,
using language and examples that can be readily understood
by the business people who have to follow them.
•Although there may be certain legal requirements that are
unique to a particular jurisdiction, the policies should attempt
to set forth broad standards of ethical conduct that should be
considered generally acceptable.
37
Building a shield--The compliance plan
•In a compliance plan a company can structure its
business activities to address regulatory risks and to
reduce the possibility of unacceptable behavior by
employees.
• A primarily reactive approach does not suffice.
•Policies and procedures are just pieces of paper (or
computer bytes).
Compliance issues pose business risks that must be
actively managed like any other business challenge.
• What does this mean in practice?
38
5/15/2006
Building a shield:
Assignment of compliance responsibility
•To have an effective compliance plan, employees in sales and
marketing need to know that compliance is part of their jobs.
•There must be personnel charged with seeing that the
compliance plan is being implemented and followed.
•Responsibility should be vested in a high level manager
who has access to the highest levels within the organization.
•It is helpful if the compliance official is a lawyer or has access
to sophisticated legal advice,
• consistent across the business organization to the maximum possible
extent but
• taking into account the requirement to comply with national variations
that are even more stringent than the company’s general norm.
39
Training, access to policies, reminders, building
compliance into performance
• Policies and procedures have no value if employees do not know
about them.
• Thus, part of the compliance mission is to educate and train
employees.
• This training should be fully integrated into standard sales
training and made a part of strategy meetings.
• Compliance materials and testing and evaluation tools should
be readily accessible on-line.
• Every opportunity should be taken to remind employees of
the organization’s ethical precepts and provide information they
need to act according to those precepts.
• Compliance should be part of employee evaluation.
40
Building a shield: Monitoring and auditing
•No matter how good the training materials or the associated
educational effort, experience teaches that some employees do
not, or will not, act as expected.
•For this reason, it is not enough to issue policies and train
people.
•Organizations also must take steps to assess the extent to
which business conduct conforms to compliance standards.
•This is best accomplished through a system of monitoring and
auditing.
•Generally monitoring and auditing serves to assure there is
not a gap between the plan and the reality.
•In some cases, however, auditing may identify instances of
serious misconduct, and those situations must be addressed.
41
5/15/2006
Building a shield: Dealing with non-compliance
•An effective plan can help ensure that any improper
conduct is isolated and contrary to established
written policy.
•The better the procedures to implement the
policies, the more likely that violations will involve
instances of falsification or other forms of deceit by
employees seeking to circumvent the policy.
•Typically, such a fact pattern puts an organization
in a much stronger position to address any
questions from outside parties such as government
bodies or trade code enforcement groups.
42
Building a shield: Dealing with non-compliance
•The critical consideration is whether the organization
responds to violations in a way that is consistent with its
overall compliance objectives.
•One aspect of a response is the application of appropriate
discipline commensurate with the violation.
•To have credibility, discipline must include everyone who
participated in a material way, not just lower level employees.
•The organization needs to learn from its problems by taking
steps to understand why the violation happened and identify
changes in the procedures that might avoid recurrences.
•Finally, the organization must determine whether the violation
is of a type and scope to warrant some form of disclosure to
regulators.
43
Conclusion
¾Complex regulatory environment
¾Increased enforcement
¾Global effects of national laws and enforcement
¾Industry efforts in the form of codes and individual
company compliance efforts
¾A compliance plan as a key part of the company’s
response
¾Questions??
44
5/15/2006
For Reference:
National Laws and Codes
on Marketing Practices
45
UK developments on marketing practices:
ƒ
House of Commons Select Health Committee
report on influence of the pharmaceutical
industry (2005)
ƒ
MHRA Blue guide:Advertising and promotion
of medicines in the UK
ƒ
MHRA enforcement actions
ƒ
Joint memorandum of understanding between
the ABPI, PMCPA and the MHRA
ƒ
New Association of British Pharmaceutical
Industry (ABPI) code effective 1 January 2006
ƒ
ABPI actions
46
UK MHRA Blue Guide:
Advertising and promotion of medicines
November 2005: MHRA published an updated “Blue Guide” on
'Advertising and promotion of medicines in the UK'.
The new Blue Guide reflects:
ƒ
new legislation on promoting medicines to the public, and
ƒ
a greater transparency in MHRA’s activities in this area.
The guidance was launched at a seminar on 22 February 2005
There will be another seminar later this year launching the final Blue
Guide and raising awareness of the implementation of changes in the
legislation resulting from the “2001 Review” in October 2004. Look out
for announcements on the MHRA website!
47
5/15/2006
UK MHRA Blue guide:
Advertising and promotion of medicines
Key changes are:
Greater scrutiny: Companies which regularly breach the guidelines
may also be subject to review of their whole advertising portfolio to
ensure that it meets appropriate standards.
Tougher measures against poor practice: companies exhibiting
poor practice will be “named and shamed” in reviews arising from
scrutiny and complaint investigations published on the MHRA
website
Further guidance on the distinction between disease awareness
campaigns and advertising, internet advertising and gifts and
meetings given by companies.
The guidance will be offered for public consultation.
48
UK Advertising: Naming of competitor
Advertising: Naming of competitor company in
outcome reports of complaints investigated:
Effective 1 January 2005, the MHRA has begun naming
complainants in outcome reports where the complaint
originated from a competitor company.
However, for those complaints received from any other
sources, including healthcare professionals and private
individuals, the identity of the complainant will continue
to remain confidential.
This proposed change coincided with the coming into
force of the Freedom of Information Act.
49
UK MHRA: recent enforcement actions
28 Feb 2006 complaint involving misleading advertising
(unlicensed indication and exaggerated promotional claims
involving Prohance and other products, in healthcare
professional advertisements) was upheld by the MHRA
16 Feb 2006 Advertising complaint involving diabetes
leaflet for healthcare professionals Æ Eli Lilly’s issuance
of a corrective statement regarding a leaflet entitled
"Diabetes: Facts to consider when caring for mental illness"
50
5/15/2006
UK MHRA: recent enforcement actions
1 Feb 2006 Advertising complaint: Kentera
(oxybutnin), healthcare professional advertisement –
November 2005
UCB Pharma has withdrawn an advertisement and
promotional material containing misleading claims that
the side effect of dry mouth was comparable with
placebo levels in clinical trials.
1 Feb 2006 Advertising complaint: Venofer (iron
Sucrose) Promotional Brochure – November 2005
Syner-Med has issued a corrective statement relating to
two promotional pieces that contained misleading claims
about anaphylaxis-type reactions
51
UK MHRA: recent enforcement actions
20 Jan 2006 Advertising complaint DTaP Vaccines
(diptheria, tetanus, pertussis) website promotion –
November 2005
Direct Remedies has removed misleading information
concerning DTaP vaccines from its website.
20 Jan 2006 Advertising complaint Protium
(pantroprazole) promotion – November 2005
Ashbourne Pharmaceuticals has recalled a circulated email which appeared to promote Protium on the basis of
reimbursement arrangements and discount offers.
52
MHRA: recent enforcement actions
20 Jan 2006 Advertising complaint Tamiflu
(oseltamavir), GP Mailer – November 2005
Roche agreed to amend a General Practitioner mailer to
clarify the use of the influenza treatment Tamiflu.
20 Jan 2006 Advertising complaint Single dose
Measles, Mumps and Rubella Vaccines, consumer
advertisement – January 2005
MHRA upheld a complaint concerning an advertisement for
measles, mumps and rubella by single injection provided
by Private MMR Vaccination Clinic.
53
5/15/2006
UK Medicines and Healthcare products Regulatory
Agency (MHRA) MOU with ABPI and PMCPA
This joint memorandum of understanding among the
MHRA, ABPI, and the PMCPA (UK Prescription
Medicines Code of Practice Authority) sets forth the
arrangements for the regulation of the promotion of
medicines for prescribing in the UK.
It is available on the MHRA website, www.mhra.gov.uk
54
UK/ New ABPI code: key changes
ƒ
Patient safety is being further promoted by a requirement for
all printed, promotional material to include prominent
information about reporting adverse drug reactions.
ƒ
Further definition and restrictions are being applied on what
may be provided to health professionals in the way of
promotional aids, hospitality, subsistence, travel, and
accommodation.
ƒ
Relationships with patient groups and the provision of
information to the public are covered in greater depth.
ƒ
A reduction in the permitted number of pages of medicines
advertising and an outright ban on all promotional
competitions are introduced.
55
UK/ New ABPI code: key points of the review
ƒ
The complaint determination process has been
expedited. Decisions can be made and
sanctions imposed more quickly.
ƒ
Materials or activities ruled in serious breach of
the code may, under certain circumstances, be
suspended, even if an appeal is intended,
reducing the time such material remains in use.
ƒ
Results of serious cases will be advertised in the
medical and pharmaceutical press.
56
5/15/2006
UK/ABPI: Relationships with health
professionals
ƒ
ƒ
ƒ
ƒ
ƒ
It is now specifically stated that items must
not be offered for the personal benefit of
health professionals or administrative staff.
It remains the case that items must be
inexpensive - the limit is £6, excluding VAT and relevant to the recipients' profession
promotional aids are more likely to be
acceptable under the new code if they benefit
patient care
more guidance is provided on the types of
items that are both acceptable and
unacceptable
promotional competitions and quizzes are
banned
57
UK/ABPI: Relationships with the public
and patient groups
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ƒ
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More guidance on how companies may respond to
patients' needs for reference information on
medicines.
Promotion of prescription-only medicines to the
public remains strictly prohibited.
New: While companies are permitted to work with
patient advocacy groups, their involvement must be
made clear, and rules on arrangements for meetings
are the same as those for health professionals.
Companies must make public a list of all patient
organizations to which they provide financial
support, and a written agreement must be in place
with every organization spelling out exactly the
terms of the relationship and funding of every
58
significant activity or ongoing co-operation.
UK/ABPI: Complaints and sanctions
ƒ
ƒ
ƒ
a company accepting a ruling of the Code of
Practice Panel has just five working days instead of the current ten - to stop use of the
material.
if the material or activity found in breach is
likely to prejudice public health or safety, or is
a serious breach of the code, the company will
be required to suspend use of it even if an
appeal is planned.
new code gives additional sanctions to the
Appeal Board and also allows for details of
serious cases to be advertised in
pharmaceutical or medical press.
59
5/15/2006
UK/ABPI action
One leading company has been suspended from
membership of the Association of the British
Pharmaceutical Industry (ABPI) for a minimum of
six months in connection with serious breaches
of the ABPI Code of Practice
The complaints (made in 2004 under the 2003
version of the code) concerned inappropriate
hospitality for health professionals.
60
Austria: no more “natural rebate”?
Austrian doctors had been charging the German
medical insurance system for free medicines
received from pharmaceutical companies.
Starting 1 January 2006, an alternative system was
put in place in which doctors would be paid up to 50
% of a medicine’s value as an agreed bonus.
However, no regulatory framework was set up for
the new payments system. Is it open to abuse?
61
Denmark: industry charter
The new charter of the Danish pharmaceutical industry
association (LIF) and the associations of pharmacies,
wholesalers, generics and parallel importers was signed
on 28 December 2004.
The Charter aims to achieve :
• full transparency and
• ethical behavior in all relations among manufacturers,
wholesalers and pharmacies
• increased self-regulation.
The veterinary medicine association (VIF) recently
joined.
62
5/15/2006
France: article L. 4113-6 of the FPHC
Implementation of articles 94, 95 and 99 of community
code:
ƒ Prohibits donations and gifts to persons who prescribe
or deliver drugs
ƒ Limits hospitality at sales promotion or scientific events
ƒ Applies only to companies with one or more products
reimbursed by the social security system
ƒ Imposes pre-approval procedure for hospitality &
scientific studies
ƒ Extensive interpretation by the national physicians
association and by the DGCCRF
ƒ Controls implemented by the DGCCRF
63
What is the DGCCRF?
DGCCRF is a unit of the Ministry of Finance in
charge of enforcing competition and consumer
policy.
the initials DGCCRF stand for :
"Direction Générale de la Concurrence, de la
Consommation et de la Répression des Fraudes“
Fraudes“
Which would mean: Directorate General for
Competition, Consumer policy and fraud repression.
64
France: penalties under Article l. 4113-6
Criminal sanctions may be imposed on healthcare
professionals and legal representatives of
healthcare companies:
Fine of Euro75,000 and a maximum of 2 years
imprisonment (article L. 4163-2 of the FPHC)
Since March 2002, possibility of imposing criminal
sanctions on healthcare companies themselves:
fine of Euro375,000 and loss of the right to
participate in public tender procedures (article L.
4163-2 of the FPHC)
65
5/15/2006
Germany: Unfair Competition Law
Section 4 No. 11 Act against Unfair Competition:
it is regarded as unfair competition to violate statutory
provisions regulating the behavior in the market in the
interest of market participants. Sections 17 to 35 of the
Doctors Professional Code are regarded as provisions
which regulate the behavior of doctors in the market.
If a pharmaceutical company causes a doctor to
violate Section 33 para. 1 of the Doctors´
Professional Code, it violates the Unfair Competition
Law.
66
Germany: Criminal Law
Anticorruption provisions adopted by the German
Parliament in 1997.
Section 331 Criminal Code: Acceptance of a benefit by
a public official
Applicable to employees in state owned or municipal
hospitals or employees in private companies the
shareholders of which are public entities.
Section 331 para. 1 applies even if at the time the public
official receives the benefit it is not yet determined which
official act he will exercise in the future. The aim of
obtaining the officials´ general benevolence towards the
“donor” suffices for the criminal offence.
Section 333 Criminal Code, Grant of a Benefit:
The responsible person who causes a doctor to violate
Section 331 Criminal Code commits an offence (Sec 333). 67
Germany: Doctors´ Professional Codes
Renewed by the State Medical Associations of the
German Länder in 2003/2004: “Section 33 Doctors
and Industry” as applicable in most German Länder
- Remuneration for services for manufacturers of
pharmaceuticals must be appropriate to the service
(Section 33 para. 1).
- Doctors may not receive gifts and benefits unless they
are low of value (Section 33 para. 2).
- Acceptance of appropriate monetary benefits for the
attendance of vocational training events does not violate
professional laws. A benefit is inappropriate if it exceeds
the costs of the doctor’s participation or training does not
take center stage (Section 33 para. 3).
68
5/15/2006
Germany: Conduct Recommendations for the Cooperation
between the Pharmaceutical Industry and Physicians
Published in 2003 by the Association of the German
Drug Manufacturers (BAH), the German Association of
the Pharmaceutical Industry (BPI) and the Association
of Research-Based Pharmaceutical Companies (VFA)
- Section 4.1: Physicians may render services for
companies only based on written agreements that clearly
state both the nature of the service and the remuneration.
- Section 4.3: Remuneration must be exclusively in cash
and must be proportionate to the service rendered.
69
Germany: German Pharmaceutical Industry
Association's Code of Conduct
Published by the German Association of the
Pharmaceutical Industry (BPI) in 2000.
Section 17
- Remuneration for services rendered by doctors to
pharmaceutical companies must only be in cash,
based on a written agreement (para. 1).
- Remuneration must not exceed an appropriate level
and must be commensurate with the service rendered
(para. 2).
70
Germany : 2003 recommendations
May 2003: “Conduct Recommendations for the
Cooperation between the Pharmaceutical Industry
and Physicians”
Published by the German Association of
Pharmaceutical Industry, the Federal association of
the medical manufacturers and Federation of
medical research manufacturers
71
5/15/2006
Italy :
2004: 4,000 doctors and 273 drug company
employees faced charges of alleged unlawful
business practices
Allegedly involved offers of “cash, gifts and prizes to
doctors and other healthcare professionals to encourage
them to prescribe..."
72
Italy : alleged improper payments
2006: company might be fined for alleged improper
payments to doctors in connection with a screening
programme for rare diseases, fees for publishing
articles, and conducting clinical trials etc.
There also were accusations of conducting
screening for rare diseases without the patients’
knowledge.
73
Lithuanian authority fines health supplement
company due to misleading advertisement
ƒThe Lithuanian competition authority has fined Ostron, UAB
Getz Medical Baltic for misleading advertisements for a
mineral-rich supplement
ƒThe company asserted that the product was three times
stronger and more efficacious, and yet one-third as expensive
than any other similar product.
ƒClaims that: "worldwide, Ostron has been recognised as bone
and teeth strengthening preparation of especially good
composition-Number One," were also judged to be inaccurate
by the competition authority.
ƒThe Lithuanian authority fined the advertising company a total
of Euro 4,300 and requested it to cease its illegal advertising
campaign.
74
5/15/2006
The Netherlands:
First action on misleading advertisement
The Dutch Medicines Advertising standards Agency
(CGR) took action against Dutch unit of a leading
German company for the allegedly misleading
advertising of a product after accepting complaints
by the Dutch Medicines Evaluation Board (MEB).
Case is notable because this is the first time that the
MEB has lodged an advertising complaint.
75
Spain: Committee to examine marketing practices
As part of a national strategic plan, the Pharmacy
Committee of the Spanish National Health System
will look at:
ƒ The promotion and advertising of pharmaceuticals
ƒ The accreditation of training and medical
conferences
ƒ New type of medical prescription form
76
Sweden: Code of conduct for doctors and
industry
Starting 1 January 2005, an agreement between the
Swedish Industry Association and the Swedish
Medical Association is effective.
Agreement is entitled “Industry’s provision of
information and education to healthcare personnel”
ƒ Provides that the industry may pay only up to 50% of the cost of
doctors’ travel and accommodation at conferences;
ƒ Allows industry to cover conference fees;
ƒ Invitations must be sent to the doctor’s employer who will decide
whether the doctor can attend an event
77
5/15/2006
Switzerland: Swiss laws and codes on
advertising of medicinal products
¾Federal law on Medicinal Products and Medical
Devices of 15 Dec. 2000
¾Ordinance on advertising for Medicinal Products of
17 Oct. 2001
¾Code of Conduct of the Swiss Pharmaceutical
Industry of 4 Dec. 2003 (issued by the Swiss Society
of Chemical Industries; based on IFPMA and EFPIA
Code)
78
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