MEDICINES PRODUCTS (INJUNCTION TO ADVERTISING) REGULATIONS

SUBSIDIARY LEGISLATION 458.51

MEDICINES PRODUCTS (INJUNCTION TO

ADVERTISING) REGULATIONS

29th February, 2008

LEGAL NOTICE 60 of 2008.

The title of these regulations is the Medicines Products

(Injunction to Advertising) Regulations.

(1)

In these regulations, unless the context otherwise

requires

"the Act" means the Medicines Act;

"the Authority" means the Medicines Authority established

under article 4 of the Act;

"the Commission" means the Commission of the European

Community;

"Court of Appeal" means the Court of Appeal sitting in its

inferior jurisdiction as constituted in terms of article 41(9) of the

Code of Organization and Civil Procedure;

"the Directive" means the provisions of Directive 98/27/EC of

the European Parliament and of the Council of 19th May, 1998 on

injunctions for the protection of consumers’ interests;

"EEA State" means any State which is a contracting party to the

agreement on the European Economic Area signed at Oporto on the

2nd May, 1992 as amended by the Protocol signed at Brussels on

17th March, 1993 and as amended from time to time;

"European Community" means the organisation established by

the Treaty of Rome in 1957 and amended institutionally and

otherwise in 1986 by the Single European Act, in 1993 by the

Treaty on European Union, in 1997 by the Treaty of Amsterdam

and in 2001 by the Treaty of Nice and as amended by accession

agreements and as may be further amended from time to time;

"list of qualified entities" means the list compiled and updated by

the Commission and published in the Official Journal of the

European Communities listing the qualified entities in Member

St a te s an d E E A St a t es i n ac c o r d an c e w i t h A r t i cl e 4 o f t h e

Directive;

"medicinal products" means medicinals for human use;

"Member State" means a member of the European Community;

"the Minister" means the Minister responsible for health;

"qualified entity" means any body or organization which, being

properly constituted according to the law of a Member State, has a

legitimate interest in ensuring that the provisions referred to in

regulation 3 are complied with and, without prejudice to the

generality of the foregoing, includes

(a) a registered consumer association within the meaning

of Part IV of the Consumer Affairs Act;

(b) one or more independent public bodies, having a

legitimate interest in ensuring the protection of the

collective interests of consumers of medicinal

products advertising in other Member States or EEA

States in which such bodies exist;

(c) voluntary organisations in other Member States or

EEA States whose purpose is to protect the interests

referred to in paragraph (a) of this definition in

accordance with the criteria laid down by their

national law;

(d) organisations recognised by the Authority as

collectively

representing

medicinal

products

manufacturers, suppliers and distributors; or

(e) any qualified entity from a Member State or EEA State

included in the list of qualified entities;

"the 2005 Regulations" means the Medicinal Products

(Advertising) Regulations.

(2) Words and expressions used in these regulations which are

also used in the Act or in the 2005 Regulations shall have the same

meanings as in the Act or in the said regulations.

The object of these regulations is to implement the

provisions of the Directive, as applicable to the advertising of

medicinal products contained in Directive 92/28/EEC as transposed

by the 2005 Regulations, and shall be interpreted and applied

accordingly.

These regulations apply to any advertising of medicinal

products in or from Malta as regulated by Directive 92/28/EEC.

(1) Where a qualified entity wishes to seek a compliance

order, it shall submit its written application to the Authority. In its

application, it shall satisfy the Authority that it has tried to achieve

the cessation of the infringement in consultation with either the

defendant or both the defendant and another qualified entity of the

Member State or EEA State in which the injunction is sought. The

Authority shall only entertain a written application if the qualified

entity shows to its satisfaction that the cessation of the

infringement was not achieved within two weeks after the request

for consultation was received.

(2) Where the qualified entity is from another Member State or

EEA State, the Authority shall treat the list of qualified entities

published by the Commission as conclusive proof of the legal

capacity of the legal entity to present such written application in

Malta.

(3) The Authority shall, at the request of a qualified entity from

Malta, communicate to the Commission the name and objects of

such entities and that such qualified entity should be added to the

list of qualified entities so as to facilitate the redress of inter-

community infringements.

(4) Before proceeding for the issue of a compliance order under

regulation 6, the Authority shall, if it considers it to be possible and

reasonable to do so, seek first to achieve voluntary compliance by a

person licensed under the Act and other persons involved, in

accordance with these regulations, the Act or any other law dealing

with consumer rights and protection.

(5) For the purposes of these regulations, an infringement

occurs when any act is committed contrary to Directive 92/28/EEC

as transposed by the 2005 Regulations.

(1) Where the Authority feels it reasonably appropriate or

necessary for the protection of consumers, it may, on a written

application to it by a qualified entity, issue a compliance order

against any person licensed under the Act for one or more of the

following purposes

(a) ordering any such person to cease any advertisement

of a medicinal product which the Authority considers

to be in breach of the provisions of the 2005

Regulations;

(b) requiring such person to take any measures specified

in such order, within the time specified in the

compliance order to ensure that such order is complied

with;

(c) requiring such person to cease or desist from

committing a breach of these regulations or of the

provisions of the Act regulating advertisements or of

the 2005 Regulations.

(2) The Authority shall, when issuing a compliance order under

these regulations -

(a) serve a copy of the compliance order on each person

against whom the order is made;

(b) include with the compliance order, information about

the right to institute an action before the Court of

Appeal, in accordance with regulation 9; and

(c) briefly state the reasons for issuing the compliance

order, which reasons shall be notified to each person

against whom the compliance order is issued and, if

any, to the qualifying body on whose application the

compliance order is issued.

(3) No precautionary warrant or other order under any other

l a w s h a l l b e i s s u e d b y a n y c o u r t o r t r i b u n a l r e s t r a i n i ng o r

restricting the Authority from issuing a compliance order under

such order.

(1) It shall be at the discretion of the Authority whether or

not to issue a compliance order after a written request by a

qualified entity has been made to it in terms of regulation 6(1).

(2) If the Authority decides not to issue a compliance order

after an application has been made to it by a qualified entity, it

shall, within seven days from the date of its decision, notify in

writing the qualified entity and the persons against whom the

compliance order is requested with its decision stating the reasons

therefore.

(3) A qualified entity may within fifteen days from the date of

notification upon it of the decision of the Authority not to issue a

compliance order, institute an action before the Court of Appeal for

the issue of an order requiring the Authority to issue a compliance

order under regulation 6. The persons against whom the

compliance order is requested to be made shall be parties to the

suit, and it shall be the duty of the qualified entity to notify such

persons accordingly.

(4) In the exercise of its functions and powers under these

regulations, the Court of Appeal shall in all cases act as

expeditiously as possible.

A compliance order issued by the Authority shall come

into force with immediate effect.

(1) A person against whom a compliance order has been

made, may, within fifteen days from receipt of notification of the

compliance order, appeal in writing to the Court of Appeal for the

revocation or amendment of the compliance order, giving detailed

grounds for the request. Such appeal may be made only on the

following grounds

(a) the Authority has, in its decision wrongly applied any

of the provisions of these regulations; or

(b) the decision of the Authority constitutes an abuse of

discretion or is manifestly unfair.

(2) The Court of Appeal may confirm, change or cancel the

compliance order on any terms or conditions it considers

appropriate.

(3) Where an appeal is instituted under subregulation (1), the

compliance order shall remain in force unless the Court of Appeal

specifically orders that the compliance order shall be stayed

pending the outcome of the appeal, subject to such conditions and

amendments as it may determine. In any such instance, the

Authority may request the Court of Appeal to make an interim

compliance order, ordering that the compliance order shall, subject

to such modifications as the Authority may suggest, continue in

force pending the final determination of the case instituted in

accordance with subregulation (1). An interim compliance order

shall expire upon the final determination of the case.

(4) Subject to these regulations, the provisions of the Code of

Organization and Civil Procedure shall, mutatis mutandis, govern

appeals to the Court of Appeal.

The Authority, when issuing a compliance order under

regulation 6, shall not be required to prove

(a) actual loss or damage; or

(b) actual recklessness, negligence or fault on the part of

the person against whom the order is made.

(1) The Authority may, for the better information of the

public

(a) publish a copy of the compliance order made under

regulation 6 against any such person, in full or in part;

or

(b) order any person licensed under the provisions of the

Act to publish a corrective statement in relation to any

contravention of these regulations; or

(c) take both measures mentioned in paragraph (a) and

(b).

(2) Publication in terms of subregulation (1) shall be made at

the expense of the against whom the order was issued, in at least

two daily newspapers within seven days from receipt of the notice

and shall be at the expense of the person served with such notice.

Where such publication is not effected as aforesaid, the Authority

may proceed to effect publication itself, in which case it shall have

the right to recover from the person on whom the notice is served,

any expenses incurred, as a civil debt, constituting an executive

title for the purposes of Title VII of Part I of Book Second of the

Code of Organization and Civil Procedure as if payment of the

amount of the civil debt has been ordered by a judgment of a court

of civil jurisdiction.

The Authority may in writing authorize any of its

employees, a public or other officer or any other person to perform

any of its functions in relation to the enforcement of these

regulations or exercise any power granted to it under these

provisions. Any such authorized person shall, when required,

produce the written authorisation signed by the Authority.

(1) The Authority may, for the purpose of discharging its

functions under these regulations, require any person to provide

any information in any manner, including by

(a) answering any questions, orally or in writing; or

(b) producing any item or data as aforesaid as the

Authority may consider to be necessary; or

(c) producing any books, documents or other records as

the Authority may consider to be necessary.

(2) Any such person shall promptly comply with any such

request.

(1) A person licensed under the provisions of the Act,

shall be liable to an administrative penalty in terms of regulation 15

if such person

(a) fails to observe any other provision in these

regulations;

(b) fails to comply with a compliance order issued under

these regulations; or

(c) refuses or fails to furnish information as required

under these regulations or else provides false or

misleading information.

(2) A person licensed under the provisions of the Act, shall be

liable to an administrative penalty if such person

(a) wilfully obstructs, assaults, threatens, resists or

interferes with the Authority or any person delegated

by it in terms of regulation 12 or any public officer in

the exercise of his duties under these regulations or

attempts so to do; or

(b) uses threatening, abusive or insulting language to the

Authority or any person delegated by it in terms of

regulation 12 or any public officer in the course of

duties.

(1) In the event of liability arising in terms of article 14

the Chief Executive of the Authority may by notice in writing

request the Authority to impose on the person licensed under the

provisions of the Act an administrative penalty in terms of article

100 of the Act and the procedure laid down in that article shall

mutatis mutandis apply.

(1) Nothing in these regulations shall prejudice or limit

the exercise of the powers of the Authority to take administrative

measures or impose penalties under the Act, against a person

licensed under the provisions of the Act who has contravened any

provisions of these regulations or has failed to satisfy or comply

with any obligation or condition to which he may be subject under

the Act or the 2005 Regulations.

(2) Nothing in these regulations shall be deemed to restrict or

detract from the powers of the Authority under any other law, or

from the powers of the Police under the Criminal Code or any other

law.

(1) Where an order or notice is required or authorised to

be served under these regulations it shall be served in any of the

following manners

(a) by delivering it, or by sending it by registered mail to

the person on whom it is to be served at such person’s

place of residence, office or place of work; or

(b) in the case of a body corporate or other body of

persons, by delivering it to an officer or servant

thereof at the registered office or any other place of

business, or sending it in a registered letter addressed

to any such office.

(2) In any case where it is not reasonably possible to effect

service in any manner stated in subregulation (1), service may be

affected by publishing a summary of such notice in the Gazette.