379 tal-2016

L.N. 379 of 2016

ENVIRONMENT PROTECTION ACT

(CAP. 549)

Access to Genetic Resources and the Fair and Equitable Sharing

of Benefits arising from their Utilisation Regulations, 2016

BY VIRTUE of the powers conferred by article 54 of the

Environment Protection Act, the Minister for Sustainable

Development, the Environment and Climate Change, after

consultation with the Environment and Resources Authority, has

made the following regulations:-

The title of these regulations is the Access to Genetic

Resources and the Fair and Equitable Sharing of Benefits arising from

their Utilisation Regulations, 2016.

(1)

The aim of these regulations is to ensure the fair

and equitable sharing of the benefits arising from the utilisation of

genetic resources for which Malta has sovereign rights, as well as the

fair and equitable sharing of benefits arising from local traditional

knowledge associated with genetic resources.

(2) These regulations shall not apply to

(a)

human genetic resources;

(b)

genetic resources used as bulk commodities;

(c)

genetic resources acquired prior to the entry into

force of the United Nations Convention on Biological Diversity;

(d)

the genetic resources for which access and benefit-

sharing are governed by specialised international instruments

that are consistent with, and do not run counter to, the objectives

of the Convention and the Nagoya Protocol on Access to

Genetic Resources and the Fair and Equitable Sharing of

Benefits Arising from their Utilisation in the Union;

(e)

genetic resources that Malta determines do not

require prior informed consent;

(f)

marine resources found in areas beyond national

jurisdiction (ABNJ); and

(g)

derivatives accessed independently of genetic

resources.

(3) The provisions of these regulations shall not prejudice

specialised international access and benefit-sharing instruments

which are consistent with the Nagoya Protocol, such as the Pandemic

Influenza Preparedness Framework for the sharing of influenza

viruses and access to vaccines and other benefits (the ‘PIP’

Framework) and the International Treaty on Plant Genetic Resources

for Food and Agriculture (ITPGRFA).

(4) These regulations shall place the national legal regime of

the access to genetic resources and the fair and equitable sharing of

benefits resulting from their utilisation and lay down provisions

required for the implementation of

(a)

Regulation (EU) No. 511/2014 on compliance

measures for users from the Nagoya Protocol on Access to

Genetic Resources and the Fair and Equitable Sharing of

Benefits Arising from their Utilisation in the Union and related

implementing Regulations;

(b)

the Nagoya Protocol on Access to Genetic

Resources and the Fair and Equitable Sharing of Benefits

Arising from their Utilisation to the Convention on Biological

Diversity; and

(c)

Article 15 of the Convention on Biological

Diversity;

and shall be read and construed as one with such legal instruments.

For the purpose of these regulations, the definitions laid Definitions.

down in the Convention on Biological Diversity (Incorporation) S.L. 549.27

Regulations, the Nagoya Protocol, and in the Principal Regulations,

as well as the following definitions shall apply

"assistant authorities" means those authorities designated in

regulation 4 whose function is to assist the competent authority to

implement these regulations;

"certificate of compliance" means a permit or its equivalent

issued at the time of access as evidence that the genetic resource it

covers has been accessed in accordance with the decision to grant

prior informed consent, and that mutually agreed terms have been

established for the use and the utilisation specified therein by the

competent authority in accordance with Article 6(3)(e) and Article

13(2) of the Nagoya Protocol, that is made available to the Access

and Benefit-Sharing Clearing House established under Article 14(1)

of the Protocol;

"Committee" means the Access to Benefit Sharing Advisory

Committee;

"Commission Implementing Regulation" means Commission

Implementing Regulation (EU) 2015/1866 laying down detailed rules

for the implementation of Regulation (EU) No 511/2014 of the

European Parliament and of the Council as regards the register of

collections, monitoring user compliance and best practices;

"competent authority" means the Director responsible for Plant

Health Services;

"Council Regulation" means Regulation (EU) No. 511/2014 of

the European Parliament and of the Council of 16 April 2014 on

compliance measures for users from the Nagoya Protocol on Access

to Genetic Resources and the Fair and Equitable Sharing of Benefits

Arising from their Utilisation in the Union;

"due diligence" means the measures taken by a user to ascertain

that the genetic resources and traditional knowledge associated with

genetic resources concerned have been accessed in accordance with

applicable access and benefit sharing legislation or regulatory

requirements such that benefits are fairly and equitably shared upon

mutually agreed terms;

"genetic resources for which Malta has sovereign rights" means

the genetic resources which originate in Malta or which have been

acquired in accordance with the Convention after the entry into force

of the Nagoya Protocol for the Union;

"inspector" means a person carrying out an inspection in terms

of these regulations;

"the Minister" means the Minister responsible for the

environment;

"Nagoya Protocol" means the Nagoya Protocol on Access to

Genetic Resources and the Fair and Equitable Sharing Arising from

their Utilisation to the Convention on Biological Diversity;

"Principal Regulations" means Regulation (EU) No. 511/2014

of the European Parliament and of the Council of 16 April 2014 and

Commission Implementing Regulation (EU) 2015/1866;

"prior informed consent" means a prior permission or

authorisation issued in terms of regulations 5 and 6 to access genetic

resources or traditional knowledge associated with genetic resources;

"the register" means the register of collections of genetic

resources within the Union, as established through the Principal

Regulations;

"traditional knowledge associated with genetic resources"

means traditional knowledge held by an indigenous or local

community that is relevant for the utilisation of genetic resources and

that is as such described in the mutually agreed terms applying to the

utilisation of genetic resources.

(1)

The competent authority shall be the Director Authorities.

responsible for Plant Health Services.

(2) The competent authority shall be responsible for the

implementation of these regulations, the Council Regulation and the

Nagoya Protocol.

(3) The responsibility of the competent authority shall include

the granting of access to genetic resources through prior informed

consent, issuing internationally recognised certificates of compliance,

carry out the functions of the Member State under Article 5 of the

Council Regulation and advise on applicable procedures and

measures relating to these regulations, and the Council Regulation

Provided that the granting of access to genetic resources through

prior informed consent shall be the responsibility for the assistant

authorities for the following

(a)

the Environment and Resources Authority for

wildlife, as laid down under the Environment Protection Act, Cap. 549.

with the exception of birds protected through the provisions of

the Conservation of Wild Birds Regulations;

(b)

the Wild Birds Regulation Unit for birds, as laid

down under the Conservation of Wild Birds Regulations;

(c)

the Department of Fisheries and Aquaculture, as

laid down in the Fisheries Conservation and Management Act. Cap. 425.

Provided, further that the competent authority shall be assisted

by assistant authorities and an Access to Benefit-Sharing Advisory

Committee, as necessary.

(4) The assistant authorities shall assist the competent

authority in ensuring that the implementation of these regulations, the

Council Regulation and the Nagoya Protocol is in line with the other

relevant sectorial legislations.

(5) Assistant authorities shall establish and maintain an

inventory of the prior informed consents granted and which fall under

their remit, in terms of these regulations.

(6) The competent authority shall each year compile a report

on the implementation of these regulations. The assistant authorities

shall submit the necessary information to the competent authority in

order to be able to compile the report

Provided that the competent authority may request any

additional document and information from the assistant authorities as

reasonably and objectively justified

Provided further that the information shall not be

submitted later than the end of January of the following year.

(7) The report compiled by the competent authority shall

include relevant information relating to the utilisation of genetic

resources, the granting of prior informed consents and the monitoring

of user compliance.

(1)

The access to genetic resources for which Malta

has sovereign rights to other countries shall require prior informed

consent from the competent authority or the assistant authorities, in

accordance with regulation 4(3).

(2) Access, where granted, shall be on mutually agreed terms

between the concerned user of genetic resources and Malta. The

drafting and the negotiation process of such mutually agreed terms

shall be undertaken by the competent authority. The competent

authority shall consult the relevant assistant authorities at any time

during the negotiation process.

(3) Such access to genetic resources should guarantee that the

benefits arising from the utilisation of genetic resources, as well as

any subsequent application and commercialisation shall be shared in a

fair and equitable way with Malta.

(4) Upon the establishment of mutually agreed terms, the

competent authority shall issue the user of the genetic resources a

certificate of compliance as evidence of the decision to grant prior

informed consent and the establishment of mutually agreed terms.

(5) In accordance with Article 17 of the Nagoya Protocol, a

certificate of compliance issued in terms of sub-regulation (4) shall

constitute an internationally recognised certificate of compliance.

(1)

The utilisation of traditional knowledge associated Traditional

with genetic resources held by local communities shall require a joint knowledge.

prior informed consent or approval from the competent authority

following consultation with the relevant assistant authority and the

community or communities concerned where applicable.

(2) No person shall utilise traditional knowledge associated

with genetic resources held by the local communities unless mutually

agreed terms have been established. The drafting and the negotiation

process of such mutually agreed terms shall be undertaken by the

competent authority. The competent authority may consult the

assistant authority at any time during the negotiation process.

(3) Mutually agreed terms shall guarantee that the benefits

arising from the utilisation of traditional knowledge are shared in a

fair and equitable way with the community or communities

concerned.

(1)

The user requesting prior informed consent for the Application for

utilisation of genetic resources, hereinafter referred to as "the prior

consent and

applicant", shall submit in writing an application to the competent confidential

information.

authority or the concerned assistant authority at least six months prior

to utilisation.

(2) The application shall be accompanied by the relevant

documents and any other requisite information as specified by the

competent authority or the concerned assistant authority

Provided that the competent authority or the concerned

assistant authority may request any additional document and

information as reasonably and objectively justified.

(3) Unless the applicant indicates that parts of the application

should be treated as confidential by the competent authority, the

competent authority shall forward the information contained in the

application to the relevant assistant authorities as it deems necessary.

(4) In no case may the following information be kept

confidential

(a)

the name and address of the applicant;

(b)

the institution, if any, requiring the authorisation;

(c)

the species involved;

(d)

the aim and purpose of the application;

(e)

the benefits arising from the permit;

(f)

the possible impacts on local biodiversity,

including the species, biotype, natural habitat, or area involved;

(g)

the evaluation of foreseeable effects, in particular

any harmful effects on the environment.

(5) The competent authority or the relevant assistant authority

shall not divulge to third parties any information provided in the

application.

The competent authority shall facilitate the registration of

collections in the register to be established and maintained by the

European Commission under Article 5 of the Council Regulation.

(1)

The relevant assistant authority shall have the right

to review the records and any specimens held in a collection which is

registered in terms of Article 5 of the Council Regulation, or a

collection covered by a request in accordance with regulation 8. The

outcome of every review should be communicated to the competent

authority within thirty days from the date of inspection.

(2) The competent authority and the assistant authorities under

the supervision of the competent authority shall have the right to

carry out checks on the users of genetic resources, in accordance with

the Council Regulation and the Commission Implementing

Regulation.

The competent authority shall request all recipients of

research funding involving the utilisation of genetic resources and

traditional knowledge associated with genetic resources to declare

that they exercise due diligence in accordance with Article 4 of the

Council Regulation.

(1)

There shall be an advisory committee called the

Access to Benefit Sharing Advisory Committee, hereinafter referred

to as "the Committee". This Committee shall be composed of eleven

(11) members. The Committee shall advise the competent authority in

the implementation of the provisions of due diligence as laid down in

the Council Regulation, as well as providing advice to the competent

authorities on scientific, technical and other relevant matters upon

request.

(2) The Committee shall be composed of the following

(a)

a Chairperson to be appointed by the Permanent

Secretary of the Ministry responsible for the environment;

(b)

one representative from the competent authority;

(c)

a representative from each of the assistant

authorities listed in regulation 4;

(d)

a representative from

the

Directorate

of

Environment and Climate Change;

(e)

a representative from the Ministry responsible for

the economy;

(f)

a representative from the Medicines Authority;

(g)

a representative from the Continental Shelf

Department;

(h)

a representative from the Veterinary Services

Directorate; and

(i)

a representative from the Ministry responsible for

research and development

Provided that the Minister responsible for the environment

may, in consultation with the competent authority, appoint experts in

the field of genetic resources or property rights, as may be required.

(3) The competent authority shall appoint a person to act as

secretary for the Committee.

(4) Without prejudice to any of these regulations, the

Committee may regulate its own procedures and meetings.

The competent authority shall carry out the functions of Complementary

functions.

the Member State under Article 13 of the Council Regulation.

The competent authority may impose a requirement upon a Power to

person to comply with a remedial notice, as set out in these impose

administrative

regulations and may also impose an administrative penalty.

sanctions.

Subject to sub-regulations (2) and (3), Due diligence

administrative fines may be imposed in relation to a failure to comply obligations

the Council

with any of the following provisions

Regulation

which are

subject to

(a)

Article 4(1) of the Council Regulation (obligation administrative

fines.

to exercise due diligence);

(b)

Article 4(3) of the Council Regulation (obligation

to seek, keep and transfer information and documentation to

subsequent users);

(c)

Article 7(1) and (2) of the Council Regulation

(obligation to make a declaration of due diligence).

(2) There is no failure to comply with Article 4(3) of the

Council Regulation if the competent authority is satisfied that -

(a)

the user is considered to have exercised due

diligence under Article 4(4) of the Council Regulation (use of

the Plant Treaty’s Standard Material Transfer Agreement for

material not listed in Annex 1 to that Treaty);

(b)

the user is considered to have exercised due

diligence under Article 4(7) of the Council Regulation (users

obtaining material from a registered collection); or

(c)

the user is in accordance with Article 4(8) of the

Council Regulation (use of pathogen for the purpose of public

health emergency preparedness).

(1)

Bla ħsara għas-subregolamenti (2) u (3), il-penali Obbligi ta’

amministrattivi jistgħu jiġu imposti fir-rigward ta’ nuqqas ta’ diliġenza

tar-Regolament

konformità ma’ kwalunkwe waħda minn dawn id-dispożizzjonijiet li tal-Kunsill

huma suġġetti

ġejjin

għal penali

amministrattivi.

(a)

l-Artikolu 4(1) tar-Regolament tal-Kunsill (l-

obbligu li tiġi eżerċitata diliġenza xierqa);

(b)

l-Artikolu 4(3) tar-Regolament tal-Kunsill (l-

obbligu li wieħed ifittex, iżomm u jittrasferixxi informazzjoni u

d-dokumentazzjoni għall-utenti sussegwenti);

(ċ)

l-Artikolu 7(1) u (2) tar-Regolament tal-Kunsill (l-

obbligu li ssir dikjarazzjoni ta’ diliġenza dovuta).

(2) M’hemm l-ebda nuqqas ta’ konformità mal-Artikolu 4(3)

tar-Regolament tal-Kunsill jekk l-awtorità kompetenti tkun sodisfatta

(a)

l-utent huwa kkunsidrat li jkun eżerċita d-diliġenza

dovuta skont l-Artikolu 4(4) tar-Regolament tal-Kunsill (l-użu

tal-Ftehim tat-Trattat tal-Pjanti dwar Trasferiment Standard ta’

Materjal mhux elenkati fl-Anness 1 ta’ dak it-Trattat);

(b)

l-utent huwa kkunsidrat li jkun eżerċita d-diliġenza

dovuta skont l-Artikolu 4(7) tar-Regolament tal-Kunsill (l-utenti

jiksbu materjal minn ġabra reġistrata); jew

(ċ)

l-utent huwa bi qbil mal-Artikolu 4(8) tar-

Regolament tal-Kunsill (l-użu tal-patoġenu għall-iskop ta’

preparazzjoni ta’ emerġenza fis-saħħa pubblika).

The competent authority, or any such officer or any other

person as may be authorised by the competent authority for this

purpose, shall have the right to inspect any premises or other place for

the purposes of

(a)

the making of inspections;

(b)

ascertaining that nothing contrary to the provisions

of these regulations or of the Council Regulation or to any term,

condition, limitation or specification attached to any

authorisation issued under these regulations or under the

Council Regulation is taking or has taken place, and taking

action accordingly;

(c)

ascertaining or reproducing such

data

or

information as the competent authority may require;

(d)

doing anything that is ancillary or consequential

thereto.

(1)

The person carrying out the inspection, after

serving a notice on the user, and if so required, with the assistance of

the Police Force, may enter premises or other places, except premises

used wholly or mainly as a private dwelling house in order to perform

inspections.

(2) The requirement to serve a notice does not apply -

(a)

where reasonable

efforts

to

agree

on

an

appointment have failed;

(b)

where an inspector reasonably believes that serving

a notice would defeat the object of the entry;

(c)

where an inspector has a reasonable suspicion that

an offence has been committed under regulation 23;

(d)

in an emergency situation; or

(e)

the premises are unoccupied or the occupier is

temporarily absent.

(3) An inspector shall, if requested, produce a duly

authenticated authorisation document.

(4) An inspector entering premises under this regulation may -

(a)

be accompanied by such other persons as the

inspector considers necessary;

(b)

bring onto the premises such equipment as the

inspector considers necessary.

(5) Where an inspector enters premises which are unoccupied

or from which the occupier is temporarily absent, the inspector must

leave them as effectively secured against unauthorised entry as they

were before the inspector’s entry.

(6) An inspector may require a vehicle, vessel, aircraft or

hovercraft, that the inspector has reasonable grounds to believe is

transporting evidence, to stop to allow the inspector to exercise the

powers conferred by these regulations.

An inspector who has entered premises in exercise Powers of

inspection.

of a power under regulation 16 may

(a)

inspect the premises and any products, goods or

biological material found on the premises;

(b)

search the premises;

(c)

have access to inspect and copy documents, records

or other information, in whatever form they are held, and

remove them to enable them to be copied;

(d)

require the production of, and inspect and check

the data on, and operation of, any computer and any associated

apparatus used in connection with such documents, records or

other information, and require computer records to be produced

in a form in which they may be easily accessed and taken away

by the inspector;

(e)

take samples of products, goods or biological

material;

(f)

carry out any examination, investigation or test;

and

(g)

take photographs, measurements or recordings.

(2) An inspector may require any person to provide as may be

necessary for the purpose of enforcing these regulations and the

Council Regulation any -

(a)

assistance;

(b)

documents, records or other information.

(1)

Spettur li jkun daħal f’bini fl-eżerċizzju ta’ setgħa Setgħat ta’

spezzjoni.

taħt ir-regolament 16 jista’

(a)

jispezzjona l-post u kull prodott, merkanzija jew

materjal bijoloġiku li jinstab fil-post;

(b)

ifittex fil-post;

(ċ)

ikollhu aċċess biex jispezzjona u jikkopja u

dokumenti, rekords u informazzjoni oħra, fi kwalunkwe forma li

huma miżmuma, u jneħħihom sabiex ikunu jistgħu jiġu

kkupjati;

(d)

jeħtieġ il-produzzjoni ta’, u jispezzjona u

jivverifika d-data dwar l-operazzjoni ta’, kwalunkwe kompjuter

u kull apparat assoċjat użat b’konnessjoni ma’ tali dokumenti,

rekords u informazzjoni oħra, u jeħtieġ li rekords tal-kompjuter

jiġu prodotti f’forma li fiha dawn jistgħu jkunu faċilment

aċċessibbli u meħuda mill-ispettur;

(e)

jieħu kampjuni ta’ prodotti, oġġetti jew materjali

bijoloġiċi;

(f)

iwettaq kwalunkwe eżami, investigazzjoni jew test;

u

(g)

jieħu ritratti, kejl jew reġistrazzjonijiet.

(2) Spettur jista’ jitlob kwalunkwe persuna li tipprovdi skont

il- ħtieġa għall-iskop tal-infurzar ta’ dawn ir-regolamenti u r-

Regolament tal-Kunsill kull -

(a)

assistenza;

(b)

dokumenti, reġistri jew informazzjoni oħra.

Nothing in these regulations must be taken as -

(a)

requiring a person to produce any document which

that person would be entitled to refuse to produce in any

proceedings in any court on the grounds that it is the subject of

legal professional privilege; or

(b)

authorising a person to take possession of any

document which is in the possession of a person who would be

so entitled.

Where an inspector exercises a power under these

regulations, it shall be an offence against these regulations for any

person to -

(a)

intentionally obstruct the inspector;

(b)

without reasonable excuse, fail to give the

inspector any information or assistance that the inspector may

reasonably require;

(c)

knowingly give false or misleading information to

the inspector;

(d)

without reasonable excuse, fail to produce a record

or document when reasonably required to do so by the inspector.

Where the competent authority believes that a Remedial

person has contravened any of these regulations or of the Council notice.

Regulation or following checks referred to in regulation 9 the

competent authority detects shortcomings, the Director of the said

competent authority may serve a remedial notice on such person in

accordance with sub-regulation (2).

(2) A remedial notice served upon the person in terms of sub-

regulation (1) shall

(a)

require the person upon whom it is served to take

such measures as the competent authority may determine in

order to remedy, or to prevent the continuation or repetition of,

any offence to which the remedial notice relates;

(b)

state the period within which any such requirement

is to be complied with.

(3) The period stated in the remedial notice for compliance

with any such requirement shall be such period as is reasonable in the

(4) The competent authority may at any time

(a)

withdraw the remedial notice;

(b)

extend the period for compliance with any

requirement of the remedial notice; or

(c)

modify the requirements of the remedial notice.

Where the competent authority has reasonable Administrative

fines.

cause to believe that -

(a)

an offence against these regulations has been

committed by any person; and

(b)

having regard to the previous conduct of the person

concerned, it would be appropriate to impose a penalty under

this regulation,

the competent authority may serve a notice in writing, in accordance

with sub-regulation (2), in the appropriate form to be served on that

(2) Without prejudice to the provisions of the Prevention and S.L. 549.97

Remedying of Environmental Damage Regulations, a notice under

sub-regulation (1) shall specify

(a)

the date and nature of the offence;

(b)

a summary of the facts upon which the allegation

that an offence has been committed is based, being a sufficient

summary to inform the person of the allegation against him;

(c)

any other matter that the competent authority

considers relevant to the imposition of a penalty;

(d)

the amount of penalty due.

(3) Any person on whom a notice under sub-regulation (1) is

served may, within thirty days after such service, by notice in writing

in the appropriate form served on the competent authority, require

that proceedings in respect of the alleged offence shall be dealt with

by the Court, in which case the following provisions shall apply

(a)

no further proceedings shall be taken under this

regulation by the competent authority; and

(b)

nothing in this regulation shall be construed as

preventing the institution of any proceedings in respect of the

alleged offence or the conviction of the person for the offence

by the Court or the imposition of any penalty or forfeiture under

this regulation upon such conviction.

(4) Any person on whom a notice under sub-regulation (1) is

served who does not wish that proceedings in respect of the alleged

offence be dealt with by the Court may by notice in writing served on

the competent authority -

(a)

admit the offence; and

(b)

pay the amount of the penalty to the competent

authority within thirty days after the notice of the penalty is

served or after such subsequent period as the Director may

determine.

(5) Where under this regulation a person admits an offence,

the competent authority shall impose a monetary penalty on that

person in respect of the offence amounting to one-third of the

maximum penalty to which the person would be liable if he were

convicted of the offence by the Court under these regulations.

(6) Any person upon whom a penalty is imposed under sub-

regulation (5) shall also be liable to pay for the expenses incurred for

the keeping and transport of the concerned specimen, and for any

other expense incurred or mitigation measures undertaken to remedy

such doings, damage and infringement.

(7) The penalty imposed under sub-regulation (5) shall be due

as a civil debt enforceable by the competent Court of civil jurisdiction

in favour of the Government of Malta and the declaration by the

person on whom the penalty is imposed that he admits the charge

shall constitute an executive title for the purposes of article 253 of the

Code of Organisation and Civil Procedure, in the same manner as if it Cap. 12.

were a judgment of the competent Court of civil jurisdiction.

(8) Notwithstanding any other provision of these regulations

or any other enactment, where an offence has been admitted under

this regulation, no charge may be laid in respect of the offence against

any person by whom it has been admitted.

(9) Where a person on whom a notice under sub-regulation (1)

is served does not, within thirty days after the notice is served upon

him, admit the offence, the Director shall institute proceedings or

cause proceedings to be instituted before the Court in respect of the

alleged offence.

(1)

Meta l-awtorità kompetenti jkollha raġuni biex Penali

amministrattiva.

temmen li -

(a)

reat kontra dawn ir-regolamenti ikun sar minn xi

persuna; u

(b)

wara li tikkunsidra l-aġir preċedenti tal-persuna

kkonċernata, ikun xieraq li tiġi imposta penali skont dan ir-

regolament,

l-awtorità kompetenti tista’ tinnotifika avviż bil-miktub, skont is-

subregolament (2), fil-għamla xierqa li għandu jiġi notifikat lil dik il-

persuna.

(2) Mingħajr

preġudizzju

għad-dispożizzjonijiet

tar-

Regolamenti dwar il-Prevenzjoni u r-Rimedju għal Danni Ambjentali, L.S. 549.97

avviż skont is-subregolament (1) għandhu jispeċifika

(a)

id-data u n-natura tar-reat;

(b)

sommarju tal-fatti li fuqhom l-allegazzjoni li sar

reat hi bbażata, li jkun sommarju suffiċjenti biex jinforma lill-

persuna tal-allegazzjoni kontriha;

(ċ)

kull kwistjoni oħra li l-awtorità kompetenti tqis

rilevanti għall-impożizzjoni ta’ penali;

(d)

l-ammont ta’ penali dovut.

(3) Kull persuna li lilha jiġi notifikat avviż taħt is-

subregolament (1) tista’, fi żmien tletin ġurnata wara dik in-notifika,

b’avviż bil-miktub fil-forma xierqa notifikat lill-awtorità kompetenti,

titlob li l-proċedimenti fir-rigward tar-reat allegat isiru trattati mill-

Qorti, f’liema każ għandhom japplikaw id-dispożizzjonijiet li ġejjin

(a)

ebda proċedimenti oħra ma għandhom jittieħdu

taħt dan ir-regolament mill-awtorità kompetenti; u

(b)

xejn f’dan ir-regolament m’għandhu jiġi interpretat

bħala li qed jipprevjeni li jittieħdu xi proċeduri fir-rigward tar-

reat allegat jew il-kundanna tal-persuna għar-reat mill-Qorti jew

l-impożizzjoni ta’ xi penali jew konfiska taħt dawn ir-

regolamenti ma’ tali kundanna.

(4) Kull persuna li lilha jiġi notifikat avviż taħt is-

subregolament (1) li ma tkunx tixtieq li l-proċedimenti fir-rigward

tar-reat allegat ikunu ttrattati mill-Qorti tista’ b’avviż bil-miktub

notifikat lill-awtorità kompetenti -

(a)

tammetti r-reat; u

(b)

tħallas l-ammont tal-penali lill-awtorità kompetenti

fi żmien tletin jum wara li l-avviż tal-penali jiġi notifikat jew

wara tali perjodu sussegwenti hekk kif id-Direttur jista’

jistabbilixxi.

(5) Fejn taħt dan ir-regolament persuna tammetti reat, l-

awtorità kompetenti għandha timponi penali monetarja fuq dik il-

persuna fir-rigward tar-reat li tammonta għal terz tal-piena massima li

għaliha l-persuna tkun suġġetta kieku kienet misjuba ħatja tar-reat

mill-Qorti skont dawn ir-regolamenti.

(6) Kull persuna li fuqha tiġi imposta penali taħt is-

subregolament (5) għandha tkun ukoll responsabbli biex tħallas l-

ispejjeż li jsiru għaż-żamma u t-trasport tal-kampjun ikkonċernat, u

għal kwalunkwe spejjeż oħra minfuqa jew miżuri ta’ mitigazzjoni

meħuda sabiex isir rimedju għal dawn ir-reati, ħsarat u ksur.

(7) Il-piena imposta taħt is-subregolament (5) tkin dovuta

bħala dejn ċivili infurzabbli mill-Qorti kompetenti ta’ ġurisdizzjoni

ċivili favur il-Gvern ta’ Malta u d-dikjarazzjoni mill-persuna li fuqha

l-piena hija imposta li tammetti l-akkuża għandha tikkostitwixxi

titolu eżekuttiv għall-finijiet tal-artikolu 253 tal-Kodiċi ta’

Organizzazzjoni u Proċedura Ċivili, bl-istess mod daqs li kieku kienet

sentenza tal-Qorti kompetenti ta’ ġurisdizzjoni ċivili.

(8) Minkejja kull disposizzjoni oħra ta’ dawn ir-regolamenti

jew xi liġi oħra, fejn it-twettiq ta’ reat ikun ġie ammess taħt dan ir-

regolament, ma tista ssir l-ebda akkuża fir-rigward tar-reat kontra xi

persuna li tkun ammettiet it-twettiq ta’ dak ir-reat.

(9) Meta persuna li lilha jkun ġie notifikat avviż taħt is-

subregolament (1) ma tammettix, fi żmien tletin jum wara li l-avviż

ikun ġie notifikat lilha, ir-reat, id-Direttur għandu jibda’ proċeduri

jew jara li jinbdew proċeduri quddiem il-Qorti fir-rigward tar-reat

allegat.

(1)

Any person -

Offences and

penalties

(a)

who fails to observe the provisions of these

regulations, or those of the Council Regulation, or fails to obey

a lawful order given by virtue of such regulations; or

(b)

who infringes any restriction, prohibition or need

imposed by these regulations or the Council Regulation or by

virtue thereof; or

(c)

who fails to observe any condition of mutually

agreed terms, prior informed consent or permit granted under

any provision of these regulations or under the Principal

Regulations; or

(d)

who acts in contravention of any provision of these

regulations or the Council Regulation; or

(e)

who makes a statement or presents information or

documentation, which such person knows to be false, for the

purpose of obtaining mutually agreed terms, prior informed

consent or a permit in terms of these regulations and, or the

Council Regulation, or

(f)

who conspires or attempts to conspire, aids or

attempts to aid, abets or attempts to abet, counsels or attempts to

counsel, procures or attempts to procure, any other person to

contravene the provisions of these regulations or the Council

Regulation, including any lawful order given by virtue of such

regulations, or to infringe any restriction, prohibition or need

imposed by such regulations or by virtue thereof;

(g)

who fails to comply with the provisions of Articles

4 and 7 of the Council Regulation (obligation to keep

information for twenty years after utilisation),

shall be guilty of an offence against these regulations.

(2) Any person who commits or attempts to commit an offence

against these regulations shall, on conviction, be liable

(a)

in the case of a first offence, to a fine (multa) of not

less than eight hundred euro (€800), but not exceeding four

thousand and six hundred and fifty-eight euro and seventy-five

cents (€4,658.75);

(b)

in the case of a second or subsequent offences, to a

fine (multa) of not less than six thousand euro (€6,000), but not

exceeding ten thousand euro (€10,000), or to imprisonment for

a period not exceeding two years, or to both such fine and

imprisonment

Provided that such fine shall in all cases be due to the

Government as a civil debt, and that where the person guilty of the

offence is a director, secretary or manager of a body corporate for the

economic benefit of which the offence was committed, such body

corporate shall be liable in solidum with the offender for the payment

of the said civil debt.

(3) Any person who has been found guilty of committing an

offence against these regulations or the Council Regulation shall also

be liable to pay for the expenses incurred for the keeping and

transport of the concerned specimen, and for any other expense

incurred or mitigation measures undertaken to remedy such doings,

damage and infringement.

(4) The provisions of articles 23 and 30(1) of the Criminal

Code shall, mutatis mutandis, apply to proceedings in respect of

offences against these regulations or the Council Regulation, so

however that the disqualification of obtaining prior informed consent

or of a permit under these regulations shall in no case be for less than

one year.

(5) Notwithstanding the provisions of article 370 of the

Criminal Code, proceedings for an offence against these regulations

or the Council Regulation shall be taken before the Court of

Magistrates (Malta) or the Court of Magistrates (Gozo), as the case

may be, and shall be in accordance with the provisions of the

Criminal Code regulating the procedure before the said courts as

courts of criminal judicature.

(6) Notwithstanding the provisions of the Criminal Code, the Cap. 9.

Attorney General shall always have a right of appeal to the Court of

Criminal Appeal from any judgement given by the Court of

Magistrates (Malta) or the Court of Magistrates (Gozo) in respect of

proceedings for any offence against these regulations.

Without prejudice to the provisions of the Council Interim

Regulation, the competent authority and the assistant authorities may measures

of emergencies.

for reasons of imminent threats to human, animal or plant health

adopt interim measures, as they deem fit in the circumstances.

The competent authority and the relevant assistant Special

authorities may, as appropriate, promote additional measures and considerations.

provisions which

(a)

consider the importance of genetic resources for

food and agriculture and their special role for food security;

(b)

encourage research which contributes to the

conservation and sustainable use of biological diversity; and

(c)

protect human and plant health.

Part VIII (Access to Genetic Resources) of the Flora, Substitutes Part

Fauna and Natural Habitats Protection Regulations shall be VIII

Flora, Fauna

substituted by the following

and Natural

Habitats

Protection

"PART VIII

Regulations.

ACCESS TO GENETIC RESOURCES

(1)

Without prejudice to the

Access to

genetic

Trade in Species of Fauna and Flora

resources.

Regulations, and the Access to Genetic

Resources and the Fair and Equitable Sharing of

Benefits arising from their Utilisation

Regulations, 2016 and the related regulations,

access to wild fauna and flora to countries other

than Malta shall be subject to prior informed

consent of the competent authority, provided

that wild birds and pathogens are excluded from

this provision.

B

(2) Access, where granted, shall be on

mutually agreed terms and subject to the

provisions of the Access to Genetic Resources

and the Fair and Equitable Sharing of Benefits

arising from their Utilisation Regulations, 2016.

For the purpose of these regulations,

Nature of

genetic

the genetic resources being provided by Malta

resources.

are only those genetic resources for which Malta

is the country of origin or that Malta is a country

providing genetic resources, having acquired

such genetic resources in accordance with the

provisions of the United Nations Convention on

Biological Diversity, done at Rio de Janeiro on

the fifth day of June 1992.".

€1.53