ACCESS TO GENETIC RESOURCES AND THE FAIR AND EQUITABLE SHARING OF BENEFITS ARISING FROM THEIR UTILISATION

FROM THEIR UTILISATION

SUBSIDIARY LEGISLATION 549.111

ACCESS TO GENETIC RESOURCES AND THE FAIR

AND EQUITABLE SHARING OF BENEFITS

ARISING FROM THEIR UTILISATION

REGULATIONS

8th November, 2016

LEGAL NOTICE 379 of 2016.

The title of these regulations is the Access to Genetic

Resources and the Fair and Equitable Sharing of Benefits arising

from their Utilisation Regulations.

(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

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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

down in the Convention on Biological Diversity (Incorporation)

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

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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

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

c o n s e n t , i s s u i n g i n t e r n a t i o n a l ly r e c o g n i s e d c e r t i f i c a t e s o f

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

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(a) the Environment and Resources Authority for wildlife,

as laid down under the Environment Protection Act,

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.

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

r e s ou rc e s , t he gr a n ti ng o f pr io r i nf or m e d c on s e n ts and t he

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.

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(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

with genetic resources held by local communities shall require a

joint 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

m a y c o n su l t t h e a s s i s t a n t a u t h o r i t y a t a n y t i m e d u r i n g t h e

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

utilisation of genetic resources, hereinafter referred to as "the

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

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;

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(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

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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 the

Member State under Article 13 of the Council Regulation.

The competent authority may impose a requirement upon a

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

regulations and may also impose an administrative penalty.

(1) Subject to sub-regulations (2) and (3), administrative

fines may be imposed in relation to a failure to comply with any of

the following provisions

(a) Article 4(1) of the Council Regulation (obligation 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).

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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.

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(1) An inspector who has entered premises in exercise 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.

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.

(1) Where the competent authority believes that a person

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has contravened any of these r egulations or of the Council

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 circumstances.

(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.

(1) Where the competent authority has reasonable 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 person.

(2) Without prejudice to the provisions of the Prevention and

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

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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

ju r i s di c t i on i n f a v o u r o f th e Go v e r n m e n t o f M a l t a an d t h e

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 Organization and Civil Procedure, in

the same manner as if it 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.

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(1) Any person -

(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

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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

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

Regulation, the competent authority and the assistant authorities

may 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

authorities may, as appropriate, promote additional measures and

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.