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Interim National Reports on the Implementation of the Nagoya Protocol
(NR)
published: 20 Dec 2017
last updated: 14 Feb 2018
No country selected.
Malta Interim national report on the implementation of the Nagoya Protocol
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Competent National Authority:
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ABSCH-CNA-MT-208507-5
This document has been updated. This is not the latest published version.
Click here to view the latest version of the record.
Competent National Authority:Plant Health Directorate (Director) ()110, Annibale Preca StreetLija,
LJA1915, MaltaPhone: (00356) 2292 6501, (00356) 2292 6500,Fax:Email: sharlo.camilleri@gov.mt,Website:
To view the current National Focal Point information, click
here.
Yes
No specific difficulties or challenges have been identified.
Yes
No specific difficulties or challenges have been identified.
Adoption of Regulation (EU) 511/2014 on compliance measures for the users from the Nagoya Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union;
Contribution to Commission Implementing Regulation (EU) 2015/1866 laying down detailed rules for the implementation of Regulation (EU) 511/2014 as regards register of collections monitoring user compliance and best practices;
Contribution to Commission Notice – Guidance document on the scope of application and core obligations of Regulation (EU) 511/2014 (2016/C 313/1)
Malta is bound to apply the EU ABS Regulations as a member state of the European Union. On 15 November 2016, Malta has applied Subsidiary Legislation 549.111 of the Laws of Malta which aims to implement the Nagoya Protocol, the EU ABS Regulation and Article 15 of the CBD at national level.
Yes
No specific difficulties or challenges have been identified.
Yes
One national competent authority has been assigned in Malta to oversee matters dealing with access and benefit sharing; this authority is assisted by three further assistant authorities which may grant access to genetic resources through prior informed consent (PIC) and provide support in the carrying out of checks and managing genetic resource collections, whenever they are available.
No selection made
Yes
Information about permits has been provided to the ABSCH so that IRCCs may be produced. The actual permits and MAT documents have not been uploaded since these identify individuals, companies and genetic resources which may potentially reveal information about R&D projects that are subject to confidentiality requests by the same applicants.
Not applicable, since no access requirements are in place
Yes
Information about permits has been provided to the ABSCH so that IRCCs may be produced. The actual permits or their equivalent documents have not been uploaded since these identify individuals, companies and genetic resources which may potentially reveal information about R&D projects that are subject to confidentiality requests by the same applicants
Yes
The main challenge in defining the checkpoints in the EU concerned striking a balance between having effective checkpoints covering as wide a range of ABS relevant activities as possible, while avoiding the creation of unnecessary administrative burden.
In Malta there are two checkpoints established at EU level:
1/ The Plant Protection Directorate, acting as the ABS Competent National Authority designated under EU Regulation 511/2014 is tasked to gather due diligence declarations from EU researchers; all recipients of research funding where such research involves utilisation of genetic resources and traditional knowledge associated with genetic resources are to be requested either by the Commission or by a Member State (depending on source of funding) to declare that they exercised due diligence in accordance with Article 4 of the EU ABS Regulation; in line with the Commission Implementing Regulation the researchers need to submit a due diligence declaration to the national competent authorities if the user is established in the same country; a template for such declaration is defined in the Commission Implementing Regulation in Annex II; the competent national authority transfers then information (provided it is not confidential) to the ABS Clearing House; alternatively, in case crucial information for publishing of checkpoint communiqué is indicated as confidential and CPC cannot be published they contact the competent national authorities of the country providing genetic resources.
2/ the same competent national authority designated under Regulation 511/2014 is tasked to gather due diligence declarations at the final stage of a product development from all users; a template for such declaration is defined in the Commission Implementing Regulation (Annex III); specific events triggering submission of the declaration are defined in Article 6 of the Commission Implementing Regulation. Competent national authorities transfer information contained in the declaration (provided it is not confidential) to ABS Clearing House; alternatively, in case crucial information for publishing of checkpoint communiqué is indicated as confidential and CPC cannot be published, they contact the competent national authorities of the country providing genetic resources.
Under the Laws of Malta, three assistant authorities have been designated to support the competent authority. Assistant authorities may grant access to genetic resources in areas of their competence, and comprise the following:
(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.
No additional information provided
Yes
Access is granted by the competent national authority in conjunction with its assistant authorities depending on the nature of the genetic resource, further to consultation with an impartial advisory committee in accordance with Regulations 4(3), 5, and 11(1) of Subsidiary Legislation 549.111 of the Laws of Malta.
Yes
Users requesting access and utilization of genetic resources are guided through the application process by Regulations 7(1-4) of S.L. 549.111; further guidelines are provided by the national competent authority through an information document made available through the authority’s website: [https://agriculture.gov.mt/en/phd/] or which has directly been distributed through a mailing list to local businesses or parties of interest.
Applications forms for the access (use) of species protected under the Environment Protection Act (barring birds) are available on the Environment and Resources Authority (ERA) website. [https://era.org.mt/en/Pages/Nature-Permits.aspx]
Yes
The conditions for requesting access for utilization of genetic resources are stipulated in Regulation 7 of S.L. 549.111; once a decision concerning access is reached by the national competent authority this is communicated in writing to the applicant. Additionally, prior informed consent is granted through an official access permit.
If access is not granted through the provisions of the S.L. 549.111, the applicant is informed on the reasons for such a refusal. Moreover, the details of persons having been granted a permit together with the conditions imposed are maintained in a register which is available for public inspection.
Yes
The provision of a permit or certificate of compliance to the user is required by Regulation 5(4) of S.L. 549.111.
Yes
MAT are required by Regulation 5(2) of S.L. 549.111 for the utilization of genetic resources for which PIC is required; the MATs, among other conditions, contain terms for dispute settlement; terms on benefit-sharing, including in relation to intellectual property rights; terms on subsequent third-party use; and terms on changes of intent, where applicable.
Yes
Yes
No additional information provided
Yes
Article 4(1) of the EU ABS Regulation provides that “users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilise have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements.”
Regulation 2(4) and 22(1)(a and d) of S.L. 549.111 mandates the direct application of the EU ABS Regulations; specific reference is made to Article 4(2) which requires that genetic resources and traditional knowledge associated with genetic resources may only be transferred and utilised in accordance with mutually agreed terms if they are required by applicable legislation or regulatory requirements.
Regulation 5(3) of S.L. 549.111 ensures that benefits arising from the use of Malta’s genetic resources are shared with the provider country.
Yes
Article 4(1) of the EU ABS Regulation provides that “users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilise have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements.”
Regulation 6 of S.L. 549.111 addresses the utilization of traditional knowledge. Utilization of such knowledge can be subjected to the same regulatory requirements as utilization of genetic resources or their derivatives.
Yes
Article 4(1) of the EU ABS Regulation provides that “users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilise have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements.”
Regulation 6 of S.L. 549.111 addresses the utilization of traditional knowledge and the sharing of benefits with its providers. Utilization of such knowledge can be subjected to the same regulatory requirements as utilization of genetic resources or their derivatives.
No additional information provided
Yes
Yes
Adoption of Regulation (EU) 511/2014 on compliance measrues for the users from the Nagoya Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union; entered into force on 12 October 2014;
Contribution to Commission Implementing Regulation (EU) 2015/1866 laying down detailed rules for the implementation of Regulation (EU) 511/2014 as regards register of collections, monitoring user compliance and best practices; entered into force on 9 November 2015;
Adoption of Subsidiary Legislation 549.111 which entered into force on 15 November 2016. Regulations 5 of S.L. 549.111 prohibits users to access and utilize genetic resources without prior informed consent (PIC), mutually agreed terms (MAT) and internationally recognized certificate of compliance (IRCC). Regulations 9(2), and 15 provide to the competent national authority powers to carry out checks and inspection. Regulation 21 and 22 envisage administrative sanctions in situations of non-compliance.
No
Yes
Yes
No
No need for cooperation was identified.
Both the EU ABS Regulation (511/2014) and Commission Implementing Regulation (2015/1866) are applicable equally to genetic resources and to traditional knowledge associated with genetic resources; these Regulations provide for the legal framework to deal with issues of non-compliance.
Under Subsidiary Legislation 549.111, utilization of traditional knowledge is subject to similar conditions as the utilization of genetic resources.
Yes
EU ABS Regulation (Regulation (EU) No 511/2014) requires that users in the EU exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilise have been accessed in accordance with applicable access and benefit sharing legislation or regulatory requirements, and that benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements. In line with Article 7 of the EU ABS Regulation (and as detailed in the Commission Implementing Regulation) users need to provide certain information to the designated Competent National Authority in Malta, including information related to PIC, the source of genetic resource, and the establishment of MAT, among others.
Yes
In addition to the above, the designated Competent National Authority in Malta is obliged, based on Article 9 of the EU ABS Regulation, to perform checks on user compliance in accordance with periodically revised risk-based plan.
Yes
Other
The checkpoint may be triggered at a different stage than when the permit for access is granted in accordance with EU law. The checkpoint communique will be transmitted at a later stage during the course of the project.
0
Yes
The MAT establishes conditions on the transfer of genetic material or the products arising from its utilization, so that: (i) the conditions of the MAT are obeyed if transfer of the genetic material or the products of its utilization to other parties is carried out, (ii) the national competent authority is notified in case of change of utilization or identities of the users upon transfer, and (iii) providers are obliged to transfer all required information to the (subsequent) user. The MAT is established based on PIC, and information on the source of the genetic resource is also included in it.
Yes
According to Article 13 of the EU ABS Regulation (Regulation (EU) No 511/2014) both the Commission and Member States are obliged as appropriate to promote the development and use of cost-effective communication tools and systems in support of monitoring and tracking the utilisation of genetic resources and traditional knowledge associated by genetic resources by collections and users.
No additional information provided
Not applicable, since no access requirements are in place
Yes
The MATs which are produced by the the designated Competent National Authority include clauses that establish measures for dispute resolution. Disputes are to be primarily resolved by friendly negotiation; if disputes cannot be resolved amicably, then arbitration procedures under the Laws of Malta may be initiated.
Yes
Arbitration procedures may be sought through procedures under the Laws of Malta if friendly negotiations are unproductive.
Yes
Reference to the Arbitration Act, Cap. 387 of the Laws of Malta is made in the MAT.
Yes
The MAT requires the provider and the recipient of the genetic resource to take all necessary measures to ensure compliance with all the applicable laws, rules, guidelines and regulations of the country providing the resource and the country where the resource is utilised.
No additional information provided
Yes
The application process for research follows a simplified procedure, and the benefit sharing arrangements are focused on the sharing of knowledge gained. Provisions in the eventuality of change of intent are included in the agreement entered upon access to the genetic resource.
Yes
Article 4(8) of the EU ABS Regulation provides for a short temporal derogation from the duties of its Article 4(3) and 4(5) for users acquiring a genetic resource that is determined to be, or is determined as likely to be, the causing pathogen of a present or imminent public health emergency of international concern.
Regulation 23 of S.L. 549.111 of the Laws of Malta enables the national competent authority to adopt interim measures in case of imminent threats to human, animal or plant health.
Yes
Regulation 23 of S.L. 549.111 of the Laws of Malta enables the national competent authority to adopt interim measures in case of imminent threats to human, animal or plant health.
Yes
Article 4(4) of the EU ABS Regulation stipulates that users acquiring Plant Genetic Resources for Food and Agriculture (PGRFA) in a country that is a Party to the Nagoya Protocol which has determined that PGRFA under its management and control and in the public domain, not contained in Annex I to the International Treaty on Plant Genetic Resources for Food and Agriculture, will also be subject to the terms and conditions of the standard material transfer agreement for the purpose set out under the ITPGRFA, shall be considered to have exercised due diligence in accordance with paragraph 3 of this Article.
Regulation 24 of S.L. 549.111 of the Laws of Malta enables the national competent authority to adopt additional measures to promote the role of genetic resources for food security and encourage research for conservation and sustainability.
No additional information provided
No
Not applicable
No selection made
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Not applicable
Not applicable
Not applicable
Not applicable
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No selection made
Not applicable
Not applicable
No additional information provided.
Yes
In line with Article 13 of the EU ABS Regulation (Regulation (EU) No 511/2014) the Commission and the Member States shall encourage users and providers to direct benefits from the utilisation of genetic resources towards the conservation of biological diversity and the sustainable use of its components in accordance with the provisions of the Convention.
Mutually agreed terms established by Malta’s CNA will attempt to incorporate non-commercial and commercial benefit sharing clauses. Non-commercial benefits encourage the sharing of knowledge, which may contribute to the deeper understanding of the national genetic resources for application towards conservation and sustainability. Commercial benefits are directed towards a national fund which role is to support in projects contributing to conservation and sustainability.
No answer provided
The application of the Nagoya Protocol for Malta is still in its early stages and there is insufficient experience to enable to discuss any tangible benefits related to conservation and sustainable use of biodiversity.
No additional information provided.
Yes
Malta shares no land or sea territory with other parties to the Nagoya Protocol. No official legal provisions exist on transboundary cooperation in terms of Article 11.1, however the national competent authority does not exclude cooperation on a case-by-case basis. In line with Article 12 of the EU ABS Regulation, Malta is obliged to cooperate with other EU Member States where required.
Not applicable, since there are no indigenous and local communities in my country
No selection made
No additional information provided
Yes
In line with Article 13 of the EU ABS Regulation (Regulation (EU) No 511/2014) the Commission and the Member States shall encourage development of, among others, model contractual clauses, guidelines and best practices, particularly when they would benefit academics, universities, non-commercial researchers and small and medium-sized enterprises;
Furthermore, for establishing mutually agreed terms, Malta’s CNA makes use of a template contract which may be adapted depending on the scope of the utilization and benefits negotiated.
Yes
In line with Article 13 of the EU ABS Regulation (Regulation (EU) No 511/2014) the Commission and the Member States shall encourage development of sectoral codes of conduct, model contractual clauses, guidelines and best practices, particularly when they would benefit academics, university and non-commercial researchers and small and medium-sized enterprises;
No additional information provided
Yes
No
Yes
Yes
Among the measures listed in Appendix I of Decision NP 1/8. Malta has fulfilled a substantial portion of the short and medium term measures in Key areas 1-5; Long term measures can not immediately be addressed as these rely on experience which is gained as the Nagoya Protocol is applied over time.
Malta accessed the Protocol on 1 December 2016, and the Government of Malta through its various authorities continues to raise awareness about the importance of national genetic resources. The CNA functions as a checkpoint and has established a legal system which aims to implement and comply with the Protocol as well as ensure cooperation between different authorities, particularly through an Access and Benefit Sharing Advisory Committee which brings together experts from various line departments to provide advice and support on decisions taken by the CNA; the legal system provides a system for granting of PICs and establish MATs; MATs are drafted by legal expertise and generally used as templates to establish terms of use and benefit sharing.
The CNA has also initiated the mapping of the potential users to enable targeted implementation of the Protocol. A national database of genetic resources of historical or traditional importance and owned by private or public entities is also being developed in the long term. Periodic reporting is required by those entities that are given PIC and with which MATs are set in place, to facilitate desktop monitoring; measures for on-the-spot inspections and verifications are also in place through national law as well as MATs. Access to justice is instilled in Malta’s national laws and measures exist for its application in ABS infringement cases under Subsidiary Legislation 549.111 which applies the Nagoya Protocol at national level.
No
No
No additional information provided
No
No additional information provided
No specific difficulties were identified during the accession process.
No
The implementation of the Protocol is not expected to demand large amounts of funding to date. No specific funds have been allocated to the implementation of the Protocol, and funds are mobilized on a case-by-case basis as required. The national competent authority will attempt to make use of the capacities and resources already available at its disposal, where possible.
No
No information provided
No information provided
Yes
Less than 5
No information provided
No information provided
