Data protection: pesticide product authorisation
- What 'data protection' is
- Data protection periods under applicable legislation
- Applications for a new product citing data for which data protection has expired
- Vertebrate data sharing provisions
- Letters of access
What 'data protection' is
Data protection is a period of exclusivity for data owners who have invested in generating data, tests and studies to support product authorisations and active approval/renewal.
Individual studies can only be subject to 1 period of data protection, regardless of how many times the study has been submitted.
Where appropriate, data submitted in support of an application and used to make a regulatory decision will be protected, in line with the provisions of the legislation under which the application was evaluated.
During the data protection period, a third party cannot use protected data in support of an application for authorisation of their product, without the permission of the data owner through a letter of access. An exception to this is, where data sharing provisions are in place, to avoid duplicate studies on vertebrates.
Once the data protection period has expired, HSE can use the data on behalf of a third party without gaining permission to do so from the data owner, although the data remains confidential to the data owner.
Since 2011, 3 systems have applied in the UK, reflecting the national rules under the Control of Pesticides Regulations 1986 (COPR)) and the European systems (under Council Directive 91/414/EEC and Regulation (EC) No 1107/2009).
The COPR and Council Directive 91/414/EEC (as implemented in the UK via the Plant Protection Products Regulations 2005 (PPPR)) systems are similar in many ways. The main points of each are described below. The system under Regulation (EC) No 1107/2009 (as implemented via PPPR 2011) attempted to simplify the procedure, data protection is repatriated to Member States.
These summaries are intended only as a guide, please contact us for advice if you have any queries.
Under COPR and PPPR 2005, data protection only applies to data supporting a commercial authorisation. Data submitted in support of trials permits, import tolerances and adjuvant list entries are not covered under these arrangements. These data will not be used for the benefit of any third party applications, without a letter of access from the data holder.
Under Regulation (EC) No 1107/2009 data protection applies to data supporting a commercial authorisation and data submitted for the extensions of authorisation for minor uses (off-labels). Once future regulations are in place in accordance with Article 26, data protection shall also apply to safeners, synergists and adjuvants.
It is important that all applicants clarify the position on data access in the covering letter with the application form. The applicant should also identify in their covering letter whether they previously sought data lists from HSE.
Find out if data submitted to support an application has been protected
When HSE issue a product authorisation, we will advise the applicant in the accompanying letter whether any data submitted with the application has been granted any protection. We may include a summary table of the data submitted in Part A of the registration report and detail the periods of protection associated with each study.
This information is only provided to the data owners and is not publicly available unless requested under Article 60 of Regulation (EC) No 1107/2009.
Active substance data submitted for the purposes of Annex I inclusion under Council Directive 91/414/EEC or for Approval under Regulation (EC) No 1107/2009, is listed in the Review Report for that active substance.
Data protection periods under applicable legislation
Data protection periods for products considered under COPR
The arrangements for data protection under COPR [Control of Pesticide Regulations 1986] were first announced in 1991. They were agreed by Ministers and structured so as to mirror the, then developing, EU system.
The protection periods applied to data submitted and used to support COPR approvals are shown in the table below
| Type of data | Period of protection |
|---|---|
| Active substance | 10 years from the date of first approval of the first product containing that active |
| Active substance data pre-COPR | Were protected until 10 years from the start of COPR so unprotected since 6 October 1996 |
| Active substance data to support the continuing approval of that active, for example provisional to full approval | 5 years from the date of new approval (like that issued following evaluation of the additional data) or until original expiry date for active data, whichever is the longer |
| Active substance data to support continuing approval – UK reviews | 5 years from the date of official decision (departmental agreement for the review recommendations) or until original expiry date for active data, whichever is the longer |
| Product data | 10 years from date of first approval of the product |
| Specific off label data under COPR | 10 years from the date of specific off-label approval [now known as extension of authorisation for minor use] was issued (this was a later clarification) |
| Product data pre-COPR | Protected until 10 years from start of COPR – sounprotected since 6 October 1996 |
| Product/active substance data supporting a new use of an existing product | 10 years from date of first approval of product (so no further protection for new use data) |
| Product data to support formulation change (resulting in a new product) | 10 years from date of approval of new product |
The data protection periods for products considered under PPPR 2005
The rules for data protection under Council Directive 91/414/EEC are set out in the legislation under Article 13 of the directive. The protection periods applied to data submitted and used to support PPPR 2005 approvals are summarised in the table below.
| Type of data | Period of protection |
|---|---|
| Active substance data for a new active substance | 10 years from the date of Annex I inclusion – protected data will be listed in the Review Report. The same period of protection applies across all Member States. |
| Active substance data for existing active substances | 5 years from the date of Annex I inclusion – protected data will be listed in the Review Report and protected across all Member States. Any data used nationally prior to the review does not gain the 5 years protection |
| Active substance data to maintain or amend the Annex I inclusion | 5 years from the date of the revised Annex I inclusion. This only applies to further, necessary information to support the continued orvaried inclusion of an active substance on Annex I |
| Product data following Annex I inclusion | 10 years from date of first approval of any new product in any Member State following Annex I inclusion. |
| Product data required to reregister a product following Annex I inclusion | In line with original, national, expiry date for the product – no additional protection is given to new data required under Annex III of the Directive unless there has been a change in form of the product |
| Product data supporting a new use, including extensions of use, of an existing product | Following Annex I inclusion, 10 years from date of approval for use (unlike COPR, new use data gain protection in their own right) |
| Product data to support formulation change (resulting in a new product) | Following Annex I inclusion, 10 years from date of approval for new product |
The data protection periods for products considered under Regulation (EC) No 1107/2009
The rules for data protection under Regulation (EC) 1107/2009 are set out under Article 59. In order to be eligible for data protection the tests and study reports must be certified as compliant with the principles of good laboratory practice (GLP ) or good experimental practice (GEP) and the applicant must claim data protection for the tests and studies at the time of application.
The protection periods applied to data submitted and used to support authorisations (including extensions for minor uses as defined in Article 51(1)) under Regulation (EC) 1107/2009 are summarised in the table below.
| Type of data | Period of protection |
|---|---|
| Active substance and product data necessary for authorisation or amendment of an authorisation | 10 years from the date of the authorisation in each Member State, therefore different periods of protection will apply in each Member State. This will be extended to 13 years for products covered by Article 47 (low risk plant protection products). The above periods shall be extended by 3 months for each minor use as defined in Article 51(1). The minor use application must be made by the product authorisation holder and the minor use must be supported by data and not based on extrapolation. The application must be made within 5 years of the first product authorisation in the UK and the total data protection period for the product may not exceed 13 years which is extended to 15 years for products covered by Article 47. |
| Active substance and product data for renewal or review of an authorisation | 30 months from the date of the first authorisation in each Member State. This only applies to tests or studies necessary to support the continued/varied approval. |
| Data submitted in support of minor uses | 10 years from the date of the first product authorisation in each Member State, therefore different periods of protection will apply in each Member States. This will be extended to 13 years for products covered by Article 47 (low risk plant protection products). |
These data protection rules applied to all applications made from 14 June 2011 and considered under Regulation (EC) No 1107/2009). Transitional measures in Article 80 allowed for Council Directive 91/414/EEC data protection rules (Articles 13(1) to 13(4)) to continue for active substances that were considered under Council Directive 91/414/EEC rules (such as those active substances that were included on Annex I or approved by virtue of Article 80(1)). However, as Article 80(2) also refers to Article 13(4) which refers to product data protection this allows Council Directive 91/414/EEC data protection for products containing active substances considered under Council Directive 91/414/EEC to continue.
Applications for a new product citing data for which data protection has expired
Article 34 of Regulation (EC) No 1107/2009 exempts applicants from the need to supply supporting data when:
- applicants can demonstrate that the competent authority has already assessed relevant supporting studies to support authorisation
- the data protection period for all relevant supporting active substance has expired at the time of application
- the data protection period for all reference product studies has expired at the time of application
Find out more about applying for a new product based on unprotected data and HSE data protection checks.
Vertebrate data sharing provisions
The following vertebrate data sharing arrangements apply to all applications received from 14 June 2011.
In order to reduce the number of tests carried out on vertebrate animals, Article 62 of Regulation (EC) No 1107/2009 (legislation.gov.uk) lays down rules for sharing tests and studies involving vertebrate animals for both active substance and product data.
Article 62 (2) states that a competent authority shall not accept duplicate tests and studies on vertebrate animals, nor those initiated where conventional (calculation) methods could reasonably have been used. If vertebrate studies are submitted, they must be justified fully (see Article 8 (1) (d)). HSE will not accept studies without such justification from the applicant.
Article 62(3) requires the prospective applicant and data owners to make 'every effort' to ensure that they share vertebrate tests and studies, and specifies that the costs must be determined in a 'fair, transparent and non-discriminatory way'. This is an obligation on the two parties concerned. HSE is not in a position to adjudicate in their negotiations and will not become involved in considering whether 'every effort' has been made or in determining the costs payable to the data owners. Where necessary, the parties may wish to consider participating in arbitration as an alternative dispute resolution procedure to resolve the terms of sharing vertebrate studies. HSE agreed the scheme with CEDR Solve for this purpose.
Article 62 allows the competent authority to use vertebrate studies for an application where the applicant has not been able to reach agreement on sharing the data with the data owners. Where HSE has evidence of negotiations and is informed by a prospective applicant that no agreement can be reached, HSE will access the relevant vertebrate studies to support the application for authorisation. In these cases, data owners are able to claim from the prospective applicant a fair share of the costs of those studies and the data owners may issue proceedings in order to recover those costs. Prospective applicants may have to bear legal costs arising from any such proceedings.
Council Directive 86/609/EEC defines the type of tests that are covered by the vertebrate data sharing arrangements. On this basis, HSE consider that field monitoring data (e.g. such as that conducted for higher tier bird and mammal assessments) are not within the scope of the vertebrate data sharing arrangements.
Acceptance of duplicate studies under specific circumstances
HSE can accept vertebrate studies generated prior to 14 June 2011, providing justification is submitted that demonstrates that the studies were generated in good faith and on the basis that no alternative approaches were available, for example following previous failed attempts to negotiate access under the previous legislation. We may also accept arguments for the submission of studies generated to support other regulatory regimes.
Avoidance of duplicate testing – provision of data lists and data sharing negotiations
Article 61 of the Regulation introduces general rules on the avoidance of duplicate testing. It requires prospective applicants for product authorisation to consult details of products authorised by competent authorities. Where authorised products contain the same active substance, safeners or synergist as the proposed product, applicants must request from the competent authority a list of test and study reports such as those prepared in accordance with Article 60 studies. Prospective applicants must also provide to the competent authority, all data regarding the identity and impurities of the active substance(s) and evidence that an application for authorisation is intended.
Requests for data lists from HSE should be made to PPP Enquiries. Once HSE is satisfied that the prospective applicant intends to apply for product authorisation, or the renewal thereof, HSE will provide the list of studies, the name and address of the authorisation holder(s) (data owners) and at the same time alert the data owners of the name and address of the prospective applicant.
It is the responsibility of the prospective applicant and data owners to take all reasonable steps to reach an agreement on sharing of any tests and study reports. It is important that the context of those negotiations are clear to all parties. Access negotiations conducted historically may not be relevant to new product application submissions.
Avoidance of duplicate testing – submission of applications
Sometimes, prospective applicants obtain lists of protected studies from other sources (for example HSE or EU Commission website or competent authority in an EU member state) and may contact the data owners directly without involving HSE. In those cases, the first time HSE will be aware that negotiations are ongoing is when an application for authorisation is received. In these circumstances, applicants must confirm that they have taken the appropriate steps to negotiate access with the data owners. They should provide either the letter of access (for vertebrate studies only) or confirm that the two parties have failed to reach an agreement to share the data.
Once HSE accepts an application where the applicant identifies that negotiations have failed, HSE will write to the data owners to confirm that an application has been accepted on this basis.
The applicant should identify in their covering letter whether they previously sought data lists and clarify the position on data access.
Letters of access
A letter of access allows HSE to use protected active substance or formulation data which are owned by a third party. Access can be granted to specific studies or an entire data package.