Study to support the evaluation of Regulation 2019/933

This is an open public procurement tender (not a grant) by the European Commission DG GROW for a six-month services contract to conduct a study supporting the evaluation of the SPC manufacturing waiver under Regulation 2019/933. The contract value is up to €149,000 and will be awarded on a best price-quality ratio with quality weighted 70% and price 30%. The study must collect and analyse administrative and market data (including national patent office notifications), stakeholder views and legal analysis, deliver an inception report at month 1, a draft report at month 5 and a final report at month 6, and hand over the underlying dataset. Tenders must be submitted electronically through the Funding and Tenders Portal by 16 November 2026 at 16:00 Brussels time and applicants must be registered in the Participant Register with a PIC.

What it will fund

A six-month contract to carry out a study to collect evidence and data to inform the Commission's evaluation of the SPC manufacturing waiver in Regulation 2019/933, including how national patent offices and courts apply the waiver, and preliminary analysis to feed the Commission's evaluation report.

Who can apply

Key administrative details

Deadlines & events

Submissions must be made electronically via the EU Funding & Tenders Portal. See procurement documents and templates (invitation, tender specifications, draft contract, financial form) on the Portal.

Contract documents require compliance with Commission security, data protection and confidentiality rules; security screening of contractor personnel may apply for access to Commission systems or premises.

Footnotes

1. 1All procurement documents, templates and the eSubmission link are available on the Funding & Tenders Portal at the call reference EC-GROW/2026/OP/0118.

This is an open public procurement tender launched by the European Commission, DG GROW (Internal Market, Industry, Entrepreneurship and SMEs) to contract a 6-month services study to collect evidence and data to inform the statutory evaluation of the SPC manufacturing waiver introduced into Regulation (EC) No 469/2009 by Regulation 2019/933. The study will support the Commission's evaluation duties under the Regulation and focus in particular on the application of the SPC manufacturing waiver by national patent offices and by relevant courts.

Eligibility, selection and submission practicalities

Eligibility and submission practicalities are set out in the Tender Specifications and Invitation to Tender. Key practical requirements include: registration in the Participant Register and use of PIC; submission exclusively via eSubmission (EU Login required); adherence to Annex 1 list of documents (Declaration on Honour, technical tender containing the methodology, team CVs and project references required for technical selection criteria T1–T3, and financial tender using Annex 6 format). Where subcontractors are identified (share > 20% or relied upon for selection criteria), commitment letters (Annex 5.1) must be included. Entities on whose capacities the tenderer relies must provide a commitment letter (Annex 5.2).

Evaluation focus and expected deliverables

The contracting authority expects an inception report (M1) detailing methodology and data collection approach, a draft report (M5), and a final report (M6) in Word plus five paper copies. The study must collect quantitative and qualitative data sufficient to inform evaluation criteria (effectiveness, efficiency, relevance, coherence and EU added value). Data sources should include national patent offices notifications of waiver use, industry federation inputs (e.g. EFPIA, Medicines for Europe), commercial data providers (e.g. IQVIA or equivalent) and company-level surveys/interviews. The final report must present the collected data, analysis, limitations, and supporting datasets. The contractor should assess impacts on manufacturing location decisions, EU day-one entry for generics/biosimilars, impacts on public health expenditure and access to medicines, and potential policy adjustments and their feasibility.

Summary: What is this opportunity about and why it matters

This procurement commissions an independent external study to gather and analyse empirical evidence to feed the Commission’s legally required evaluation of the SPC manufacturing waiver introduced by Regulation 2019/933. The waiver aims to allow EU-based manufacturers of generics and biosimilars to make SPC-protected products in the EU for export to third countries or to stockpile in the EU for sale immediately after SPC expiry. The study must collect quantitative administrative data (national patent office notifications), market and sales data, stakeholder views, and legal/case-law information, and produce a robust report that helps the Commission assess whether the waiver’s objectives have been met, including impacts on competitiveness, manufacturing location decisions, market entry timing for generics and biosimilars, public health and public expenditure, and any need for legislative or policy adjustments. The services will be procured under an open procedure; tenderers must be able to demonstrate relevant IP, market research, and data analysis expertise and to comply with security, IPR and data protection rules set in the draft contract and annexes.

Footnotes

1. 1Procurement documents and the submission portal are available on the Funding & Tenders Portal at the Tender Details page: ec.europa.eu

Executive Summary

This is a public procurement tender, not a grant. The European Commission, Directorate General for Internal Market, Industry, Entrepreneurship and SMEs, seeks one contractor to collect evidence and data and conduct preliminary analysis supporting the evaluation of the supplementary protection certificate manufacturing waiver introduced by Regulation 2019/933.

The contract concerns a specialised study at the intersection of intellectual property law, pharmaceutical markets, regulatory implementation, competition, public health and economic analysis. The strongest tenders are likely to combine practical knowledge of supplementary protection certificates, access to national patent office and industry data, stakeholder consultation capability, and rigorous quantitative and qualitative evaluation methods.

Regulation 2019/933 amended the EU supplementary protection certificate framework for medicinal products and introduced exceptions allowing EU based manufacturers of generics and biosimilars to manufacture protected products for export to countries where protection does not exist or has expired, and to manufacture and store products before certificate expiry for EU day one market entry.[FN:1]

The official opportunity page is Funding and Tenders Portal opportunity.

Opportunity Profile

Key procurement information

What the procurement is about

Policy and legal background

A supplementary protection certificate is an intellectual property right that can extend effective patent protection for certain medicinal products after lengthy marketing authorisation procedures. Regulation 2019/933 introduced an SPC manufacturing waiver into Regulation 469/2009.

The waiver has two principal components. The export waiver permits an EU based generic or biosimilar manufacturer to manufacture an SPC protected product in the EU for export to a third country where the corresponding protection does not exist or has expired. The stockpiling waiver permits manufacture and storage in the EU during a defined period before SPC expiry, enabling market entry in Member States immediately after protection ends.

The policy objectives include restoring competitiveness for EU manufacturers of generics and biosimilars, supporting growth and employment in the internal market, preventing manufacturing relocation outside the EU, facilitating EU day one market entry, improving access to medicines and potentially reducing public expenditure after protection expires.

Purpose of the study

The study will support the Commission's formal evaluation of the waiver. It will not itself constitute the Commission's final policy evaluation or decide whether the legislation should be amended. It must provide reliable evidence, data, preliminary analysis and stakeholder perspectives that the Commission can use in assessing whether the waiver has achieved its objectives.

The evaluation is expected to consider the standard Better Regulation criteria of effectiveness, efficiency, relevance, coherence and EU added value. It must also consider the specific statutory concerns relating to exports, stockpiling, access to medicines, public health expenditure, EU manufacturing, innovative medicine research and production, and whether the stockpiling period is sufficient, particularly for biosimilars.

Core research questions

The contractor will be expected to investigate the following questions and related issues:

Expected data sources and methodology

The tender specifications identify national patent offices as important sources because they receive waiver notifications and can provide official counts. Other relevant sources include industry associations representing innovative pharmaceutical companies and generic and biosimilar manufacturers, individual companies, national health authorities, specialist commercial databases and publicly available legal and market information.

The data must be sufficiently granular to support meaningful comparisons. At a minimum, the methodology should distinguish export and stockpiling waivers, small molecule products and biosimilars, SMEs and larger companies, Member States, relevant timing periods and, where possible, individual products and manufacturers.

A credible methodology should combine documentary and legal analysis, structured data collection, stakeholder interviews or surveys, validation of administrative data, market analysis and transparent treatment of confidentiality. The final report must explain the sources used, stakeholder consultations undertaken, quality assurance measures, data limitations, uncertainties and the reliability of each important evidence stream.

Required deliverables and timetable

The final report must be delivered digitally using the Commission's Word template and accompanied by five paper copies. It must contain the collected evidence, analysis and conclusions, with detailed data potentially placed in annexes. The final report must also include a methodological section covering data sources, consultations, quality assurance, limitations, uncertainties and reliability assessment.

Eligibility and who can apply

The open procedure allows any interested economic operator that meets the procurement requirements to submit a tender. Eligible tenderers may be natural persons, legal persons, groups of economic operators or international organisations, subject to the applicable EU procurement access rules and any relevant international agreement.

Third country participation is permitted where the country has a relevant procurement agreement with the European Union or is covered by the applicable World Trade Organization Agreement on Government Procurement, subject to the conditions of that agreement. Each tenderer must state its country of establishment and provide supporting evidence when required.

Applicants may tender as a sole economic operator or as a joint tender with other economic operators. A joint tender must appoint a group leader and provide the required agreement or power of attorney. Group members assume joint and several liability for performance of the contract as a whole.

Subcontracting is permitted. Identified subcontractors must be disclosed where the tenderer relies on their capacities or where their individual intended share exceeds 20 percent of the contract. Relevant commitment letters must be submitted. A tenderer may rely on the capacities of other entities, but must demonstrate that the required resources will actually be available and that the entities will perform the services for which their capacities are required.

The tender specifications indicate that the opportunity is not specifically reserved for SMEs. The procurement record marks the contract as not SME suitable, although SMEs may participate individually, in a consortium or as subcontractors if they satisfy the requirements.

Mandatory registration and submission conditions

Exclusion requirements

The tenderer and relevant involved entities must not be in an exclusion situation under the EU Financial Regulation. The declaration covers, among other matters, insolvency, unpaid taxes or social security contributions, grave professional misconduct, fraud, corruption, criminal organisation activity, money laundering, terrorist financing, trafficking, irregularities, serious contractual failures and obstruction of audits or investigations.

The declaration also covers persons with powers of representation, decision making or control, beneficial owners and, where relevant, persons assuming unlimited liability for the tenderer's debts. Tenderers must declare the absence of relevant conflicts of interest and restrictive measures and must confirm that the tender was prepared independently.

The required Declaration on Honour is included in the procurement documents. Supporting evidence, such as judicial extracts, tax certificates, social security certificates or equivalent documents, may be requested from the presumed successful tenderer or from any tenderer where needed. Applicants should prepare this evidence in advance because the contracting authority may impose a short deadline for submission.

Selection criteria

Legal and regulatory capacity

Tenderers may be natural or legal persons and are not required to adopt a specific legal form in order to submit a tender. The tender specifications state that no specific legal and regulatory capacity must be demonstrated beyond the general eligibility, access, exclusion and procurement requirements.

Economic and financial capacity

The consolidated average annual turnover of the tenderer must exceed €200,000 for the last two financial years. For a consortium, the capacities of the relevant involved entities may be combined for this criterion.

The contracting authority may request copies of profit and loss accounts for the last two closed financial years from each relevant entity, or appropriate bank statements if accounts are not available. The most recent financial year must have closed within the previous 18 months at the time of assessment.

Technical and professional capacity

The detailed technical and professional minimum requirements and evidence must be taken directly from section 3.2.3 and Annex 1 of the current tender specifications. The supplied opportunity record confirms that these requirements are part of the selection assessment, but the available extract does not reproduce the complete technical criteria. A bidder should therefore not rely solely on the summary metadata and should map every proposed expert, reference project, data source, methodological capability and relevant experience against the current official tender specifications before submission.

Likely capability profile

Award and evaluation

The contract will be awarded using the best price quality ratio. The published procurement data allocate 70 percent to quality and 30 percent to price. The quality score is therefore likely to be the decisive element, particularly because the assignment requires access to difficult data sources, legal and market expertise, robust stakeholder engagement and rapid delivery within six months.

The financial offer must follow the Commission's financial tender form. It provides for human resources, including roles, tasks, unit prices or daily rates and quantities or person days, together with other costs and a total price. The total offer must not exceed the maximum available budget of €149,000. A tender above the maximum budget is stated to be unacceptable.

A competitive price should be supported by a credible resource plan. Underpricing may create a quality and delivery risk if it does not provide enough expert days for cross Member State data collection, stakeholder consultations, legal analysis, data cleaning, quality assurance and report production.

Contract conditions and operational obligations

The procedure will result in a direct service contract. The draft contract governs performance, payments, confidentiality, intellectual property, checks and audits, security and other contractual obligations. The successful contractor remains responsible for the performance of the contract as a whole, including work performed by subcontractors.

The contract duration is at most six months. The tender specifications also state that, within three years after signature, the Commission may use a negotiated procedure to procure similar services from the contractor up to a maximum of 50 percent of the initial contract value, subject to satisfactory performance and budget availability. This is a possible future procurement and not guaranteed additional funding.

The contractor must comply with applicable Commission security requirements. Any associated financial burden, including security checks or clearances where applicable, is borne by the contractor. The contractor must support fraud prevention and detection, flow relevant obligations down to subcontractors and personnel, consider environmental requirements and observe EU principles on equality, diversity and non discrimination.

The Commission may offset established debts owed to the Union, the European Atomic Energy Community or an executive agency against payments due under the contract.

Key risks and bidder considerations

Recommended tender structure

Submission checklist

Important dates and source documents

The opportunity metadata contains an additional date of 1 January 2026, but the official call details and procurement documents identify 16 November 2026 at 16:00 Brussels time as the deadline for receipt of tenders. The later date should be treated as the operative tender deadline unless the portal publishes a formal correction.

Overall assessment

This is a focused, relatively low value but technically demanding Commission service contract. It is best suited to a research consultancy, university or specialist consortium with demonstrated EU pharmaceutical and intellectual property expertise, strong access to national and industry stakeholders, and the ability to deliver defensible evidence within six months.

The opportunity is attractive for organisations seeking a high visibility policy research assignment rather than grant financing. There is no grant funding rate, co financing percentage or reimbursement model. The successful tenderer is paid under the resulting service contract for the contracted services, subject to the final contract terms and accepted deliverables.

The principal competitive differentiators will be the credibility and availability of the proposed experts, access to reliable data, the ability to separate legal implementation from real economic impact, the quality of the stakeholder engagement design, and a realistic resource and delivery plan. Applicants should treat the full tender specifications and draft contract as controlling documents and use the portal's latest version before final submission.

Official legal context

Regulation 2019/933 is described in the EU legal material as promoting the competitiveness of the Union by enabling EU based manufacturers of generics and biosimilars to produce for export markets where protection does not exist or has expired, while requiring regular evaluation of the regime.[FN:1]

[FN:1]

Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019, amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products. Relevant legal text is available at Regulation 2019/933 legal text. The search record also identifies the regulation's objective as promoting Union competitiveness, growth, employment and supply of products under uniform conditions.7