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Work programme 2017

WC500221614

Risk MAHs/pharmaceutical

Risk MAHs/pharmaceutical industry with the policy Stakeholder relationships Failure to meet stakeholder expectations Mitigating actions and controls • Information sessions with industry • Consultation with stakeholders • Issuing of non-compliance statements Planned: • Targeted consultations with stakeholders • Annual report on implementation experience, including non-compliance data In place: • Framework for interaction with patients and consumers • Frameworks for interaction with healthcare professionals • Framework for interaction with academia • SME surveys and other initiatives • Communication perception surveys • Targeted stakeholder meetings • Tools including website/media monitoring/google alerts In progress: • Framework for interaction with industry stakeholders Planned: • Online programme In light of the outcome of the UK referendum on the EU membership, the Agency is conducting impact and risk assessment. Along other aspects, the main risks identified are as follows: Risk Loss of UK expertise in the scientific work Loss of existing staff and inability to recruit new staff, resulting in loss of professional competencies and knowledge Currency volatility Impact UK experts constitute 15% of the Agency's expert base and conduct around 20% of the scientific work. Losing these resources will lead to - Significant increase in workload for EU experts, requiring remedial actions to address workload and capacity aspects - Potential loss of specific expertise, requiring remedial actions to ensure that the quality of scientific output is not affected Due to high uncertainty, - Current EMA staff may choose to leave Agency for other organisations in order to re-acquire longer term stability and perspective - The Agency is not able to provide longer term stability when recruiting new employees, and as such may fail to attract competent experts to fulfil In case the Agency would need to relocate, some staff will not be willing to relocate and the Agency may face significant loss of staff/expertise once the new seat becomes know. High fluctuations of GBP to EUR exchange rate introduce instability in the Agency's cash flow and budget. Work programme 2017 EMA/583016/2016 Page 116/123

Annex 5: Procurement plan 2017 Activity statement: Software for Innovation, Diversity and Evolution Objective: See Work programme 2017, heading 4 Budget: € 19,000,000 of which €3,500,000 operational and €15,500,000 administrative Financial year: 2018-2022 Description of action: Inter-institutional tender procedure to be run by European Commission (DIGIT) for software purchases Type of contract: European Commission tender procedure, Framework Contract implemented by Specific Contracts and Purchase Orders Number of contracts: 1 Indicative timeframe for contract: Expected to be signed in 2018 Indicative timeframe for procurement: Expected to be launched in 2017 Indicative budget for procurement: € 19,000,000 Legal basis: Article 57 of Regulation 726/2004 as amended by Regulation (EU) No 1235/2010 Budget line: B2110, B2114, B3105 Activity statement: Consultancy services to support the Agency's on-line communications activities Objective: See Work programme 2017, heading 4 Budget: € 3,000,000 Financial year: 2018-2022 Description of action: Consultancy services to support the Agency's on-line communications activities Type of contract: Framework contract to be implemented by Specific Contracts Number of contracts: 1 Framework contract Indicative timeframe for contract: Expected to be signed in 2017 Indicative timeframe for procurement: Expected to be launched in 2017 Indicative budget for procurement: € 3,000,000 Legal basis: Article 57 of Regulation 726/2004 as amended by Regulation (EU) No 1235/2010 Budget line: B3105 Activity statement: Effectiveness and pharmacoepidemiology studies Objective: See Work programme 2017, heading 1.5 Budget: € 10,500,000 Financial year: 2017-2021 Description of action: Research on utilisation, effectiveness and safety of medicinal products post-authorisation to generate data and information supporting regulatory decision-making, including research on the effectiveness of regulatory measures taken and on the impact of relevant legislation Type of contract: Service framework contract with re-opening of competition Number of contracts: 5 Indicative timeframe for contract: Expected to be signed in 2018 Indicative timeframe for procurement: Expected to be launched in 2017 Indicative budget for procurement: € 10,500,000 Legal basis: Article 57 of Regulation 726/2004 as amended by Regulation (EU) No 1235/2010 and Article 31 of Directive 2001/83 Budget line: B3030 Activity statement: Effectiveness and pharmacoepidemiology studies Objective: See Work programme 2017, heading 1.5 Budget: € 1,500,000 Financial year: 2017 Description of action: Research on utilisation, effectiveness and safety of medicinal products post-authorisation to generate data and information supporting regulatory decision-making, including research on the effectiveness of regulatory measures taken and on the impact of relevant legislation Type of contract: Re-opening of competition from existing framework contracts Number of contracts: Estimated 6 Indicative timeframe for contract: Expected to be signed in 2017 (approx. 12-18 months each) Indicative timeframe for procurement: Expected to be launched in 2017 Indicative budget for procurement: € 1,500,000 Legal basis: Article 57 of Regulation 726/2004 as amended by Regulation (EU) No 1235/2010 and Article 31 of Directive 2001/83 Budget line: B3030 Work programme 2017 EMA/583016/2016 Page 117/123