Commercial Medicines Unit (CMU) The OJEU procurement process and the Bravo etendering system Alex Williams Category Specialist – Branded medicines South and West nww.cmu.nhs.uk

EU Procurement Procurement The regulations Identifying and understanding a demand for goods, services, works Strategy for meeting this requirement via a contract Evaluation of information received by the purchasing organisation to identify competent suppliers Ensuring the demand is being fulfilled as expected The regulations Legal framework for procurement All organisations tasked with spending public funds are covered formalise the approach to and process of procurement, reducing the opportunity for fraudulent activity and improve competition across the EU Created in 1970, current version is EU directive 2004/18/EC Written into UK law in 2006 For goods & Services the threshold for enactment is £113,057

EU Procurement A summary of the regulations are available on the Cabinet Office website Benefits By following organisations ensure they are being: Open and transparent – allowing tenderers to understand what you are going to do and how you are going to do it Be objective and ensure equal treatment of tenderers – allow all tenderers a fair and equal chance of winning the contract Be consistent – do what you said you were going to do competition between suppliers of all sizes, by ensuring that opportunities are advertised clearly and openly across the EU Suppliers are given complete information on the purchasing authority’s requirements, and how that authority is to establish who the preferred bidder is Auditability

EU procurement A robust procurement process that ensures Fairness, transparency and equality. It affords a level playing field to all. Pharmaceuticals: any consortia or CMU-hosted projects will deliver benefits to the NHS and suppliers from aggregated demand, and support for once-only principles which lowers administrative costs for all parties. In practice Procurement timescales set by the regulations Dependant on type of procurement process being run, but are based on the priciple of fair time available for suppliers to review and reply Example of CMU contracting processes for Pharma Restricted Open

Procurement processes Restricted procedure – More complex tenders Used where it is necessary to shortlist interested parties before invitation to tender is issued Advertising, required where the threshold is reached: OJEU adverts created and published Available from http://ted.europa.eu/TED, search companies and the Bravo eTendering system Advert details Who the procuring authority is A description of the type of goods / services Where the contract is to operate The estimated funds to be spent The conditions of responding to the advert, for example any criteria that the interested supplier must comply with, to be considered for the invitation to offer stage The time limits for responding to the advert Duration of the contract And sometimes, the awarding criteria will be provided as well

Procurement processes CPV codes Identification of products or services being sought Details of the codes can be found here 33690000 – Primary for pharmaceuticals, many sub codes available All CMU adverts include appropriate codes Adverts / tender opportunities can be found by searching for the CPV codes Pre qualification (PQQ) Registering interest – via Bravo, available for 37 days typically Eligibility to tender, criteria for responding and participation E.g. Technical, Competency, Financial Evaluation of information – shortlisting companies to be invited to tender SID4Health – central database of standard company information Reducing the need to supply for each tender

Procurement processes Invitation to tender (ITT) Under restricted, only supplier passing the stated criteria will be invited Main area of work for suppliers 40 days availability, complaint offers must be returned in this time Tender document pack Specification: what’s needed and how it is to be delivered, Terms and conditions: how the contract is to operate and function throughout it’s lifetime; Offer schedule: what the suppliers are being asked to offer for, plus any supporting market information or clarification that will enable the organisation to construct the most beneficial bid. Award criteria: details exactly how the bid is to be assessed. Under the EU regs, awarding criteria will fall in to two types: Firstly, lowest price wins. Secondly, the most economically advantageous offer, which is a balance of factors, such as quality, security of supply, price, delivery. The latter is typically the only one used by CMU.

Procurement processes Open procedure No PQQ stage Used where no shortlisting of interested companies is needed Typical for most contracts CMU work on Immediate access to tender documents and the offer schedule openly available Decision on it’s use is a balance of sensitivities, risk, benefit and opportunity Reduction in timescales, no 37 day PQQ process, only 52 day ITT Timescales can be lengthened if needed or shortened to a degree if certain criteria are met and it does not disadvantage suppliers. Negotiation following return of offers – not permitted under Open or Restricted procedures Other procedures – more complex contracting requirements Negotiated, competitive dialogue

The final stage The procurement process, final stages Awarding a contract Opening and reviewing offers Assessment in line with stated award / evaluation criteria to identify the winning supplier or suppliers who meet the requirements Notification of awards Successful and unsuccessful suppliers notified of the contracting authorities decision Successful suppliers informed of the awarded items and detail behind the decisions Unsuccessful suppliers provided with transparent information on the awarding decision, detailing why the outcomes were reached Alcatel / Mandatory Standstill Period (MSP) All awards reserved for 10 days to allow any supplier to challenge if they believe they have been treated unfairly Following the MSP, if no objections have been raised, the authority is able to confirm all awards and enter into contract with suppliers

eProcurement eTendering / eProcurement systems. Web based, Bravo is used by CMU Most eTendering systems broadly similar, communication portal Secure, registered user only access No barriers to suppliers Process set up to follow EU directives and timescales Online storage of tender and offer documents with messaging systems Fully auditable, on both sides Email alerts to prompt for required actions to be performed or to confirm completion of tender stages by suppliers Contract opportunities (OJEU adverts), list is available on the site’s homepage PQQ’s and ITT set up within specific project folders Reduction in paper trail and process time

Bravo run through www.cmu.bravosolution.nhs.uk Registration Finding opportunities Responding to a PQQ Accessing an ITT Messaging functions Responding to an ITT / submitting a bid Example

To finish Training Specific training events possible if demand is there CMU instructional documentation within ITT document packs One 2 one assistance and walk throughs Bravo training documents hosted on Bravo website Contact – If needed, please let me know and I can put you in touch with: Specialised pharmaceuticals team, likely to be the most appropriate CMU team for NHS manufacturing unit enquiries Sourcing specialists, assistance with the tender process and Bravo Alex.williams@cmu.nhs.uk Questions