Public procurement notice: Contract Notice
Published: 2016-01-12
Buyer: Medicines and Healthcare products Regulatory Agency
Country: UK
Region: LONDON
Contract type: Services
Procedure: Open procedure
CPV classification: 72212300: Document creation software programming services | 72212325 | 72413000: Website design services | 79822500
Estimated value: 1 EUR
Submission deadline: 2016-02-02
Award criteria: The most economic tender

Technical requirements: This questionnaire has been issued by the Medicines and Healthcare Products Regulatory Agency, also referred to as ‘the Agency’) on behalf of the Competent Authorities for Medical Devices (CAMD) project. The CAMD network is an umbrella under which the national competent authorities in the EU, and associated parties to the system (European Free Trade Association (EFTA) and Turkey), work to enhance the level of collaborative work in what is a single market for medical devices.
Competent authorities have specific responsibilities for market surveillance and other activity under the terms of the legislation. The governance for the network was changed in 2014 to incorporate an elected executive. The executive was charged with developing better collaboration with the European Commission to improve both strategic planning and the distribution of work across both Commission-led and CAMD-led working groups.
The Dalli plan set out 3 challenges: enhance collaborative working; improve market surveillance; and better communication. Subsequently, the CAMD network has initiated 2 Joint Action projects which are designed to help the member states deliver on these commitments, and develop better mechanisms for working together and sharing workload:
— Incorporates the information and communication requirements of the CAMD and current and future Joint Action projects to stakeholders;
— Has strong linkage to the EU Commission website to enhance stakeholder's ability to navigate the regulatory landscape and locate appropriate organisations and information;
— Is an asset to stakeholders in all participating member states, enhancing engagement and transparency.
— CAMD partners (key people who are working on the Joint Action project via 1 or more of its major groups);
— Devices regulatory staff working in Competent Authorities (CA) across all EU member states and the European Economic Area (EEA);
Content will be developed and provided to the supplier by the CAMD project team at appropriate points in the project development. See Ideal / indicative project timetable.
The website will be in English but we would want to consider including a free ware translate function or design so that can be effectively translated by Google, etc.
The supplier will build the site in open source, using an easy-to-use CMS. We are assuming there would be no licence fee if written in open source. Once the website is built the CAMD project team will take over content management. A number of project managers will need access from various member states to upload and update information.
The supplier will provide reasonable training and ongoing support in the use of the CMS for the duration of the project (to 31.12.2019).
The supplier will maintain the site and make reasonable updates during the project lifespan (to autumn 2019) through an agreed number of ad hoc development days included in the contract. Significant additional changes within the lifespan will be subject to separate negotiation and agreement.
The website should be in place and in use before the end of April 2016 (Beta version) with a finished site ready no later than July 2016.
The website and its content needs to meet industry standards for accessibility for example Level AA of the Web Content Accessibility Guidelines (WCAG) 2.0.

Eligibility requirements: Under the Public Contracts Regulations 2015 Regulation 57 (1), potential suppliers will be excluded the procurement process if there is evidence of convictions relating to: — Conspiracy within the meaning of section 1 or 1A of the Criminal Law Act 1977 (a) or article 9 or 9A of the Criminal Attempts and Conspiracy (Northern Ireland) Order 1983 (b) where that conspiracy relates to participation in a criminal organisation as defined in Article 2 of Council Framework Decision 2008/841/JHA on the fight against organised crime (c); — Corruption within the meaning of section 1 (2) of the Public Bodies Corrupt Practices Act 1889 (d) or section 1 of the Prevention of Corruption Act 1906 (e); — The common law offence of bribery; — ‘Bribery within the meaning of sections 1, 2 or 6 of the Bribery Act 2010 (f), or section 113 of the Representation of the People Act 1983 (g);’ — ‘Where the offence relates to fraud affecting the European Communities’ financial interests as defined by Article 1 of the Convention on the protection of the financial interests of the European Communities (h): (i) The common law offence of cheating the Revenue; (ii) The common law offence of conspiracy to defraud; (iii) Fraud or theft within the meaning of the Theft Act 1968 (i), the Theft Act (Northern Ireland) 1969 (j), the Theft Act 1978 (k) or the Theft (Northern Ireland) Order 1978 (l); (iv) Fraudulent trading within the meaning of section 458 of the Companies Act 1985 (m), article 451 of the Companies (Northern Ireland) Order 1986 (n) or section 993 of the Companies Act 2006 (o); (v) Fraudulent evasion within the meaning of section 170 of the Customs and Excise Management Act 1979 (p) or section 72 of the Value Added Tax Act 1994 (q); (vi) An offence in connection with taxation in the European Union within the meaning of section 71 of the Criminal Justice Act 1993 (r); (vii) Destroying, defacing or concealing of documents or procuring the execution of a valuable security within the meaning of section 20 of the Theft Act 1968 (s) or section 19 of the Theft Act (Northern Ireland) 1969 (t); (viii) Fraud within the meaning of section 2, 3 or 4 of the Fraud Act 2006 (u); or (ix) The possession of articles for use in frauds within the meaning of section 6 of the Fraud Act 2006, or the making, adapting, supplying or offering to supply articles for use in frauds within the meaning of section 7 of that Act;’ — ‘Any offence listed — (i) In section 41 of the Counter Terrorism Act 2008 (a); or (ii) In Schedule 2 to that Act where the court has determined that there is a terrorist connection;’ — Any offence under sections 44 to 46 of the Serious Crime Act 2007 (b) which relates to an offence covered by subparagraph (f); Money laundering within the meaning of sections 340 (11) and 415 of the Proceeds of Crime Act 2002 (c); An offence in connection with the proceeds of criminal conduct within the meaning of section 93A, 93B or 93C of the Criminal Justice Act 1988 (d) or article 45, 46 or 47 of the Proceeds of Crime (Northern Ireland) Order 1996 (e); — An offence under section 4 of the Asylum and Immigration (Treatment of Claimants, etc.) Act 2004 (f); — An offence under section 59A of the Sexual Offences Act 2003 (g); — An offence under section 71 of the Coroners and Justice Act 2009 (h); — An offence in connection with the proceeds of drug trafficking within the meaning of section 49, 50 or 51 of the Drug Trafficking Act 1994 (i); or — ‘Any other offence within the meaning of Article 57 (1) of the Public Contracts Directive — (i) As defined by the law of any jurisdiction outside England and Wales and Northern Ireland; or (ii) Created, after the day on which these Regulations were made, in the law of England and Wales or Northern Ireland.’ — ‘Under the Public Contracts Regulations 2015 regulations 57 (3) an economic operator shall be excluded from participation in a procurement procedure where the following circumstances apply. (a) Economic operator is in breach of its obligations relating to the payment of taxes or social security contributions; and (b) The breach has been established by a judicial or administrative decision having final and binding effect in accordance with the legal provisions of the country in which it is established or with those of any of the jurisdictions of the United Kingdom. Exceptions may be considered if the economic operator has fulfilled its obligations by paying, or entering into a binding arrangement with a view to paying, the taxes or social security contributions due, including, where applicable, any interest accrued or fines. Use this question to explain any answers of yes above. The Authority is will exclude you from consideration if any of the following apply without good reason or explanation. Where the economic operator is bankrupt or is the subject of insolvency or winding up proceedings, where its assets are being administered by a liquidator or by the Court, where it is in an arrangement with creditors, where its business activities are suspended or it is in any analogous situation arising from a similar procedure under the laws and regulations of any State; The economic operator is guilty of grave professional misconduct, which renders its integrity questionable; The economic operator has entered into agreements with other economic operators aimed at distorting competition; ‘Where a conflict of interest within the meaning of regulation 24 cannot be effectively remedied by other, less intrusive, measures; Regulation 24: 24 — (1) Contracting authorities shall take appropriate measures to effectively prevent, identify and remedy conflicts of interest arising in the conduct of procurement procedures so as to avoid any distortion of competition and to ensure equal treatment of all economic operators. (2) For the purposes of paragraph (1), the concept of conflicts of interest shall at least cover any situation where relevant staff members have, directly or indirectly, a financial, economic or other personal interest which might be perceived to compromise their impartiality and independence in the context of the procurement procedure. (3) In paragraph (2)— ‘Relevant Staff Members’ means staff members of the contracting authority, or of a procurement service provider acting on behalf of the contracting authority, who are involved in the conduct of the procurement procedure or may influence the outcome of that procedure; and ‘Procurement Service Provider’ means a public or private body which offers ancillary purchasing activities on the market.’ ‘Where a distortion of competition from the prior involvement of the economic operator in the preparation of the procurement procedure, as referred to in regulation 41, cannot be remedied by other, less intrusive, measures; Regulation 41: (1) Where a candidate or tenderer, or an undertaking related to a candidate or tenderer; (a) Has advised the contracting authority, whether in the context of regulation 40 or not, or (b) Has otherwise been involved in the preparation of the procurement procedure, the contracting authority shall take appropriate measures to ensure that competition is not distorted by the participation of that candidate or tenderer.’ ‘Where the economic operator has shown significant or persistent deficiencies in the performance of a substantive requirement under a prior public contract, a prior contract with a contracting entity, or a prior concession contract, which led to early termination of that prior contract, damages or other comparable sanctions; ‘Where the economic operator — (i) Has been guilty of serious misrepresentation in supplying the information required for the verification of the absence of grounds for exclusion or the fulfilment of the selection criteria; or (ii) Has withheld such information or is not able to submit supporting documents required under regulation 59; or’ ‘Where the economic operator has — (i) Undertaken to — (aa) Unduly influence the decision-making process of the contracting authority; or (bb) Obtain confidential information that may confer upon it undue advantages in the procurement procedure; or (ii) Negligently provided misleading information that may have a material influence on decisions concerning exclusion, selection or award.’ The agency reserves the right to use its discretion to exclude a supplier where it can demonstrate the supplier’s non-payment of taxes/social security contributions where no binding legal decision has been taken. This section only applies where the agency has indicated that the contract is over 5 000 000 GBP in value. ‘Occasion of Tax Non-Compliance’ means: (a) — Any tax return of the Supplier submitted to a Relevant Tax Authority on or after 1.10.2012 is found to be incorrect as a result of: (a) 1 — A Relevant Tax Authority successfully challenging the Supplier under the General Anti-Abuse Rule or the Halifax Abuse Principle or under any tax rules or legislation that have an effect equivalent or similar to the General Anti-Abuse Rule or the Halifax Abuse Principle; (a) 2 — The failure of an avoidance scheme which the Supplier was involved in, and which was, or should have been, notified to a Relevant Tax Authority under the DOTAS or any equivalent or similar regime; and/or (b) The Supplier’s tax affairs give rise on or after 1.4.2013 to a criminal conviction in any jurisdiction for tax related offences which is not spent at the Effective Date or to a penalty for civil fraud or evasion. Under regulation 58 of the Public Contracts Regulation 2015 the agency will undertake an assessment of your organisation's economic and financial standing. You will be contacted by the agency if this assessment identifies that a parent or other type of guarantee is required. You will need to provide 1 of the following set out below (Regulation 60 (6) Public Contracts Regulations 2015: i) A copy of your audited accounts for the 2 most recent years; ii) A statement of your turnover, profit and loss account and cash flow for the most recent year of trading; iii) A statement of your cash flow forecast for the current year and a bank letter outlining the current cash and credit position; iv) Alternative means of demonstrating financial status if trading for less than a year. The agency may assess the past performance of a Supplier (through a Certificate of Performance provided by a Customer or other means of evidence). The authority may take into account any failure to discharge obligations under the previous principal relevant contracts of the Supplier. The agency may also assess whether specified minimum standards for reliability for such contracts are met. In addition, the agency may re-assess reliability based on past performance at key stages in the procurement process (i.e. supplier selection, tender evaluation, contract award stage etc.). Suppliers may also be asked to update the evidence they provide in this section to reflect more recent performance on new or existing contracts (or to confirm that nothing has changed).
Under regulation 58 of the Public Contracts Regulation 2015 the agency will undertake an assessment of your organisation's economic and financial standing. You will be contacted by the agency if this assessment identifies that a parent or other type of guarantee is required. You will need to provide 1 of the following set out below (Regulation 60 (6) Public Contracts Regulations 2015: i) A copy of your audited accounts for the 2 most recent years; ii) A statement of your turnover, profit and loss account and cash flow for the most recent year of trading; iii) A statement of your cash flow forecast for the current year and a bank letter outlining the current cash and credit position; iv) Alternative means of demonstrating financial status if trading for less than a year.
The agency may assess the past performance of a Supplier (through a Certificate of Performance provided by a Customer or other means of evidence). The authority may take into account any failure to discharge obligations under the previous principal relevant contracts of the Supplier. The agency may also assess whether specified minimum standards for reliability for such contracts are met. In addition, the agency may re-assess reliability based on past performance at key stages in the procurement process (i.e. supplier selection, tender evaluation, contract award stage etc.). Suppliers may also be asked to update the evidence they provide in this section to reflect more recent performance on new or existing contracts (or to confirm that nothing has changed).

Award value: 1