Public procurement notice: Contract Notice
Published: 2016-04-27
Buyer: Medicines and Healthcare products Regulatory Agency
Country: UK
Region: UNITED KINGDOM
Contract type: Services
Procedure: Open procedure
CPV classification: 22110000 | 79800000 | 79824000
Estimated value: 4500000 GBP
Submission deadline: 2016-06-17
Award criteria: The most economic tender

Technical requirements: The Medicines and Healthcare products Regulatory Agency publishes the British Pharmacopoeia. The British Pharmacopoeia (BP) is the official collection of standards for UK medicinal products and pharmaceutical substances. Produced by the British Pharmacopoeia Commission Secretariat of the Medicines and Healthcare products Regulatory Agency, the BP makes an important contribution to public health by setting publicly available standards for the quality of medicines.
Since 1864, the BP has been providing authoritative standards for medicinal products and pharmaceutical substances and it continues to play an important role in the standard-setting process worldwide. Now used in over 100 countries, the BP remains an essential reference for all individuals and organisations working within pharmaceutical research and development, manufacture and testing around the globe. The British Pharmacopoeia is published in both hard and electronic formats.
The agency has a requirement for a supplier to revise, publish, market and sell the British Pharmacopoeia on behalf of the agency.
The Medicines and Healthcare products Regulatory Agency is a Government Trading Fund and an Executive Agency of the Department of Health established on 1.4.2003. We have around 1 270 staff, with a total budget of approximately 150 000 000 GBP. We protect and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. There are three segments to the agency's work:
Regulates medicines and medical devices, ensuring that they work, and are acceptably safe; focusing on the core activities of product licensing, inspection and enforcement, and pharmacovigilance.
Gives access to an unparalleled resource for conducting observational research and improving the efficiency of interventional research, across all areas of health, medicines and devices.
World leaders in assuring the quality of biological medicines through product testing, developing standards and reference materials and carrying out applied research.
Participants will be advised if this is necessary during the procurement. Parent company and/or other guarantees of performance and financial liability may be required by the agency if considered appropriate.
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);
— ‘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):—
(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);

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 October 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). For this requirement the successful supplier must have ISO9001 or an equivalent qualification. The successful supplier will need experience in managing a large volume of texts through sign off and generation of multiple formats for an annually produced publication. Please provide examples of your qualifications in this respect. The successful supplier must have proven experience and capabilities with content management systems. Please provide examples of your qualifications in this respect. The successful supplier must have capability and experience with digital publication and in digital platform provision and webshops. What is your experience in providing web based digital platforms that are accessed worldwide by varying user bases (single user to global network licences) and product types? The successful supplier must have proven capability and experience with hardcopy printing/manufacture. Please provide examples of your qualifications in this respect. The successful supplier must have proven capability and experience with global logistics/distribution, sales and marketing. Please provide examples of your qualifications in this respect.
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). For this requirement the successful supplier must have ISO9001 or an equivalent qualification. The successful supplier will need experience in managing a large volume of texts through sign off and generation of multiple formats for an annually produced publication. Please provide examples of your qualifications in this respect. The successful supplier must have proven experience and capabilities with content management systems. Please provide examples of your qualifications in this respect. The successful supplier must have capability and experience with digital publication and in digital platform provision and webshops. What is your experience in providing web based digital platforms that are accessed worldwide by varying user bases (single user to global network licences) and product types? The successful supplier must have proven capability and experience with hardcopy printing/manufacture. Please provide examples of your qualifications in this respect. The successful supplier must have proven capability and experience with global logistics/distribution, sales and marketing. Please provide examples of your qualifications in this respect.
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).
For this requirement the successful supplier must have ISO9001 or an equivalent qualification. The successful supplier will need experience in managing a large volume of texts through sign off and generation of multiple formats for an annually produced publication. Please provide examples of your qualifications in this respect. The successful supplier must have proven experience and capabilities with content management systems. Please provide examples of your qualifications in this respect. The successful supplier must have capability and experience with digital publication and in digital platform provision and webshops. What is your experience in providing web based digital platforms that are accessed worldwide by varying user bases (single user to global network licences) and product types? The successful supplier must have proven capability and experience with hardcopy printing/manufacture. Please provide examples of your qualifications in this respect. The successful supplier must have proven capability and experience with global logistics/distribution, sales and marketing. Please provide examples of your qualifications in this respect.