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Laboratory Technology Group

L@B-BRIEF NOVEMBER 2016

Contents Headlines ............................................................ 1 Introduction .......................................................... 2 Economic News ................................................... 2 UK News & Events ............................................... 3 Export News & Events.......................................... 7 Healthcare ......................................................... 15 Health & Safety .................................................. 15 Contact GAMBICA ............................................. 18

Headlines ■ Introduction

Diary Events ■ Economic News

Autumn Statement

Trade

Janney Montgomery Scott report that Bioproduction is storming ahead and Trump good for NIH funding

■ GAMBICA UK News & Events

S-lab Awards and conference May 9th & 10

th 2017

Amazon, CBBC, EEF, Hack Science, Innovate UK, Innovation DB Forum and Hallam Associates all at the 2017 Annual Laboratory Technology Suppliers Conference

More scams

NPL Instruments launched to help accelerate industrial innovation in the UK

Analysis for Innovators - £6.5m funding

Business rates increase in 2017

MHRA list of laboratories approved to carry out chemical tests

Lab Innovations keep most happy and expands to new hall for 2017

Another successful WWEM in Telford

UK Events ■ Export News & Events

Issues with Turkish Customs – your feedback required

MEDLAB Europe – September 2017 – Barcelona

Export group meeting – 14th December 2016 – Dealing with difficult

countries

Analytica China 2016 - once again a super show

BCEIA – October 2017

ACHEMA, FRANKFURT, 11/15 JUNE 2018

MEDLAB 2017

PwC launches China Economic quarterly

Sales to Iran – UK banks take tentative steps into the market again

The HM Treasury consolidated list of targets

CETA finally signed by EU and Canada after weeks of uncertainty

TTIP talks move very slowly forward on technical issues

Conflicts minerals – last touches before the approval of the regulation

EC Communication on Trade Defence Instruments European view for Brexit negotiations

Department for International Trade (DIT) launches public beta of the new GREAT.gov.uk platform

IP protection overseas

Medica 2016 Report

ECO Notices ■ Healthcare

NICE to charge companies for work and MHRA to change charging structure

Wessex AHSN’s 3rd

Annual Health Innovation Programme ■ HR & Personnel

Changes to the Immigration Rules- update for employers

The changes that are likely to take place in April 2017

Other Autumn 2016 changes to be aware of

Immigration Acts 2016

New drafts for REACH guidance updates available ■ Contact GAMBICA

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NOVEMBER issue of L@B-BRIEF

Introduction Welcome to the November Lab-Brief and due to exhibitions, meetings and other events I can’t remember a busier one. Lab Innovations was once again a good show for most and Medica was definitely better than last year, although with the changes for 2017-2019 it could be interesting for the next few years. We have reports inside from all the shows including WWEM. Philip Hammonds’ Autumn Statement revealed little but we have a summary inside, together with links to the full statement (if you are an insomniac). The Export group meeting on December 14th is a full house and places at the annual conference are filling fast too. Details on the annual conference are inside and include the addition (definitely I am assured) of a speaker from Amazon. Also inside are articles on the autumn statement, the latest round of scams, reports from this months shows, Lab Innovations, WWEM and Medica, Sales to Iran, DIT’s new GREAT website, consultations from NICE and MHRA plus much more. We look forward to seeing some of you at the annual lunch and hope you all have a great run up to the end of the year. We will be back with a slightly reduced December Lab-Brief next month Best regards Tim Collins Director – Laboratory Technology Group Economic News Autumn Statement The policy paper on the Autumn Statement can be found here The Productivity section (4) is quite relevant, particularly 4.10 R&D and 4.11 Trade R&D The 4 year spend on R&D is £4.7b, which is below housing but above transport. To put into perspective, the forecast additional £2b in 2020/21 equates to about 0.1% of GDP, so it isn’t really making much impact on the call from CBI to move from 1.6% to 3% Table 3.1: National Productivity Investment Fund (£m)

2017-18

2018-19

2019-20

2020-21 TOTAL

Housing 1465 2060 2490 2145 8160

Accelerated construction 285 635 665 380 1965

Affordable housing (2) 1,120 1,125 880 340 3465

Housing Infrastructure Fund 60 300 945 1,425 2730

Transport 475 790 705 1050 3020

Roads and local transport 365 500 430 650 1945

Next generation vehicles 75 100 110 115 400

Digital railways enhancements 30 55 165 285 535 Cambridge-Milton Keynes-Oxford corridor 5 135 0 0 140 Digital Communications - Fibre and 5G 25 150 275 290 740

Research and Development 425 820 1500 2000 4745

Totals 2,390 3,820 4,970 5,485 16665

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Trade The Trade section talks about increasing appetite, support and currencies – 4.11 Trade UK Export Finance (UKEF) – The government will provide additional support through UKEF to ensure that no viable UK export should fail for lack of finance or insurance from the private sector, by:

Doubling its total risk appetite to £5 billion, and increasing capacity for support in individual markets by up to 100%; this will be supported by an improved risk management framework and the use of private insurance markets to reduce Exchequer exposure

Increasing the number of pre-approved local currencies in which UKEF can offer support from 10 to 40, enabling more overseas buyers of UK exports to pay in their own currency

Supporting trade policy and exiting the EU – Additional resource will be provided to strengthen trade policy capability in the Department for International Trade (DIT) and Foreign and Commonwealth Office, totalling £26 million a year by 2019-20. There will also be additional resource of up to £51 million in 2016-17 for the Department for Exiting the European Union to support the re-negotiation of the UK’s relationship with the European Union. Up to £94 million a year of additional resource will be allocated from 2017-18 until the UK’s exit is complete. In total this will mean up to £412 million of additional funding over the course of this Parliament. The devil will be in the details but it would appear little, if any, extra will go in to financial support for exporting companies. There is a full summary of the autumn statement in the download centre. Janney Montgomery Scott report that Bioproduction is storming ahead and Trump good for NIH funding The bioproduction market looks buoyant due to increasing number of biosimilars in phase I to III (it is believed to be around 350 at this point) stage for FDA approval. Companies who supply in to these areas look set to benefit They additionally feel that the new Trump administration will be better for NIH funding – their note below was sent out just before the US election results Trump or Hillary will be a better backdrop for National Institute of Health (NIH) funding than eight years of the Obama Administration. The President's priorities within the $880 billion Health & Human Services (HHS) budget has been those providing immediate impact, like aid for the poor. Between the House, Senate, and White House, Obama has been the least conservative for annual NIH funding with his preference for inflation based upticks (2-3%). The FY16 +6.6% National Institute of Health (NIH) budget increase that was approved in December 2015 was the result of House Republicans and Senate compromise not a proactive Obama Administration. The NIH, distributing 80% of its $32 billion to universities, has historically had a 2-3% budget increase, but we see dramatic change coming from a Clinton or Trump win. UK News & Events S-lab Awards and Conference May 9th & 10th 2017 After a series of successful one-day conferences in 2016, S-lab in conjunction with UKSPA together with content partners; Praxis UNICO, Innovation DB, IASP and York Science park are to hold a two day conference with exhibition and awards dinner at York Racecourse on May 9th & 10th. In addition we also plan to hold a one-day BLMA management training course.

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Opportunities for sponsorship and exhibiting are available shortly. If you would like to register your interest please visit the download centre or visit the S-lab website at http://www.effectivelab.org.uk Amazon, CBBC, EEF, Hack Science, Innovate UK, Innovation DB Forum and Hallam Associates all at the 2017 Annual Laboratory technology suppliers’ conference. The 2017 Lab suppliers’ conference will see fifty plus MD’s, Country heads, CEOs and directors from across the industry, meet for an excellent networking dinner and stimulating conference on January 16th & 17th 2017 at Fawsley Hall, nr Daventry. Subjects covered will include an economic update, innovation and rapid development, how to access companies on science parks, social media, brexit, China, finance plus more. So join your colleagues from Anton Paar, to VWR and Camlab to Thermo Fisher Scientific on January 16th & 17th Book by November 30th to claim the early bird rate. Full details and the booking form are on the Gambica website and in the download centre or email sonia.dougall@gambica.org.uk

More scams It seems to be scam season with several doing the rounds We recommend everyone remains cautious in their on-line activities, especially as everyone seems very busy and some of these can easily be overlooked when signing off. Below are three examples A Gambica member has seen dangerous phishing emails using their old titles and logos (and they cannot do anything about these).

GAMBICA has seen an Eastern EU company claiming they can get your trade mark approved for a few grand – but in fact it’s just a scam) The third is in the email below, sent in by one of our members (thanks to them) and follows closely from the Bath Uni one we reported earlier. Be vigilant and check it out first - ask us too if you think its suspect but not sure as sometimes they are genuine too.

From: Admin [mailto:purchasing@procurement-birhamedu.org] Sent: 28 October 2016

09:07 To: Info (a gambica member) Subject: Inquiry

Attention: Sales

The University of Birmingham is requiring setting up a corporate trading account with your company and we hereby submit a quote request for products below;

Kindly confirm your stock/vendor availability on below items.

Removed here but it was for kit the company made and a reasonable but not outrageous request We would provide an official credit reference sheet for Net 30 application process, this will enable us to submit a purchase order upon approval or you can send us your credit application form. Looking forward to hearing from you.

-- Best Regards.Geoff WilliamsUniversity of BirminghamCompany Registration number: RC000645VAT registration number: GB 729 8561 87Edgbaston, BirminghamWest Midlands B15 2TTPhone: +441214680230Fax : +441214680244

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These are the UK ones, many others come from overseas, an example below Dear Sir/Madam, We are authorized government/Business agent based in Ministry of Endowment and Islamic Affairs,the Islamic State of Qatar. There is an ongoing offer for the supply of your products to the government of Islamic State of Qatar under the Ministry of Endowment and Islamic Affairs project procurement division for the ongoing promotional and rehabilitation projects in the country. I am an agent and my interest for every business I do is my commission and as a commission agent,i am assuring you that i will try my possible best to ensure the offer is secured on behalf of your company in order to crate room for my commission. Please can you furnish me in full details about the standard of your products either by email attachment or your website for presentation to the buyers. Best Regard, Thanks, Mr Abudu Musa PO Box:200212, 5/F Off #34,Al Kuwari Bldg, Opp Royal Plaza,Al Sadd, Qatar. taota@himeji.sanyo-steel.co.jp (email address looks close but it’s fake and nothing to do with sanyo! – so don’t use it)

NPL Instruments launched to help accelerate industrial innovation in the UK NPL has announced the launch of NPL Instruments bringing its world-class measurement instruments and expertise still closer to industry, improving quality, productivity and efficiency. NASA, MOD, Defra and ESA are already benefitting from new service. Analysis for Innovators - £6.5M funding

New funding programme - analysis for inovators (A4I) - offering cutting edge R&D, expertise and facilities to UK companies that want to solve an analysis or measurement problem. Series of Roadshow events, including one at NPL on 06 December 2016 – click on the link above for more information. Business Rates increase in 2017 The next business rates revaluation will come into effect on 1st April 2017. Your new assessment will be based on the rental value of properties in England & Wales as at 1st April 2015. Some are already seeing big gaps in the way properties are being assessed, and increases of up to 210%, which simply cannot be explained in rental terms. Companies are currently paying business rates on valuations set at the top end of the market as of 1st April 2008, which still do not reflect the drop in rental values of up to 15% as a result of the effects of recession on the commercial rental market. In effect this means businesses are already paying in excess of their rental values. Richard Ellis at Addison James explains the problem. "Quite simply, we are currently undertaking appeals on rateable values, successfully securing reductions and adjustments to take into account the drop in rental values. In many cases, businesses are reducing their liabilities to the tune of thousands of pounds. It therefore goes against the market, to see the kind of increases that the South are going to be facing in less than a year from now." The VOA are rolling out sweeping increases, hard hitting industry in areas that have been affected by a market downturn, and low productivity.

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London is seeing the harshest increases for almost a decade. Richard explains, "You cannot take thousands of companies out of the rating system by exempting them from business rates and raising the exemption threshold for businesses with rateable values of less than £15,000; or absorb reductions in the North of England, without someone having to pay for that loss in revenue. The Treasury still need £28bn a year out of business rates, and those left picking up the cost are sadly going to be those companies who fare best in what has become a lottery postcode". Companies may wish to get an independent valuation if they disagree with the rates they are sent or get one prior to the re-evaluation. MHRA list of laboratories approved to carry out chemical tests

Any test facility which conducts, or intends to conduct, regulatory studies must comply with good laboratory practice (GLP) regulations when carrying out safety tests on:

pharmaceuticals

agrochemicals

veterinary medicines

industrial chemicals

cosmetics

additives for human food and animal feed

biocides The test facility must belong to the UK GLP compliance monitoring programme, run by the UK GLP Monitoring Authority (UK GLPMA). The programme is only open to facilities in the UK. Test facilities that are contracted to work on part of a larger regulatory study should also usually be members of the compliance programme. Exceptions There may be exceptional circumstances when a part of a regulatory study may need to be contracted out to a test facility that is not a member of the compliance programme. In this case, the study director must make sure that GLPMA guidance is followed. For a list of approved labs click here Lab Innovations keeps most happy and expands to new hall for 2017 Taking place on 2nd and 3rd of November in the pavilion at the NEC Lab Innovations was deemed by most to be a good show. 25 Gambica members (up from 22 in 2015) were amongst approximately 120 exhibitors, filling the pavilion space, including the upper floor attached to one side. Feedback from the 18 members I managed to get round and ask on the afternoon of the second day was generally very positive and gave an average score of just over 7 (last year was 7.1) with two 9’s, two 4’s (obviously didn’t work for them) and the rest were 7’s and 8’s with one 6. The show has grown in exhibitors and floor space and has had enough visitors grow to make it work too. We don’t have any official numbers yet but sources suggest around 2400 visitors over the two days, with the second day possibly a little busier but there was not much in it. The good news is the types of visitors, who continue to be of high quality. The visitor badge scanning system seemed to work well too. Next year Lab Innovations 2017 will be on November 1 & 2 and will be relocating to Hall 12, which is slightly larger and all on one level. The organisers tell us over 70% of exhibitors from this year have already booked for 2017. For more information contact Mauricio Montes – email Mauricio.montes@easyfairs.com Another successful WWEM in Telford My colleagues Andrew Evans and Sebastian Amos were at WWEM in Telford on 2nd and 3rd November. They report it was a pretty good turnout, both in terms of visitors and exhibitors. The conference dinner was once again an enjoyable event, even if the chips weren’t real! The next WWEM will again be at the Telford International convention centre on 21st and 22nd November 2018

Please visit the download centre for full details on UK Events.

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Export News & Events Issues with Turkish Customs – your feedback required We have had several reports from members regarding Turkish customs who are being extremely pedantic with concerns such as the clarity of the CE mark or the text on an invoice/paperwork that doesn’t exactly align or match with the text on the product etc. Whilst possibly correct technically, this is causing significant delays in getting products into the country and upsetting customers. Sometime there has been complete rejection with products refused entry and being returned. We would like to hear from any members who have had similar issues, so we can put this forward to the appropriate government departments – please email (in confidence) Tim Collins. MEDLAB Europe – September 2017 – Barcelona The Medlab (was part of Arabhealth this year) organisers are looking at looking at launching a new Medlab Europe show in Barcelona next September. Would this be of interest to members who usually exhibit at either Medica or Medlab? We would be interested in any feedback form members. Please email Tim Collins Export group meeting – 14th December 2016 – Dealing with difficult countries The draft Agenda and booking form are in the download centre – this one will be at Suez London offices in High Holborn. Places are limited to a total of 22 places, so please book early to avoid disappointment. BCEIA – October 2017 Although booking forms for the UK group are not yet available, we have a block booked at BCEIA in Beijing 2017. The show runs from 9-11 October 2017 at the China National Convention Centre (at the Olympic Park). We already have a number of companies reserving space after Analytica China and if you wish to reserve a slot, please let Kirsty Roberts know. ACHEMA, FRANKFURT, 11/15 JUNE 2018 As usual GAMBICA will be co-ordinating a British group presence in the Laboratory Technology sector in Hall 4.2. As you participated at the event in 2015, you should have received DECHEMA’s Application Documents by now, but please contact me if you have not received them yet. Please note their closing date for priority applications is 15 November 2016. If you would like to participate within the GAMBICA group please see below regarding the application procedure. APPLICATION PROCEDURE As in the past, group participants are required to submit their application document direct to Dechema. The contact at Dechema is Sabine Picard, email address picard@dechema.de. We suggest that companies wishing to join the GAMBICA group complete Section 7 on the form with something along the lines of 'GAMBICA Group Area – Hall 4.2'. It would also be useful, but not essential, if you wouldn’t mind copying me with your application form. To download the application forms and information please visit www.achema.de. The forms can be completed online. Alternatively, please contact myself for a pdf version. If you would like to discuss possible participation within the GAMBICA group please also contact Kirsty Roberts (kirsty.roberts@gambica.org.uk) GROUP LOCATION We have requested that the group area be moved slightly closer to the entrance of hall 4.2 (to try to move away from the emergency staircase walls). We will advise as soon as we have confirmation of the GAMBICA group location.

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DIT TAP SUPPORT It is too early for confirmation of TAP support for ACHEMA 2018 although we are confident that the event will receive TAP funding at a rate of £1,500 per company. We expect confirmation of support in late 2017, and will advise as and when. MANAGEMENT FEES Again it is too early for us to accurately predict the level of management fee. They will, we think, increase over 2015 (Member rate £670, Non Member £845), but we will try to keep any increase to a minimum (exchange rates permitting!!). We will confirm the management fees nearer the time. STAND CONSTRUCTION

As in the past, a number of British group participants arrange their own stand construction within the group. In addition, GAMBICA will once again offer a lower cost, good quality, shell scheme package option and we will be in touch nearer the time with details of this. Again, for budget purposes, we expect this to be in the region of £150/£160 per square metre. If you have any questions regarding participation with the GAMBICA group please do not hesitate to contact Kirsty Roberts. MEDLAB 2017 – 6-9 Feb 2017 – Exhibit or £350.00 (plus travel & accommodation). Two 3sqm pods available with support from DIT and several bonuses Gambica has been organising a UK group to Medlab for many years now. The show, originally part of Arabhealth, had grown so large (along with the conference that is held alongside) that the organisers have pulled the show out of Arabhealth and decided to run it a week later. A risk but with 10,000 delegates at the conference it has a good chance of succeeding. The group is located in a great place at the end of one of the crossover points to the other Zabeel halls (where the other half of the show is) and en route to the delegate’s refreshment area. We have two 3sqm pod stands available for £2500, plus a management fee of £350. UKTI grants available worth £2500 for eligible companies. For more details email Kirsty Roberts or visit the Gambica website bookings must be made by 21st December 2016. Since 28 July 2016, Notices to Exporters have been published on GOV.UK. Indian company visiting the UK in December and looking for Analytical and Biotechnology products to represent in India The note below has come from one of our friends at the UK consulate in Bengaluru (so it’s worth considering and not some random enquiry. Deeksha is a leader in the Analytical and Bio-technological market. At Deeksha they market the state-of-the-art equipment that power the analytical scientists of today. (www.deekshainstruments.com ).They are travelling to the UK from 9th to 19th December 2016 and looking for collaboration with UK companies who would be manufacturing Laboratory Instruments for Biotechnology/Biology/Pharmaceutical manufacturing. If you are interested in meeting with them, please contact ganeshad@vsnl.net PwC launches China Economic Quarterly In the latest issue by PwC, you can find topical commentaries on China's Communist Party General Secretary Xi Jinping's latest speech on the role of the Party in the management of state-owned enterprises (SOEs), China's supply-side structural reforms and pilot programme on SOE reform. To find out more about the market outlook and its implications for businesses in China, please click http://www.pwccn.com/home/eng/china_economic_quarterly_nov2016.html Sales to Iran – UK banks take tentative steps in to the market again, HM treasury advice and updates from DIT We have seen an increasing number of members asking about dealing with Iran again. The Iranians are keen to buy from UK suppliers and DIT has had a commercial officer in post for 6

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months but even once you have clearance from the ECO (if needed), one of the main stumbling blocks has been how to get your money back in to the UK. We also asked HM treasury if you also still need to report sales to Iran? HM treasury response is below, further on is a statement from Natwest on dealing with Iran Thank you for your email. Please note that HM Treasury is unable to provide legal advice and it is your responsibility to familiarise yourself with the relevant sanctions legislation, although you may find the following of assistance when considering sanctions under EU law. The Treasury is prepared to assist with queries relating to the EU Regulations but it does so on the basis that its views are not determinative of questions of law and, if in any doubt, you should seek independent legal advice in relation to the matters you raise which may be complex and may require analysis of the specific detail of any proposed transactions. We are able to comment only in general terms and with reference to the limited details you have provided. On authorisation and notification You may be aware that Implementation Day occurred on Saturday 16 January 2016. This was the day on which Iran completed its nuclear-related commitments under the Joint Comprehensive Plan of Action (JCPOA) and received extensive sanctions relief. As a part of this sanctions relief, the prohibitions upon financial transfers to and from Iran (including the requirements for prior notification and authorisation) were lifted. Consequently, transfers of funds between EU persons, entities or bodies, including EU financial and credit institutions, and non-listed Iranian persons, entities or bodies, are permitted as of Implementation Day. The requirement to seek prior authorisation for, or notify HM Treasury of, transfers of funds sent to or received from Iran, is therefore no longer applicable. On banking channels The Government fully supports expanding our trade relationship with Iran, in accordance with remaining sanctions. However, banks will be considering a range of factors when deciding whether to provide banking facilities for UK-Iran business, including remaining sanctions, corruption and money laundering risks. It is for banks to decide on their own risk appetite and to take into account the costs of managing those risks. It is not the place of the Government to influence the commercial decisions of banks, nor to force banks to offer financial services to specific customers. HM Treasury is liaising with UK-based banking industry bodies, such as the British Bankers’ Association (BBA) and the Association of Foreign Banks (AFB), and with UK-based banks, to understand their concerns and to work with them to find a financial channel solution for Iranian payments. You will wish to investigate which banks are willing to facilitate the payment of funds to/from Iran to the UK. This could be done by exploring the range of Prudential Regulation Authority (PRA) authorised and Financial Conduct Authority (FCA) regulated banks available in the UK. On remaining sanctions You should also be aware that some sanctions remain in place and it is your responsibility to ensure you are compliant with all sanctions regimes. If you are dealing with Iran related financial transactions you will need to ensure that you are not looking to deal, either directly or indirectly, with a designated entity either in the supply of material to Iran or in the payment route utilised. Even after Implementation Day a number of Iranian entities are still designated e.g. for proliferation, human rights and terrorism concerns. Making funds and economic resources to these entities, directly or indirectly, is still prohibited in the absence of a licence. If you are looking to deal with an entity designated under financial sanctions you will need to approach HM Treasury with information about your proposed dealings and the relevant grounds for licensing, who will consider whether a licence can be issued. For further guidance please see the HMT Financial Sanctions pages and the HM Treasury Consolidated List of sanctioned entities at the links below. The HM Treasury Consolidated List of Targets can be found at this link: https://www.gov.uk/government/publications/financial-sanctions-consolidated-list-of-targets/consolidated-list-of-targets

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Further information about Iranian sanctions can be found at this link: https://www.gov.uk/guidance/sanctions-on-iran Nat West Policy Please find below our current policies regarding trading with Iran, this includes transfers between a subsidiary or entity linked with Iran. In regards to Iran I can advise that whilst NatWest Sanction Policy and appetite has not changed and we absolutely require every customer to pre-advise of every inbound or outbound payment, well before it occurs, that is directly or indirectly linked to Iran (or any other sanctioned individual, entity or jurisdiction). Please note you should not commit to any deal until prior approval is given. This will ensure payments do not arrive or get blocked by filters. Current policy is to simply return such payments. However, we will now consider, on a case-by-case basis, requests for payment transactions and customer relationships that fall within our risk appetite and do not involve a US person or element. Please do not commit to any activity, as each proposal will require individual and specific sanctions and reputational risk approval in advance of it being actually processed. Please note, your request may or may be approved, this decision is derived by the Sanction advisory team and the Reputational Risk Committee. There is extensive investigation that needs to occur therefore any requests can take up to 12 weeks for a decision to be made, however we cannot commit to a definitive timeline. Below are the details that will be required prior to any monies being received: Do you require any licences for this activity? If so we will need a copy, if not can you please clarify the reasons why you believe that they are bot needed. Details of all parties involved in a transaction, directly or indirectly, (including banks, importers/exporters, shipping companies, vessels, insurance companies etc.) Is the activity facilitated through a third party? If so please provide full details of all parties. What percentage of your business is carried out in any of the sanctioned jurisdictions? How do you expect the business within Iran to materially change in the next 3 years? Details of all countries involved (such as ports of lading/discharge, transhipment) Detail purpose of transaction, including the underlying goods /services where relevant Details of any US persons involved (directly or Indirectly) in the trade Currency and value of the transaction Copies of all relevant trade documentation Details of all due diligence that has been undertaken to date We need to carry out enhanced due diligence (EDD) on the Iranian party you want to deal with. Please provide: · Details of all directors and Ultimate beneficial owners (UBO’s) of the Iranian entities involved, including all end users of the goods / services. · Details of evidence that they have obtained to rule out any influence/ownership/control by the sanctions designated Iranian Revolutionary Guard Corps (IRGC) over their Iranian customer. · A clear and verifiable statement that no person, product or components involved with the transaction has any US connection. · A detailed statement confirming how they believe their goods or services involved are not impacted by any Dual Use goods regulations. (What advice have they taken on this matter - evidence should be obtained and submitted with the transaction request)? · What due diligence have you undertaken to satisfy that you Iranian party you propose to transact with does not fall or relate to any International sanctions as applicable under UK Law? Other areas to note are: · We will not consider approvals for any payments which are due or expected any further ahead than the next 30 days given the possibility that either regulations or risk appetite may

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change at short notice and please note a payment request that undergoes this process does not guarantee approval, we have had many cases that have declined. The decision is based on a number of factors and the decision power lies with the two committees. · Any approval given will be strictly on the basis that the actual payment message will need to have a reference to Iran included on it. As such you will need to work with your Iran counterparty to find a suitable payment route as not all banks will support Iranian transactions regardless of whether RBS has approved of the payment. Each bank will act inline with there own policy and risk appetites. · In the future there maybe a fee for these approvals which we will advise when this applies. (possibly £10,000 per transaction request) · Finally, please consider how commercially viable it is for you to pursue the Iranian business? · In order to set the expectation there is a significant amount of work and governance required which will take a considerable amount of time and patience as we need to be fully comfortable from a sanction and risk appetite perspective before a decision is given for Iranian related requests. The more information we can gather will help us to make a decision one whether we are comfortable to receive this payment.” General terms on dealing with Iran from DIT were updated earlier in the month and can be found at https://www.gov.uk/government/publications/doing-business-with-iran/frequently-asked-questions-on-doing-business-with-iran THE EXPORT GROUP MEETING WILL HAVE THE MIDDLE EAST ASSOCIATIONS CEO, PETER MEYER, AS IT’S GUEST SPEAKER ON DECEMBER 14TH CETA finally signed by EU and Canada after weeks of uncertainty The Comprehensive Economic and Trade Agreement (CETA) between the European Union and Canada was finally signed after intensive debates at regional, national and European level. During weeks it seemed that no agreement could be found, as not all 28 EU member states were ready to support CETA, notably the Belgium regional Wallonia. CETA was scheduled to be signed by Canada and the EU on 27 October in Brussels during the EU-Canada summit, which had to be postponed. Negotiations between the EU and Canada started back in 2009. In mid-2014, the conclusion of the EU-Canada negotiators was announced. Following the replacement of the Investor-state dispute settlement (ISDS) arbitration system with the Investment Court System (ICS) at the request of the EU, the legal review of the texted was completed in February 2016. Orgalime welcomes CETA since it eliminates tariffs for engineering products, simplifies customs procedures and opens up public procurement both at federal and regional level in Canada. Many experts feared that if CETA was not signed, it would have been a big set-back to the European Union’s credibility at international level in trade matters as foreign partners could have been reluctant to engage in long negotiation if they were not sure that, once a deal is agreed upon, it will into force. The next step in the process is the consent of the European Parliament after which most parts of the CETA agreement can be provisionally applied. Provisional application will however not concern investment dispute rules. Since CETA has been deemed a mixed agreement, covering both EU and non-EU areas of competence, Member States will also have to ratify it for the areas which fall under their responsibility, notably Investment Court System. TTIP talks move very slowly forward on technical issues The 15th round of TTIP negotiation took place in New York during the first week of October 2016. The European Commission is aiming at finalising the Technical Barriers to Trade chapter (Regulatory Cooperation) before the end of 2016. On conformity assessment, the European Commission is looking at ways to allow US bodies to certify according to European

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Union legislation without having to be in the European Union while European conformity assessment bodies would not need to be in the US to certify according to the US legislation. The US is moving forward on accreditation by creating some sort of accreditation system. Little progress was reported on standardisation as the US is refusing to refer to International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) standards. The European Commission is carefully considering the next steps on the engineering annex due to the resistance on it from the US side. The July 2016 EU proposal is still on the table. The next round of negotiations will take place during the first week of December 2016 in Brussels. The future of the negotiations will largely depend on the result of the US elections, to be held on November 8, with both presidential candidates not being overly supportive of foreign trade. As it is expected that it will take around six months to have the new US negotiating team in place, negotiations are foreseen to slow down in the first semester of 2017. Conflict minerals – last touches before the approval of the Regulation On 15 June, a political understanding between the European Commission, the European Parliament and the Council was found on conflict minerals. This agreement entails mandatory reporting for smelters and refiners (upstream industries) of tin, tantalum and tungsten (3Ts) and gold as well as for most importers. Around 95% of the volume of imports is set to be covered by the mandatory scheme (the exact amount of the threshold is still under discussion). Downstream industries are exempted from mandatory reporting, which is what Orgalime has been advocating for. The European Commission will develop guidelines and tools, including Key Performance Indicators, in order to encourage voluntary reporting for downstream companies that employ more than 500 people according to the non-financial reporting Directive. The Regulation will also recognise already existing industry schemes that are aligned with the OECD guidelines. Some issues are still under discussion, such as the transitional period, which could be 3 years, and the review clause. Orgalime position is that the timeline for the review should allow enough time to assess the real impact of the new legislation on the ground. The next political trialogue meeting, where all outstanding issues could be ironed out, will take place at the end November 2016 in Strasbourg. The Regulation is scheduled to enter into force in mid-2017. Orgalime had the opportunity to meet with the Italian permanent representation and with the assistant of Member of the European Parliament Mr Winkler, the rapporteur on this dossier, conveying our position against mandatory reporting for downstream industries. EC Communication on Trade Defense Instruments On 18 October, the European Commission has put forward a Communication aimed at ensuring a robust trade policy in the European Union. In the document, the European Commission is calling upon the European Council to approve its 2013 proposal to modernised trade defence instrument. In particular, the Commission is proposing to do away with the so-called “lesser duty rule”. According to the lesser duty rule, once both the dumping from the third country and the injury for the EU industry is established, the level of the anti-dumping is imposed either at the level of the duping margin or at the level that removes the injury, whichever is lower. Deleting this rule would lead to considerably higher anti-dumping duties. On November 9, the European Commission will also propose a new anti-dumping methodology to take into account market distortions due to state interventions in third countries. The new methodology will be country-neutral, meaning that it will apply not only to China but to all foreign countries. The EU industry will still be the only party that can file a complaint to start an anti-dumping investigation. In order to support the EU industry, the European Commission will draft specific reports for country or sector where distortion will be identified; this reports could be used by the EU industry to substantiate their case. This new methodology could be used only in investigations started after the legislative changes enter into force.

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European views for Brexit negotiations The first phase of COBCOEs Brexit Ambition project is bottom-up research across the European business community. This is an opportunity for your company to influence Brexit negotiations. The simple survey has been created in eight languages. To take part please use this link: http://www.cobcoe.eu/brexit-2/cobcoe-survey/ Department for International Trade (DIT) launches public beta of the new GREAT.gov.uk platform. The new digital platform brings together all commercial and International aspects of Government support for exporting, investment, tourism and education with signposts to other sources of help and advice. The site aims to:

Inspire UK businesses to export, and overseas companies to invest in the UK;

provide more tailored support and advice online;

put businesses in touch with each other so they can build personal networks; and

connect UK supply with global demand Areas covered include:

E-market place tools

Find a buyer service and find a supplier (for international visitors)

Single destination for export information

Improved export services

Gov.uk improvements

Country guides IP protection overseas – article from open to export

There are a lot of considerations to take into account when starting to branch out and trade overseas. One major problem that we warn clients about is the potential for their great designs and trade marks and technology to be imitated and used without permission in overseas countries. This is why it is important to register your trade marks, patents and designs abroad. How Do I Protect My Business Outside the UK? In our piece on here titled ‘Putting Your Intellectual Property In Order At Home‘ we mention that you should first look to put your IP in order at home and begin by identifying the portfolio of IP assets that you have in existence etc. Once identified and registrations and safeguards have been put in place at home it is far easier to extend this protection into new global markets. To read the whole article please click here Medica 2016 Report – pretty good but the end of Halls 1 and 2!

2016 was the second time the show has run from Monday to Thursday, so it probably represents a better gauge of what to expect at the show against last year, when various circumstances and the day shifts probably didn’t give a true reflection. However just to throw a spanner in the works, this was the last time that the UK group will exhibit (along with everyone else) in the existing halls 1 and 2, as they will be demolished and a new Hall 1 (slightly larger than the existing one and two), will be built in there place. It will open in 2019. During this new build, all the exhibitors currently in 1 and 2 will be moved to prefabricated temporary halls L1, L2 and 18. L1 and L2 are located adjacent to Hall 3 (which is currently one of the lab tech and diagnostics halls along with 1 & 2) The Gambica/UK group will be located in hall L2, which will be at the back of Hall 3 and probably the best location of the three temporary halls. The temporary halls are not tents but are made of steel and glass at the sides and a decent roof (they say). We will be able to build up to 6m high and therefore will no have a problem displaying Union flags prominently.

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That all over how was the show? There were 33 companies (plus Gambica and BIVDA) in the UK group (out of 50 exhibiting UK companies in the clinical lab and diagnostics halls). Traffic seemed better than the year before but in total less than at its peak 5 or 6 or so years ago. That said it is still a busy show – but now spread over 4 days instead of two and a half. Day 1 was OK, day 2 probably the busiest, day 3 Ok and day 4 much quieter but not as quiet as a Saturday used to be). Indeed many packed up early and probably shouldn’t have. The average score from the companies, on the quick and dirty survey, was a whisker over 7.7. That was among the 27 companies I managed to bag before they disappeared! This compared to 7 last year so a significant improvement. We had one score 10, one 9.5 and two 9’s but also one score of 5 and three of 6 with the rest scoring 7 or 8. Generally most were satisfied with 85% of those asked saying the show met the expectations (or exceeded it) and 22 said they would be back with 4 saying probably and one possibly. These scores are much more in line with previous Medicas, except last year when only 62.5% said it met their expectations (84% in 2014) and 22% said no (4% in 2014), the rest (15.5% - 12% in 2014) saying not fully or not quite. Average number of enquiries per company was 83 (not that this means much as the make up of companies changes every year) but that was less that in 2015 when it was 90. There were a few orders promised or given at the show that totalled around £40K but longer term is only when we find out what really happened. All thought orders would follow later. Next year the show continues with the Monday to Thursday show days starting on 14th November and finishing on 17th. Forms for 2017 will hopefully be out later in January 2017. Email Kirsty if you are interested as we have, for the most part, sold out in every year if I have attended (10 plus years). ECO Notices The Export Control Organisation has updated and amended five Open General Export Licences (OGELs) following an update to the EU dual-use list, which was published in the EU Official Journal, 15 November 2016. The updates include changes to the goods schedule of each relevant licence. Ivory Coast and Liberia have been removed from the list of excluded destinations for the OGEL (PCBs and components for dual-use items). This follows the removal of EU sanctions in June 2016. All licences have been updated to refer to the new Department for International Trade, of which the Export Control Organisation now forms a part and to amend the address (where relevant) for the MOD team in the Export Control Joint Unit (who process Form 680 applications). Open General Export Licence (international non-proliferation regime decontrols: dual-use items) has been revoked as it is no longer of use to exporters. Licences affected • Open general export licence (export after exhibition: dual-use items) • Open general export licence (export after repair/replacement under warranty: dual-use

items) • Open general export licence (export for repair/replacement under warranty: dual-use items) • Open general export licence (PCBs and components for dual-use items) Open general export licence (oil and gas exploration: dual-use items) If you can no longer meet the terms and conditions of a particular licence because the scope of the goods or destinations have changed, or if a licence has been revoked, then you will need to de-register from the licence via SPIRE.

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If your goods are no longer subject to export controls because the relevant rating code has been amended or deleted then you no longer need a licence to export those goods. However, you will still need to complete an annual return at the end of the calendar year in December for any exports of these goods made under an Open General or Open Individual Export Licence. If your goods are still controlled but not listed under an appropriate OGEL, you will need to apply for a Standard Individual Export Licence. Read more about open general export licences (OGELs).

The Export Control Organisation (ECO) has published the latest edition of the Consolidated List of Strategic Military and Dual-use Items that Require Export Authorisation. See: Notices to Exporters 2016/25: ECO publishes latest version of consolidated list Read the European Commission's detailed summary of changes. Please visit the download centre for full details on Export Events. Healthcare NICE to charge companies for work and MHRA to change charging structure The long awaited recast of the Medical Device and In-Vitro Directives are due in the spring of 2017. There are significant changes likely that will mean increased regulatory requirements for manufactures and suppliers, including the need to report to notified bodies and increased conformity assessment. NICE put out a consultation earlier this year (august) saying it intends to charge for its technology appraisal (TA) and highly specialised technologies (HST) guidance, from the 2017/18 financial year, subject to the necessary approvals and amendments to NICE’s Governing Regulations. MHRA have launched one consultation and are due to launch another consultation. The first open consultation: Proposals on increases and additions to current medical devices fees was launched on 24th November and runs until January 13th 2017 – more at https://www.gov.uk/government/consultations/proposals-on-increases-and-additions-to-current-medical-devices-fees The second is on charging for their services based on your TO in the UK market. The proposal is to levy a charge of around 0.1% of the company sales. It is hoped this consultation will be out in late January 2017 and implemented in April 2018 Wessex AHSN’s 3rd annual Health Innovation Programme

In partnership with SETsquared we will be running our annual Health Innovation Programme (HIP) in Feb 2017, and the application process is now open. This 3 day course is aimed at innovators and entrepreneurs who are looking to start or expand a healthcare related business. In previous years, delegates from Universities, the NHS and established companies have found it extremely valuable. Visit the download center for the event flier. HR & Personnel Changes to the Immigration Rules – Update for Employers The important changes to the Immigration Rules which employers and sponsored workers need to be aware came into effect on 24 November 2016, They are as follows:- Tier2 (General) The minimum salary threshold for experienced workers has increased to £25,000. This will increase again in April 2017 to £30,000. The threshold remains £20,800 for new entrants i.e. those under the age of 26 or international students switching from Tier 4 to Tier 2.

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An exemption from this increase will apply for nurses, medical radiographers, paramedics and secondary school teachers (mathematics, physics, chemistry, computer science and Mandarin). The exemption will end in July 2019. Those employed under a graduate training programme will be able to change occupation within the programme or at the end of the programme, without their sponsor needing to carry out a further Resident Labour Market Test or the need for them to make a new application. Nurses will continue to remain on the Shortage Occupation List but employers will need to carry out a Resident Labour Market Test before proceeding to sponsor a nurse under the Tier 2 (General) visa. Tier2 (Intra-Company Transfer) The Skills Transfer sub-category has now been closed. The minimum salary threshold for the Short Term sub-category has increased from £24,800 to £30,000. The minimum salary threshold for the Graduate Trainees sub-category has been reduced from £24,800 to £23,000 and the number of trainees each employer may sponsor has increased from 5 to 20. The changes that are likely to take place in April 2017 The exemption currently from having to pay the Immigration Health Surcharge to Tier 2 (ICT) Migrants and their dependents is likely to be removed. The new Immigration Skills Charge will be introduced and will be set at £1,000 per year for a sponsored worker of a large businesses and £364 per year for SMEs and charities. Exemptions will be applied to PhD occupations, ICT Graduate Trainees sub-category and international students switching from Tier 4 to Tier 2 (General). Other Autumn 2016 changes to be aware of The Home Office have previously accepted applications submitted within 28 days of a persons immigration status expiring regardless of the reason for the overstay. This has now been reduced to 14 days and an out of time application will only be granted if there is a good reason beyond the applicants control for the overstay. The Rules have been amended to enable a Tier 5 A-Rated sponsor to certify maintenance in respect of a Tier 5 migrant and their dependents. Immigration Act 2016 Two important provisions were introduced on 12 July 2016: A new offence of illegal working The offence is committed when a migrant works in the UK when he knows or has ‘reasonable cause to believe’ that he is disqualified from working. The offence carries a maximum term of imprisonment of up to 51 weeks or a fine, or both. A confiscation order may also be made under the Proceeds of Crime Act 2002 to cease the earnings of the convicted illegal worker An amended illegal employment offence for employers The offence has been widened to not only include employers who ‘knowingly’ employ illegal workers but also employers who have ‘reasonable cause to believe’ that the employee is disqualified from employment by reason of their immigration status. The maximum term of imprisonment has increased from 2 to 5 years. Immigration officers have also been given the power to arrest without warrant any person who they have reasonable grounds of suspecting has committed or is attempting to commit the offence of employing a person illegally. It should also be noted that on 1 December 2016 immigration officers will be given additional powers under The Act to close business premises for up to 48 hours if employers who have committed immigration offences and they will be able to apply to the court for a compliance order to impose special measures, including ongoing closure, on the employer to prevent illegal working. Why you should be concerned? The bar has been reduced from ‘knowingly’ employing someone who does not have the permission to do so if as an employer you could be found to have had ‘reasonable cause to believe’ that the employee did not have or had ceased to have the right to work in the UK.

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It should also be noted that if an employee of the business who has responsibility on behalf the business of any aspect of the employment of an individual has reasonable cause or believe that the employee does not have the right to work then the business will be treated as having ‘reasonable cause to believe ’that fact. The 2016 Act does not give a definition of ‘reasonable cause to believe’ and it will therefore appear that the law will be developed on a case by case basis. The threshold will certainly be higher than mere negligence as this is the function of the civil penalty regime though, the bar has been set lower than ‘knowingly’ employing someone who does not have the correct immigration status. Those employers who hold a Tier 2 license who fall foul of this legislation are likely to have their license revoked and the immigration permission of all migrant employees sponsored under the license curtailed. The business is likely to be prevented from applying for another Tier 2 license for a period of up to 12 months. What you should be doing? It is recommended that you review your right to work checks to ensure that your system and procedures are robust in order for you to maintain the statutory excuse for all employees. You should also review your procedures in relation to change of circumstances and new information received after the employment has commenced. HR and line managers should be given training on the new changes and what circumstances may trigger having ‘reasonable cause to believe’ and the action to be taken. Our thanks to paragon law for this update – for more information email thalejv@paragonlaw.co.uk

STANDARDS & REGULATIONS The download centre contains a copy of the latest Low Voltage Directive (LVD) 2016 guidelines.

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CONTACT GAMBICA

The GAMBICA Association Limited Westminster Tower 3 Albert Embankment London SE1 7SL

Tel: +44 (0)20 7642 8080 Email: info@gambica.org.uk Website: www.gambica.org.uk

GAMBICA Laboratory Technology Group

Laboratory sector issues Laboratory-related

regulations Export Group Service Managers Group NHS Issues Healthcare Group Management Committee

Tim Collins 020 7642 8091

tim.collins@gambica.org.uk

Newsletter Editor Press Releases General enquiries &

administrative support to the Laboratory Sector

Sonia Dougall

020 7642 8093

sonia.dougall@gambica.org.uk

International trade fairs and events

Kirsty Roberts

020 7642 8086

kirsty.roberts@gambica.org.uk

General regulatory issues, Technical standards and Directive

Process sector issues Process, Measurement,

Control & Systems Group (PMCSG)

Flammable Atmospheres Group (FLAG)

Controlgear Group Technical Committee (CGTC)

LVD, MD, EMCD, ATEX & PED

European Accreditation Market Surveillance

Andrew Evans

020 7642 8083

andrew.evans@gambica.org.uk

Environmental Issues WEEE, RoHS and EUP

ISO 9000/14000 issues

Anne Humberstone

020 7793 3011

anne.humberstone@gambica.org.uk

Overseas distributors database

BSI Standards Committee Membership

General GAMBICA enquiries

Sarah Wicks 020 7642 8080

sarah.wicks@gambica.org.uk

TOLLS Service Statistics

Helena Robinson

020 642 8088

helena.robinson@gambica.org.uk

Chief Executive – GAMBICA Graeme Philp

020 7642 8085

graeme.philp@gambica.org.uk

Membership applications

General Publications

Website updates

020 7642 8080

General enquiries 020 7642 8080

info@gambica.org.uk