The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. The online application makes it possible to request a cGMP Declaration (Current Good Manufacturing Practice). A cGMP Declaration can be issued by the FDA to a foreign regulator, such as the competent authorities of an EU Member State. The declaration issued by the FDA is intended to confirm the current cGMP US compliance status for the requesting establishment.
On September 24, 2018 and September 28, 2018, the Department of Veterans Affairs (VA) and the Small Business Administration (SBA), respectively, released complementary final rules (VA final rule and SBA final rule) that amend the regulations governing Veteran-Owned Small Businesses (VOSBs) and Service-Disabled Veteran-Owned Small Businesses (SDVOSBs). Effective October 1, 2018, the SBA’s regulations now govern the ownership and control requirements for all VOSBs and SDVOSBs, and the VA regulations that formerly provided eligibility requirements for VOSBs and SDVOSBs have been eliminated. Continue Reading
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be amended in the event of a “no deal” scenario, i.e. if the UK leaves the EU on 29 March 2019 without the framework for a future EU-UK trading relationship agreed or a transition period.
The MHRA reiterates in the consultation that the UK government is committed to reaching agreement on a deal, but that it needs to prepare for all possible outcomes, including a “no deal” scenario.
In the event of a “no deal” scenario, the MHRA would become a standalone medicines and medical devices regulator. This means that the MHRA would take decisions and carry out functions for the UK market that are currently taken or carried out at an EU level, such as by the European Medicines Agency (EMA). For example, this would include decisions on all marketing authorisations, orphan designations and paediatric investigation plans, and all pharmacovigilance functions in the UK.
The consultation covers three Statutory Instruments (SIs) which would amend (i) the Human Medicines Regulations 2012 (HMRs) and the Medicines (Products for Human Use) (Fees) Regulations 2016, (ii) the Medicines for Human Use (Clinical Trials) Regulations 2004, and (iii) the Medical Devices Regulations 2002.
The changes are centred on three principles: patients should not be disadvantaged, innovators should be able to get products to the UK market as quickly and simply as possible, and the UK should continue to play a leading role promoting public health.
The proposed changes set out in the SIs reflect the policy positions in the UK government’s “no deal” technical notices covering medicines and devices, and provide additional detail as to the implementation mechanics. For example, the proposed amendments include a new schedule to the HMRs setting out the legal basis for converting an EU marketing authorisation into a UK national marketing authorisation immediately on the UK exiting the EU. This step would be in addition to any transfer of a central marketing authorisation from a UK marketing authorisation holder to a holder in one of the 27 EU Member States.
The purpose of the consultation is to give industry and other stakeholders an opportunity to scrutinise the proposed amendments before they become law. The consultation closes on 1 November 2018.
Deputy Secretary of Defense Patrick Shanahan announced on Monday, October 1, 2018, that the U.S. Department of Defense (“Department” or “DoD”) was withdrawing its proposal that would have made sweeping changes to the rules that govern the release of progress payments to contractors under DoD contracts. In rescinding the proposed rule, Deputy Secretary Shanahan cited to a lack of coordination within the Department that led to a premature release of the proposed amendments.
Under its proposed rule, DoD would have amended policy relating to progress payments and performance-based payments for DoD contractors by reducing the customary progress payment rate for large contractors from 80 percent to 50 percent of incurred costs. Increased payments—up to 95 percent of incurred costs—would have been tied to measures such as work quality and on-time delivery. A finding of fraud or criminal offense involving the contractor, even if related to a different project, would have reduced the rate to 25 percent of incurred costs. Small business contractors would have continued to receive a base rate of 90 percent of incurred costs under the proposed rule.
According to the Department, these changes were intended to align with the preference for use of performance-based payments expressed by Congress in Section 831 of the 2017 National Defense Authorization Act. DoD claimed such revisions were needed to “reset” progress payment rates to better align with lower interest rates, and avoid furthering what it described as the “unintended consequence of the past practice associated with providing contract financing in excess of what was necessary.”
Many lawmakers and the majority of the defense industry disagreed, raising concern that the rule misconstrued the preference for use of performance-based payments expressed in Section 831. They also worried that contractors would be unable to receive the increased payment rates conditioned on performance, as the criteria for receiving such rates were subjective and not adequately tied to actual contractor performance. Ultimately, the rule as proposed would have made it more difficult for businesses to do work with the DoD, and according to the proposal’s opponents, led to a stifling of defense contractor investment in innovation.
Rescission of the proposed rule offers at least a temporary win for defense contractors, who typically rely on progress payments to maintain necessary cash flow up and down the defense supply chain, including the cash flow needed to maintain innovative research and development activity. And while an updated set of proposed changes to the progress payment rules seem likely in the future, pressing pause on revisions offers contractors an opportunity to take an active role in helping to frame the Department’s policy on progress payments. Deputy Secretary Shanahan left the door open for continued discussion, providing lawmakers and industry the opportunity to engage in efforts to improve the progress payment system and reduce administrative burden on both contractors and the Department, alike. To better meet the preferences set in Section 831, the stakeholders involved will need to focus on payments that meaningfully align with contractor achievement and performance outcomes, in a way that is objective and provides a measure of predictability and reliability to contractors. Developing a rule that would achieve these goals would best serve both the Department and the contractors on which the Department relies, as well as the public’s interest in maintaining the United States’ national security in an increasingly challenging environment.
 Although the rule was rescinded before formal comments were due, a number of industry groups, including the Professional Services Council (PSC), the Aerospace Industries Association, and the National Defense Industrial Association, opposed the proposed rule in writing and during a DoD Public Meeting held on September 14, 2018.
In the final batch of technical notices, the UK Government has provided guidance on what impact traders can expect on food labelling and packaging in the event that the UK exits the EU without a Withdrawal Agreement on 29 March 2019.
Currently, EU rules, such as EU Regulation 1169/2011 or “FIC”, govern food labelling and minimum compositional standards (with some exceptions) for foods in the UK.
As explained in a previous blog, from 29 March 2019, these EU-based rules will be absorbed into English law as part of the Withdrawal Act and adapted where necessary by way of statutory instruments to ensure they apply as intended. There will however be a number of additional changes required to food labels to reflect the fact that the UK will no longer be a member of the EU:
(a) Origin labelling: For food and ingredients from the UK, the use of the term “EU” in origin labelling will no longer be correct and the term “UK” will need to be used instead.
The UK Government will also consider whether to implement rules on mandatory indications of country of origin or place of provenance on food labels to mirror the EU requirement to this effect that will apply from April 2020.
(b) Addresses on labels: For pre-packed products sold in the EU, the label currently needs to include the name and address in the EU of the responsible food business operator. Following 29 March 2019, labelling of pre-packed products sold in the UK and the EU will need to include both a UK address and an EU address to be valid in both markets. UK producers may need to set up a hub in another EU member state or work with an EU importer to be able to provide an EU address.
In order to mitigate the immediate effect of this change, the UK Government will allow for pre-packed products bearing an EU address and already placed on the UK market to be sold through until stocks run out. It is also considering whether products bearing an EU address should be allowed to be placed on the market for a period of up to 6 months following a no-deal Brexit.
(c) Natural Mineral Waters (NMWs): Currently, NMWs must undergo a specific recognition process based on EU rules in order to be marketed across the EU. Following a no-deal Brexit, the Government intends to amend domestic regulations to ensure that NMW recognitions granted in the EU will continue to be effective across the UK. However, NMWs recognised in the UK may no longer be accepted in the EU and NMW producers may have to make an application for recognition in the EU through one of the remaining member states. Such applications will be treated as ‘third country’ applications.
Currently, food and drink producers in the EU can protect the name of their products under the geographic indication (GI) regime, which protects GIs from imitation throughout the EU. At the moment, there are 86 GI-protected UK product names relating to food and drink products (including Cornish Pasty, Jersey Royal Potatoes and Cumberland Sausage) that together make up around 25% of the value of UK food and drink exports.
Following the UK’s exit from the EU, the UK will set up its own GI scheme, including a UK GI logo, that will mirror the EU regime and is intended to be no more burdensome for producers. Existing UK GIs will be given new UK GI status automatically. Further guidance will be published on the UK GI scheme in early 2019.
Current UK GIs may not continue to be protected under the EU GI regime after Brexit. UK producers wishing to retain their EU GI status and the right to use the EU GI logo will need to apply to the European Commission as a ‘third country’ applicant.
UK producers may also want to consider protecting their products by applying for EU Collective Marks or EU Certification Marks through the EU Intellectual Property Office or indirectly through the World International Property Organisation.
As expected, these notices indicate that a no-deal Brexit is likely to result in a number of practical issues for UK food and drink producers and greater obstacles to selling UK products in both the UK and the EU. The UK Government continues to stress its intention to reach a deal with the EU, but in the meantime, businesses must continue to prepare for a worst-case scenario.
The concept of human rights due diligence is at the heart of the UN Guiding Principles on Business and Human Rights (“UNGPs“) and is finding its way into a growing body of legislation around the world: see the French Duty of Vigilance Law, the supply chain transparency provisions of the UK Modern Slavery Act (and Australian counterpart), the California Supply Chain Transparency Act, the Dodd Frank Act, the EU Conflict Minerals Regulation and most recently in the draft UN treaty on business and human rights.
Under Principle 17 of the UNGPs, human rights due diligence should include assessing actual and potential human rights impacts, integrating and acting upon the findings, tracking responses, and communicating how impacts are addressed. It should also (i) cover human rights impacts that a business may cause or contribute to through its own activities, or which may be directly linked to its operations, products or services by its business relationships, and (ii) be on-going.
For many businesses, particularly those with global operations or supply chains involving a multitude of “business relationships”, conducting adequate human rights due diligence can be very challenging. Blockchain technology can help businesses to meet this challenge. In this blog we explore how.
What is blockchain?
Blockchain is a digital ledger that can be used to record transactions. It is decentralised, immutable and cryptographically secured. Information, once encrypted, cannot be modified. These qualities allow users of blockchain to share information or transact with one another without the use of an intermediary. Blockchain technology may originally have been synonymous with cryptocurrencies such as Bitcoin but its uses are wide-ranging and are being readily explored by users of new technology.
Because it is a shared rather than a copied database, everyone in the blockchain network can see and update its contents, providing potential benefits for supply chain management by increasing transparency. By using blockchain, it is possible for all participants in the supply chain to record information such as price, date, location, quality and certification, which can then be seen and monitored by other actors further down the chain. Any authorised participant can review entries, and users can amend or update information only if the network consensus algorithm validates it.
How can blockchain be used for due diligence?
The use of blockchain enables businesses to carry out more effective due diligence by helping them to identify potential adverse human rights impacts more quickly and cheaply.
How? Due diligence is only as good as the information it is based on. Blockchain offers the prospect of instantaneous and reliable recording of quality information throughout the life of a business’ supply chain, creating a transparent and immutably accurate trail of information that can then be easily audited.
A related development in the use of blockchain technology is the utilisation of the Internet of Things (“IoT“) in supply chains. IoT links the physical world to the digital world by collecting data from real-world objects/environments and turning that data into meaningful and useable information. For example, a product – whether extracted, farmed or created – can be allocated a unique cryptographic identifying code at its point of origin. This code is evidence (which can be saved to the blockchain) that at a point in time the product contained certain specific properties. Any subsequent mutations or additions to that product’s properties as it works its way through the supply chain can then be tracked, recorded and permanently saved on the blockchain. That product sourcing information could be shared with the ultimate consumer by simply scanning a code on the final product.
Beyond the theory: some practical examples
Several industries have already begun to develop the use of blockchain technology to improve their supply chain management. Facing significant pressure for increased traceability, the minerals extraction industry has been at the forefront of such initiatives.
Diamonds have long been the subject of controversy, notorious as they are for financing violence in conflict zones. Conflict diamonds, or so-called “blood diamonds” are defined by the United Nations as “diamonds that originate from areas controlled by forces or factions opposed to legitimate and internationally recognised governments, and are used to fund military action in opposition to those governments…” Under a UN resolution, the Kimberley Process – an international certification scheme for rough diamonds – was set up in 2003 to halt the trading of blood diamonds. Although the scheme has been implemented to great effect, there is no specific international law on the trading of blood diamonds and not all countries are signed up to the Kimberley Process. As a result, companies are developing other initiatives to ensure that buyers and retailers alike can track the path of their diamonds.
Everledger, a start-up which uses emerging technology to eliminate fraud and other corporate risks, has been using blockchain to track the provenance of diamonds since 2015. In January 2018, De Beers, the world’s biggest diamond producer, unveiled Tracr, an industry-wide blockchain to track each time a diamond changes hands. By using blockchain, an un-hackable, digital database, to track the journey of a diamond from the moment it is sourced, any conflict diamonds can be identified and inform the purchasing decisions of jewellers or consumers.
Cobalt made its way into the headlines when concerns were highlighted over the compliance of companies with international due diligence standards in the supply of cobalt for mobile phone and car batteries. More than half of the world’s supplies of cobalt come from the Democratic Republic of Congo (DRC) where, according to Amnesty, children as young as seven are mining cobalt. A pilot scheme is expected to launch later this year, under which each sealed bag of cobalt produced by a vetted artisanal mine will be given a digital tag, which is then entered on to a blockchain using a smartphone, along with details of the weight, date and time. Each time the bag is bought and sold the details will be entered on a blockchain, creating an incorruptible record of the cobalt’s journey from mine to smelter. The idea is that downstream buyers will be able to track exactly where their cobalt has originated and (providing the mines are monitored and vetted) ensure that it is not the product of child labour. This increased transparency will enable companies to avoid human rights abuses in their supply chains and expand their human rights investigative practices.
- Other industries
Other pioneers include the tuna fishing industry, where blockchain and IoT has been used to tag and track fish from “catch-to-customer” in order to combat and deter corruption, illegal trafficking and human slavery on tuna fishing boats. Additionally, Coca-Cola Co and the US State Department are launching a project using blockchain’s digital ledger technology to create a secure registry for workers that will help fight the use of forced labour worldwide, particularly in relation to sugarcane production. The registry serves to verify, in a secure way, the contracts of workers in large companies such as Coca-Cola. By improving the information available to companies, it is hoped blockchain will bring about a long-term change in working conditions.
Risks and Rewards
With blockchain, transactions and data are processed instantaneously and directly from peer to peer, removing the need for intermediaries. There is a low barrier to participation, as blockchain can be accessed via smartphone, which facilitates the collection of data. The information is stored digitally and on an open-source platform that is designed to be resilient (if not immune) to corruption – the validation process inhibiting the unilateral entry of false information. More direct interaction between participants in a supply chain may foster greater trust in the relationships, and in turn more opportunities for collaborative solutions to human rights issues that are so often structurally rooted.
In addition to promoting interaction between supply chain participants, blockchains are often, but do not have to be, publicly accessible. As consumers have increasing awareness and information about supply-chain issues, businesses can seek to gain a competitive advantage by increasing transparency and putting in place ethical and sustainable practices to manufacture and supply their products. In simple terms, blockchain technology can give consumers the ability to scan a unique code on an item, using their smartphone, and immediately have access to all information relating to that item, including its history and origins.
The use of blockchain for supply chain management is not without risk of course:
- The accuracy of the blockchain is only as good as the information recorded at each point of entry, which will in many cases still rely on human input – and with it human error (or manipulation). Despite the possibility of a so-called “51% attack”, where a group of blockchain users control the majority of the network’s computing power and effectively determine the blockchain’s accuracy, the multi-party validation process does significantly mitigate that risk as no one user can unilaterally enter false information.
- Finding the right balance between transparency and confidentiality may also be a challenge. Indeed, certain businesses will have legitimate concerns about disclosing strategically sensitive information about their supply chain. But some would argue the full potential of blockchain (both in terms of accuracy and legitimacy) is only being realised when the network is public and open – as opposed to remaining privately administrated by one entity. This is an area where industry-wide cooperation could enable progress to be made while maintaining a level-playing field.
It is still too early to herald blockchain as the cure to all due diligence headaches. For all the talk of its inviolability and resilience, the technology remains to be tested on a meaningful scale. However, it is exciting to see technology develop which helps businesses discharge their responsibility to respect human rights – the first, and perhaps most important, step of which is to identify adverse human rights impacts.
The UK Government has released a further batch of technical notices, providing guidance to businesses on the implications of an exit from the EU without a Withdrawal Agreement on 29 Mach 2019.
Three of these notices will be of particular interest to businesses trading goods in other EU Member States:
After Brexit, non-harmonised goods (goods which are regulated by national law rather than EU-wide rules) will cease to benefit from the mutual recognition principle, which allows the sale of goods across the EU if those goods have already been legally sold in another EU country.
This means that companies selling goods such as furniture, bicycles and textiles will have to ensure those goods comply with domestic regulations in each EU Member State where they are being sold. For many companies, this is likely to add complexity and delay to the manufacturing process, as well as introduce obstacles for companies who export or import goods to or from other EU countries.
Harmonised goods are currently regulated by EU-wide rules under the ‘New Approach’, which allows traders to certify compliance of their goods with international standards, for example by affixing a CE mark.UK bodies will be granted new approved status and will be able to continue to assess products for the UK market based on requirements that will be (at least initially) identical to current EU requirements. Traders will be able to continue using the existing conformity markings for a limited time after Brexit, but will then need to affix a new UK mark of approval.
In a no-deal scenario, goods that have already been placed on the market will be able to continue to circulate in the UK, but conformity assessments by UK bodies will no longer be recognised in the EU. This means that products previously tested by a UK notified body will need to be retested and re-marked by an EU-recognised body before being placed on the EU market.
Under current rules, manufacturers can appoint nominated persons to act as authorised representatives and carry out tasks such as holding technical documentation about their products and ensuring compliance with health and safety standards.
If the UK leaves the EU without a deal, UK-based nominated persons will no longer be recognised under EU law and businesses will need to nominate a new EU-authorised representative if they wish that representative to carry out tasks in the EU. Nominated persons in EU countries will continue to be recognised in the UK for a limited period (except for cosmetics), but will then need to be UK-based.
As these notices indicate, a no-deal Brexit is likely to result in a number of practical issues for UK traders placing goods on the EU market. While the Government has made it clear that it is confident that a deal will eventually be struck with the EU, it is imperative that businesses prepare for a no-deal outcome and continue to monitor these technical notices for additional guidance.
After the Court of Justice of the European Union (CJEU) had issued its landmark judgment in the Coty case1 on reference for preliminary ruling, the Higher Regional Court of Frankfurt (HRC Frankfurt) has issued its now published final ruling on 12 July 2018. As expected the HRC Frankfurt decided that the specific ban for online sales via non-authorised third-party platforms in the selective distribution system at issue does not violate Art. 101 TFEU.2 The judgment provides further practical guidance on the definition of the ‘luxury image’ of a product, as well as on the application of the so-called Metro criteria in cases of ‘incomplete selective distribution systems’.
In its recently published Annual Report 2017, the German Federal Cartel Office (FCO) welcomed the clarifications provided by the CJEU’s judgment, but made it clear that many questions in relation to platform bans for online sales still remain open. Continue Reading
In St. Louis Heart Center v. Nomax, Inc., the Eighth Circuit held that an “alleged failure to provide a technically compliant opt-out notice” in a fax advertisement, without more, does not give a plaintiff Article III standing to bring a Telephone Consumer Protection Act (“TCPA”) claim.
The Eighth Circuit’s decision requires that the alleged injury be “traceable” to statutory non-compliance. In other words, the plaintiff must show a causal connection between the harm she suffered and the defendant’s TCPA violation.
By way of background, the TCPA and FCC’s TCPA regulations prohibit unsolicited fax advertisements unless they contain a notice that gives the recipient certain information that would allow it to opt out from future faxes. Here, St. Louis Health Center sued pharmaceutical manufacturer Nomax, Inc. for: (1) sending fax advertisements without the plaintiff’s consent; and (2) failing to provide a proper opt-out notice on each advertisement.
After removing the case to federal court, Nomax moved to dismiss for lack of Article III standing. To establish Article III standing, a plaintiff must show “(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.” Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016).
Following the Supreme Court’s decision in Spokeo, there has been considerable discussion among courts and commentators about plaintiffs’ ability to bring TCPA claims based on technical non-compliance.
The Eighth Circuit entered the debate and rejected plaintiff’s standing arguments.
First, the Eighth Circuit found that the plaintiff’s alleged statutory injury did not arise from a lack of consent, because plaintiff’s proposed class definition included faxes for which consent did, in fact, exist. Plaintiff also conceded that its lawsuit “is not based upon the fact that consent was not given.”
Next, the Eighth Circuit rejected plaintiff’s argument that failure to provide a proper opt-out notice created an Article III injury by raising the cost of paper and toner, occupying phone lines, and invading plaintiff’s privacy. The court found that the injury was not traceable to the statutory violation. Because the fax advertisements contained check boxes and return fax contact information (fax number, telephone number, name, and email address), which gave plaintiff enough information to opt out of future faxes, the Eighth Circuit reasoned that the alleged injury would have resulted regardless of whether the opt-out notice was technically compliant or not.
Finally, the Eight Circuit also rejected the alternative argument that the failure to provide a TCPA-compliant opt-out notice was itself the injury (thus eliminating the traceability issue).
With this decision, the Eighth Circuit joins a growing number of courts that have held that a mere “technical violation” of the TCPA does not create Article III standing if the TCPA violation is not traceable to the injury the plaintiff suffered.
Our TCPA Working Group brings together more than 25 attorneys in our litigation, communications, commercial, and privacy practice areas. We provide regular TCPA counseling to clients from a broad range of industries, including technology, healthcare, communications, transportation, and financial services. We have secured dismissals and nominal settlements for clients in TCPA actions and have worked with the FCC to clarify rules addressing a number of key TCPA issues. We also have significant experience in TCPA appeals.
The authors thank Ryan Thompson for his assistance in preparing this article.
On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their joint task force regarding the availability of authorised medicines for human and veterinary use.
The HMA-EMA task force was created to develop and coordinate actions on the availability of human and veterinary medicinal products authorised in the EU. It establishes links with existing working groups and ensures that any activities related to the availability issues in their field are reflected in their respective work programmes.
The present work programme includes a number of actions and deadlines concerning how the HMA-EMA task force plans to address the problem of shortages of medicinal products in the EU. This includes potential shortages that could occur as a result of the UK’s withdrawal from the EU. These actions were agreed in February 2017 but were only published in the course of August 2018.
Lack of availability of medicinal products in the EU either because the products are not marketed or due to supply disruptions has been identified by the EMA and HMA as an area of a great concern. According to the work programme, shortages of medicinal products can have a significant impact not only on the supply chain but also ultimately on healthcare systems and on end-users.
The HMA-EMA task force has set itself a deadline for the fourth quarter of 2019 to encourage accelerated procedures by mutual recognition to extend marketing authorisations to countries where companies would not normally seek marketing authorisation. By that time, the task force also intends to facilitate and promote the use of multilingual packages to enable the transfer of medicinal products with the appropriate translation of the package leaflet to EU Member States that are experiencing shortages, in particular smaller markets. The task force also plans to review the existing procedure for withdrawal of medicinal products in the EU and explore the need for a transition period to allow better planning for any disruptions.
One action of the work programme has already been completed. The HMA-EMA task force has already facilitated the approval of generics and biosimilars through the implementation of joint evaluation (work sharing) and shortened timetables for renewals of marketing authorisations and variation applications.
Other key actions for the task force include development of a concept of reportable shortages by agreeing an EU-wide definition of “shortage” of medicinal products, development of guidance for companies on reporting of shortages, and steps to encourage them to develop best practices to prevent shortages.
Concerns have been expressed regarding the supply of medicinal products in the EU after the UK leaves the EU. As part of the work programme, the HMA-EMA task force has prepared actions to avoid potential risks of shortages resulting from Brexit. The task force intends to provide practical guidance concerning the implementation of required regulatory changes following Brexit, including change of the “reference Member States” for mutual recognition and decentralised authorised products. The task force will also monitor the implementation of these regulatory changes and take steps to minimise disruption of the supply of medicinal products and avoid shortages as a result of Brexit. Planned steps include a review of existing guidance documents for competent authorities regarding how best to manage and minimise the impact of shortages, including the shortages that may arise as a result of Brexit.