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Focus on Regulation

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

On 28 May 2018, the European Commission has published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products[1]. This proposal is intended to modify the EU rules on Supplementary Protection Certificate (SPC) and allow EU generic and biosimilar companies to manufacture versions of medicinal products still protected by a SPC, provided that the products were intended solely for sale outside the EU.

SPCs are an intellectual property right scheme introduced in the EU in 1992 that provide an extension to patent rights for medicinal products. The SPCs are intended to offset the loss of effective patent protection for medicinal products that occurs due to the time necessary to complete the obligatory procedures prior to grant of related marketing authorisation. An SPC can extend a patent right for a maximum of 5 years following grant of marketing authorisation.

At the moment, during the SPC period for a medicinal product in the EU, EU-based manufacturers of generic or biosimilar medicinal products cannot manufacture for any purpose. In addition, the SPC is considered by some to make it challenging for EU manufacturers of generics and biosimilars to enter the EU market immediately after the expiry of the SPC, since they have not built up production capacity before expiry of the SPC. The same is thought not to be true of manufacturers based in non-EU countries, where patent protection may not exist or has expired. According to the European Commission, this situation creates a major competitive disadvantage for EU-based companies and entails a risk of delocalisation of manufacturing and loss of investment in the EU.

According to the European Commission, many SPCs will expire from 2020. This may lead to a significant number of generics and biosimilars entering the EU market. The European Commission considers that there is an urgent need to adjust the existing SPC Regulation to address this situation. The Institution has, therefore, proposed a targeted amendment to the SPC rules to introduce an export manufacturing waiver.  This waiver would provide EU based companies will have entitlement to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the SPC provided this manufacture is solely for the purpose of export to a non-EU market where patent protection for the innovative medicinal product has either expired or has never existed. The European Commission’s proposal would also address the EU day-1 entry issue. The proposal is anticipated to contribute to the possibility for a manufacturer that has set up a manufacturing line for export purposes to more easily, following expiry of an SPC,  use the same line to manufacture generics or biosimilars with a view to swiftly supplying the EU market.

The European Commission’s proposal includes a series of safeguards intended to create transparency and prevent medicinal products that infringe IP rights based on SPCs from entering EU Member States markets. The proposal provides that manufacturers intending to start manufacturing for export purposes must notify the competent industrial property office of the EU Member State which granted the basic patent and in which the market authorisation was obtained. The information contained in that notification will be made public. The manufacturers will also need to comply with due diligence requirements, chiefly to prevent goods manufactured for export from being diverted onto the EU market. Manufacturers will be required to fully inform their contracting parties in charge of the manufacture or export of the products that the products in question are only intended for export and that placing the products on the EU market, import or re-import of these products into the EU may infringe the SPC.

The Proposal provides that any export of SPC-protected products out of the EU will be subject to compliance with specific labelling requirements. This will include affixing a logo (“EU Export”) to the outer packaging of the product. The logo is intended to facilitate the identification of the products as exclusively intended for the purpose of export to countries outside the EU.

The European Commission claims that the combined effect of these safeguard measures will create transparency and prevent products that infringe intellectual property rights from entering the EU market. According to the European Commission, the proposal will make it easier for SPC holders and public institutions to detect and fight such infringements through  means of judicial redress available under existing legislation governing the enforcement of Intellectual Property Rights.

The proposed Regulation, if adopted in its current form, will apply only to SPCs granted after the date of application of the Regulation. The new rules would also apply to applications for SPCs submitted to the competent authorities in accordance with Regulation (EC) No 469/2009 and which remain pending on the date that the proposed Regulation enters into application. An appropriate transitional period will apply to these applications.

[1] European Commission, Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products, 28 May 2018, available at this link.

No Fly Zone: FCC Proposes $2.8 Million Penalty for Marketing Non-Compliant Drone AV Accessories

The Federal Communications Commission is proposing to bring a $2.8 million penalty against HobbyKing for marketing drone-attachable audio/video (AV) transmitters that operate on unauthorized frequencies.

For marketers and retailers of unmanned aircraft systems (“UAS”) and attachable devices, this penalty signals that the FCC is cracking down on the makers and marketers of noncompliant UAS and UAS-attachable devices. This penalty also serves as a reminder to operators, who are required to have an FCC license to operate a drone, even if it only  operates on amateur frequencies. Continue Reading

No Fly Zone: FCC Proposes $2.8 Million Penalty for Marketing Non-Compliant Drone AV Accessories

The Federal Communications Commission is proposing to bring a $2.8 million penalty against HobbyKing for marketing drone-attachable audio/video (AV) transmitters that operate on unauthorized frequencies.

For marketers and retailers of unmanned aircraft systems (“UAS”) and attachable devices, this penalty signals that the FCC is cracking down on the makers and marketers of noncompliant UAS and UAS-attachable devices. This penalty also serves as a reminder to operators, who are required to have an FCC license to operate a drone, even if it only operates on amateur frequencies.

Continue Reading

EMA provides guidance on the sponsor’s role in validating electronic systems used in clinical trials

The European Medicine Agency (EMA) has updated its Good Clinical Practice (GCP) Guideline[1] to clarify the level of validation/qualification that needs to be performed by a sponsor in a clinical trial setting when using an electronic system previously qualified by a vendor. The updated Guideline, issued in the form of a Q&A document, provides that it is the sponsor who is ultimately responsible for validating clinical trial processes that are supported by electronic systems.

In clinical trials settings, the use of electronic systems has proven to be more the standard than the exception. The systems are used for different purposes including data collection, data management, safety data management and evaluation, treatment allocations. A considerable number of electronic case report forms and applications for instance collection of patient related outcome or clinical outcome assessment are provided by, or purchased from, vendors and customised to varying degrees. As a result, the EMA explains that the GCP inspectors receive an increasing number of questions with regard to this topic. In addition, the EMA calls attention to the fact that deviations were given during GCP inspections, regarding the level of validation/qualification needed to be performed by a sponsor when using a system that has already been validated by the supplier.

The updated Guideline is intended to address the situation in which a sponsor uses an electronic system in the manner intended by a vendor. This includes the built-in possibilities for configuration. The electronic system may be a system validated by the supplier, but installed by the sponsor, or a system provided as software-as-a-service (SaaS or cloud solution). However the updated Guideline provides that different requirements will apply for the validation or qualification of electronic systems where the sponsor changes or adds functionalities to the system.

The updated Guideline clarifies that the sponsor is ultimately responsible for validation of the clinical trial processes which is supported by electronic systems. The updated Guideline further specifies that the approach to validation should be based on a risk assessment. This risk assessment must take into consideration the intended use of the system and the potential of the system to affect human subject protection and the reliability of the trial results. It should be justified by the sponsor and documented. The sponsor may rely on qualification documentation provided by the vendor if the qualification activities performed by the vendor have been assessed as adequate. However, the sponsor may also need to perform additional qualification/validation activities based on a documented risk assessment.

The updated Guideline includes a non-exhaustive list of conditions under which the sponsor can use the vendor’s qualification documentation. This includes, for example, that the sponsor has a thorough knowledge about the vendor’s quality system and qualification activities, which will usually be obtained through an in-depth assessment/audit.

According to the updated Guideline, sponsors and vendors should be aware that GCP inspectors could inspect documentation regarding the qualification process. They inspectors may also inspect any other relevant documentation on the e-system maintained at a sponsor level, as well as on the vendor level if the electronic systems are used for generating/handling relevant clinical data or maintain control and oversight of clinical trial processes. This documentation is considered as essential by GCP inspectors and is likely to be requested during GCP inspections. This holds true regardless of whether or not the sponsor contracted out activities related to electronic systems or decided to consider the assessment of the vendor’s systems/processes/documentation as an audit. The updated Guideline provides that GCP inspectors do not consider the documentation or the report of these activities as an audit report.




[1] European Medicines Agency, Q&A: Good clinical practice (GCP), available at this link.

Hogan Lovells launches Practical Guide on Respecting Human Rights in the Energy and Natural Resources Sector at industry event in Johannesburg

How does the responsibility to respect human rights apply to companies operating in the Energy and Natural Resources Sector?  How does this relate to hard legal risk at a domestic and international level and, what practical steps should a business take to fulfil this responsibility and reduce its legal risk?

This morning, we had the pleasure of launching our practical guide on the Responsibility to Respect Human Rights in the Energy and Natural Resources Sector at an industry event in Johannesburg.  The importance of natural resources to the South African economy and the prominence of human rights in the South African constitution and labour law have brought these issues to the fore and it was fascinating to hear diverse perspectives from lawyers, corporate social responsibility experts and senior executives in the sector.

You can download a copy of the brochure here.

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal products and biosimilars

The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders. These include entities involved in the development, manufacture and/ or commercialisation of medicinal products for human use, in particular biological medicinal products and biosimilars, patient groups, healthcare professionals as well as insurance and procurement agencies.

The objective of this targeted stakeholder consultation is to collect the views of interested parties on the impact of duplicate marketing authorisations of biological medicinal products on the availability of biosimilars to healthcare professionals and patients.

Annex I of the Note on the handling of duplicate marketing authorisation applications[1], Section 1 regarding “public health reasons” provides that “the first introduction of a generic product by the holder of the reference medicinal product can also improve the availability of a medicinal product. This is because of the first entry of a generic to the market has an impact on availability as it usually increases its accessibility“.

In the EU, companies can apply for a duplicate marketing authorisation in exceptional circumstances. This would include when there are objective, verifiable reasons relating to public health regarding to the availability of medicinal products to healthcare professionals and/or patients or for co-marketing reasons.

The European Commission proposes to update Annex I and add the following sentence: “Requests for duplicate marketing authorisation applications need to be properly substantiated and based on sound evidence“. The European Commission provides that on the basis of the experience gained since the publication of the Note, the first introduction of a biosimilar by the holder of a biological medicinal product may not improve availability. The European Commission provides, however, that a case-by-case assessment of the impact on the availability of the product will be undertaken on the basis of evidence provided by the applicant, with due consideration of the impact of duplicate marketing authorisation on the availability of biosimilars to health care professionals and patients.

Since the publication of the Note on handling of duplicate marketing authorisations applications in 2011, the European Commission Services have identified potential issues with regard to the grant of the duplicate marketing authorisations for biological medicinal products on the grounds that they would be a “first generic”. These issues concern the possible impact of such duplicate marketing authorisations on the biosimilar market (including potential anticompetitive effects) and the undermining of treatment options available to patients.

The stakeholders are invited to comment on this consultation by 10 September 2018 at the latest.

[1]  European Commission, Note on the handling of duplicate marketing authorisation applications, October 2011, available at this link

The EMA opens a draft guideline for handling and shipping of investigational medicinal products for human use for public consultation.

On 23 May 2018, the European Medicine Agency (EMA) launched a public consultation for a draft guideline concerning the responsibilities of trial sponsors for handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice.

The draft guideline provides the principles for the two step release and shipping of the investigational medicinal products by the qualified person and the trial sponsor. It also provides a description of the areas of interface between the manufacturer and the sponsor and required contractual agreements.

This draft guideline will complement the Delegated Regulation (EU) No 2017/1569 of 23 May 2017 on Good Manufacturing Practice for investigational medicinal products for human use and the detailed Commission guideline No C(2017) 8179 on Good Manufacturing Practice for investigational medicinal products for human use.

According to the draft guideline, investigational medicinal products should remain within the control of the sponsor until after the completion of the two step procedure. This two step procedure consists of batch certification by the Qualified Person and the regulatory release by the sponsor for use in a clinical trial. The draft guideline states that “both steps should be recorded and retained in the clinical trial master file held by, or on behalf of, the sponsor“.

The draft guideline further provides that regulatory release of the investigational medicinal product by the sponsor should verify that any aspects required for compliance with Clinical Trials Regulation (Regulation (EU) No 536/2014) are in place before investigational medicinal products are shipped to the clinical investigator sites. These checks will vary depending on the related clinical trial. They may, for example, include contracts with investigators and applicable service providers, any local and/or national approvals and if the authorisation of the clinical trial is subject to conditions, that these conditions are met.

With regard to the shipments of investigational medicinal products, the draft guideline provides that “it should be ensured that the shipping of investigational medicinal products minimises any risk while ensuring that the quality of the product is maintained and the applicable elements of guidelines on Good Distribution Practice of medicinal products for human use are taken into consideration“. The shipment of these products should be conducted according to the instructions given by, or on behalf of, the trial sponsor in the shipping order. The draft guideline also provides that temperature control and monitoring of the storage conditions are necessary and that related records should be maintained.

In addition, the draft guideline provides that any deviations from the specific conditions during the shipment of the products should be formally investigated. Responsibility for control of the shipment of investigational medicinal products remains with the trial sponsor or their representative until the product has been received and accepted by the clinical investigator site or pharmacy.

Finally the draft guideline discusses contractual arrangements between the manufacturer and the trial sponsor. The draft guideline provides examples of issues that should be addressed in these contractual arrangements.

Stakeholders are invited to submit their comments on this draft guideline before the 31st of August 2018. More information regarding the public consultation is available at this link.

Institutional Review Board “Checklist” offers tool to help protect clinical trial participants

On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). The agencies are both responsible for issuing and enforcing federal regulations designed to protect human subjects in research, and have been working together to harmonize federal regulatory requirements and guidance in this area. This finalizes draft guidance issued in August 2016, which we summarized here. Continue Reading

UK Government Responds to Brexit Life Sciences Regulatory Recommendations

The UK Government has published a response to the recommendations set out in the Health and Social Care Committee’s Report dated 21 March 2018 on “Brexit: medicines, medical devices and substance of human origin”, which considered the regulatory arrangements needed for the safe and effective supply of medicines and medical devices post-Brexit (see our blog here).

Of particular interest to life sciences companies, the response states that:

  • The safety of patients is of paramount importance to the UK Government’s exit negotiations. The Government is preparing for all potential outcomes but is “increasingly confident that the prospect of a ‘no deal’ scenario is highly unlikely”.
  • The UK Department of Health and Social Care (DHSC) is currently assessing the impact of Brexit on the supply chain for all medicines and devices used in the UK National Health Service (NHS).
  • The Government recognises the importance of a close and cooperative relationship between the UK and EU in relation to medicines and devices regulation. The Government wants to explore the terms on which the UK could remain part of EU agencies, including the European Medicines Agency (EMA).
  • Under the terms of the implementation period (from the UK leaving the EU in March 2019 until the end of 2020), the UK will no longer be an EU Member State but businesses will be able to trade on the same terms as now until the end of 2020. This includes that the EU will continue to accept UK batch testing, release and inspections, UK-based Marketing Authorisation Holders (MAH) and other key roles including QP certification.
  • During the implementation period, the current EU principles and guidelines of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) will continue to apply in the UK. There is no current policy intention for any divergence, though the UK MHRA will have the power to update these principles and guidelines in the future to reflect evolving best practice.
  • In relation to goods, including medicines and devices, the Government’s position is that the UK-EU border should be as frictionless as possible and products should only need to undergo one set of approvals to be sold in both the EU and UK.
  • UK citizens participating in on-going trials in the UK will not be affected by the UK’s exit from the EU or the end of the implementation period.

The full response is available here.

Further negotiation recommendations relating to the pharmaceutical sector were published by the BEIS Select Committee earlier this month (see our blog here).

BHR News Flash: Swiss proposal to impose human rights due diligence requirements reaches the next stage of the legislative process

In December 2017, our blog post discussed how a coalition of Swiss civil society organisations launched the Responsible Business Initiative (“RBI”), i.e. a proposal to amend the Swiss constitution to require mandatory human rights due diligence for companies based in Switzerland.

While the RBI is still currently going through the Swiss legislative process, it seems to be heading towards a national referendum.

Back in November 2017, the Council of States, one of the two parliamentary chambers, issued a counter-proposal to the RBI, to respond to a suggested text it perceived as “too vague” and going “too far”.

After some deliberation by its legal committee, on 4 May 2018 the National Council (i.e. the other Swiss parliamentary chamber) announced that it voted by 14 against 10 to approve the counter-proposal, paving the way for a vote through a federal referendum later this year or early next year.

Stay tuned for more developments on the Swiss RBI.