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Focus on Regulation

Supreme Court Remands EPA Mercury and Air Toxics Standards (“MATS”) for Failing to Consider Costs

On June 29, 2015, the United States Supreme Court ruled that the Environmental Protection Agency (“EPA”) erred by failing to consider costs when deciding whether it was “appropriate and necessary” to regulate emissions of mercury and other hazardous air pollutants from power plants. See Michigan v. EPA, U.S., No. 14-46, slip op. (June 29, 2015). The Supreme Court’s decision overturned a 2014 ruling by the U.S. Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”), which held that EPA’s decision not to consider costs in the initial stages of the Mercury and Air Toxics Standards (“MATS”) rulemaking process was reasonable. See White Stallion Energy Ctr. LLC, v. EPA, No. 12-1100, slip op. (D.C. Cir. Apr. 15, 2014). The petitioners in the case were a collation of 21 states led by Michigan, the National Mining Association, and the Utility Air Regulatory Group.

Section 112 of the Clean Air Act (“CAA”) commands EPA to regulate hazardous air pollutants from several industrial categories, including power plants. However, Section 112(n)(1)(A)—the provision at issue in the case—directs EPA to perform a study of the hazards to public health reasonably anticipated to occur as a result of emissions from power plants, and to regulate such units under Section 112 only if EPA finds such regulation is “appropriate and necessary” after considering the results of the study. See 42 U.S.C. § 7412(n)(1)(A). Pursuant to this mandate, EPA conducted a public health study—without considering costs—that concluded that it was “appropriate and necessary” to regulate power plants’ emissions of mercury and other hazardous air pollutants. Costs were considered in the standard-setting phase of the rulemaking and as part of the internal Executive Branch review of the rule overseen by the Office of Management and Budget (“OMB”), but not in the initial decision to regulate.

Justice Scalia, writing for the majority, held that even considering the significant level of deference afforded to federal agencies in interpreting ambiguous laws, EPA “strayed far beyond those bounds” when it read Section 112(n)(1) of the Clean Air Act to mean that it could ignore costs when initially deciding whether to regulate power plants. According to Scalia, “[o]ne would not say that it is even rational, never mind ‘appropriate,’ to impose billions of dollars in economic costs in return for a few dollars in health or environmental benefits.’” Michigan v. EPA, No. 14-46, slip op. at 7. Scalia was joined in the 5-4 majority by Chief Justice Roberts and justices Kennedy, Thomas and Alito.

Justice Kagan wrote a dissenting opinion on behalf of the other four members of the court, highlighting the fact that although EPA’s initial decision to regulate hazardous air pollutants from power plants did not take into consideration costs, “EPA later took costs into account again and again and . . . so on.” Michigan v. EPA, No. 14-46, slip op. at 2 (Kagan, J., dissenting). Justice Kagan maintained that “[t]he Agency acted well within its authority in declining to consider costs at the opening bell of the regulatory process given that it would do so in every round thereafter—and that the emissions limits finally issued would depend crucially on those accountings.” Id. at 3.

The impact of the Supreme Court’s decision on the regulated community remains unclear, as the Supreme Court remanded the decision back to the D.C. Circuit for further proceedings. There are two principal options that the D.C. Circuit will consider: remand and vacatur. A remand would allow the MATS rule to remain in effect while EPA addresses the deficiencies outlined by the Supreme Court. A vacatur, in contrast, would nullify the rule completely. EPA and environmental groups have already signaled their intent to argue for remand. The position of the utility industry is difficult to gauge because of the potential impact of a MATS vacatur on the imminent litigation over the legality of EPA’s proposed Clean Power Plan, though it may seek vacatur.

Whether MATS remains in effect will have a significant impact on the operational and capital investment decisions of several power plants. The D.C. Circuit’s decision is not expected for at least ten months, though industry petitioners may request expedited consideration given the legal quagmire the Supreme Court’s ruling has created.

U.S. Government Steps Up Cybersecurity Efforts With New Rules for Export Controls, Economic Sanctions

With cybersecurity dominating the headlines, the U.S. government has taken several recent steps to target the national security threat posed by cybercriminals and hackers with new regulations aimed at curbing malicious actors online.

Read More: U.S. Government Steps Up Cybersecurity Efforts With New Rules for Export Controls, Economic Sanctions

E-commerce liberalization in China: State Council and MIIT push forward

China’s regulatory framework for foreign investment in the e-commerce industry has undergone significant liberalization. Previous pilot programs on a local level have been extended nationwide, with directives from the highest political level to remove restrictions.

On 19 June 2015, the Ministry of Industry and Information Technology issued a notice to lift foreign ownership restrictions in the e-commerce sector, subject to certain existing rules. A day later, the State Council issued guidance to encourage the development of cross-border e-commerce flows, a wider initiative to push China’s e-commerce champions to expand overseas.

For the full alert, please click here.

Potential Impact of the Draft EU Data Protection Regulation on the Life Sciences Sector

On 15 June 2015, the Council of the European Union (“Council”) adopted its position on the draft Proposal for a Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (“Draft Regulation”).

This article discusses certain aspects of the Draft Regulation which could impact the conduct of clinical trials and other activities conducted by healthcare companies that involve the processing of personal data and personal health data. Such revisions merit consideration for the healthcare industry, sponsors of clinical trials, contract research organisations (“CROs”) and other relevant stakeholders.

Scope of application of the Draft regulation

The Draft Regulation will apply to personal data processed by data controllers established in the European Union (“EU”) and to data controllers established outside the EU that process personal data pertaining to individuals residing in the EU in relation to:

- the offering of goods or services to individuals in the EU, irrespective of whether payment is required; or

- the monitoring of the behaviour of such individuals as far as their behaviour takes place within the EU.

While the Draft Regulation does not elaborate on the concept of monitoring the behaviour of individuals, it can be concluded that medical devices which monitor the behaviour of individuals would fall within the scope of the Draft Regulation where such devices process personal data related to persons residing in the EU. This conclusion would apply even if such devices are manufactured by entities that are established outside the EU.

Informed consent

Pursuant to the Draft Regulation, data controllers would be bound by more pronounced obligations than those in the current Data Protection Directive in relation to the information to be provided to data subjects prior to obtaining their informed consent for processing personal data. For instance, such requirements apply to sponsors of clinical trials who are required to obtain the informed consent of the patient prior to the conduct of the clinical trial.

In addition to the requirements provided the current Data Protection Directive, the Draft Regulation requires the following information to be provided to data subjects prior to obtaining his or her informed consent:

- the legal basis on which the processing of the data is permitted;

- the existence of the right to request access, rectify, erase or restrict the processing of their personal data;

- the existence of the right to withdraw consent at any time, without affecting the lawfulness of any processing conducted prior to the withdrawal; and

- the right to lodge a complaint to the competent data protection authority.

Data controllers must also inform data subjects of any automated decision making which produces legal effects concerning the data subject or significantly affects him or her. Moreover, data subjects must be informed of the procedure governing such processing, the significance and envisaged consequences of the processing. Automated decision making includes the concept of “profiling” which is defined in the Draft Regulation as:

“any form of automated processing of personal data consisting of using those data to evaluate personal aspects relating to a natural person, in particular to analyse and predict aspects concerning performance at work, economic situation, health, personal preferences, or interests, reliability or behaviour, location or movements.”

Any automated processing of personal data to analyse and predict the health or behaviour of a patient would, therefore, require the provision of detailed information concerning the method, the significance and the consequences of such processing to the data subject.

Data concerning health and genetic data

The Draft Regulation maintains the restrictions imposed by the Data Protection Directive on the processing of sensitive personal data such as health data.

However, the Draft introduces a specific definition of personal health data. Data concerning health is defined as:

“data related to the physical or mental health of an individual, which reveal information about his or her health status.”

Included in the concept of sensitive personal data is genetic data. The restrictions governing the processing of personal health data will also be applicable to genetic data. Genetic data is defined as:

“all personal data relating to the genetic characteristics of an individual that have been inherited or acquired, (…) which give unique information about the physiology or the health of that individual, resulting in particular from an analysis of a biological sample from the individual in question.”

The Draft Regulation permits the EU Member States to maintain or introduce further restrictions or conditions concerning the processing of personal health data or genetic data. Healthcare companies would, when processing personal health or genetic data, be required to take into account both the provisions of the new Draft Regulation and those laid down at a national EU Member State level governing personal health data or genetic data.

Impact assessments

Pursuant to the current Draft Regulation, data controllers would no longer be required to submit a notification to the competent data protection authorities prior to the conduct of any processing activities.

However, Article 33(1) of the Draft Regulation would require data controllers to perform an impact assessment prior to the processing of certain data which is likely to result in a high risk to the protection of the rights and freedoms of data subjects. The Draft Regulation includes a non-exhaustive list of certain types of data which requires a prior impact assessment including:

· processing of data based on profiling and on which decisions are based that produce legal effects concerning data subjects or severely affect data subjects; and

· processing of sensitive personal data such as health data in circumstances where the data is processed for the purposes of taking decisions concerning data subjects on a large scale.

The assessment would include, at least, an analysis of the risks to the rights and freedoms of data subjects, the measures envisaged to address the risks, safeguards, security measures and mechanisms to ensure the protection of personal data and to demonstrate compliance with the Draft Regulation. Moreover, as part of this impact assessment, data controllers must consult and seek the views of the data subjects on the intended purposes of such processing.

If, the conclusion of such impact assessment is that the processing would result in a high risk to the rights and freedoms of data subjects and the measures taken by the data controller would not mitigate such risks, the data controller must consult the competent data protection authority.

If the competent data protection authority considers that the processing would not comply with the provisions of the Regulation, the competent authority may provide written advice to the data controller concerning any potential steps to remedy the breach. Moreover, the competent authority may impose a number of enforcement measures such as:

· order the data controller or data processor to comply with the provisions of the Regulation;

· order the rectification, restriction or erasure of personal data and communicate such actions to those to whom the data has been disclosed;

· impose a temporary or definitive limitation on processing activities;

· order the suspension of transfer of personal data to a recipient in a third country; or

· impose an administrative fine.

The competent data protection authority has a maximum period of six weeks to issue its advice or impose enforcement measures. This period can be extended for a further six weeks due to the complexity of the case. The data controller will be informed of any such extension.

Transfer of data outside the EEA

Similar to the Data Protection Directive, transfers of personal data outside the EEA are only permitted if performed within appropriate safeguards. The Draft Regulation has, however, introduced a number of new mechanisms by which transfers of personal data are permitted outside the EEA. This includes the transfer of personal data to entities established outside the EEA if such entitles adhere to an approved code of conduct together with binding and enforceable commitments to apply the appropriate safeguards in the code of conduct.

The codes of conduct can be developed by associations and other bodies representing categories of controllers or processors. Such codes must be approved by the competent data protection authority. A relevant expert body with the expertise in relation to the provisions of the code of conduct and which is accredited by the competent data protection authority for such purposes will monitor the application of the codes of conduct. Approved codes of conduct will be made publically available.

The expert body responsible for monitoring compliance with the code of conduct may take a number of enforcement actions including suspension or expulsion of any data controller or data processor from adherence to the code and inform the competent data protection authority concerning any enforcement measures taken.

Sanctions

The Draft Regulation permits the competent data protection authority to undertake a number of sanctions in relation to any breach of the provisions of the Draft Regulation. This includes a range of monetary penalties. The maximum monetary penalty imposed could be up to €1,000,000 or two percent of the total of the previous annual worldwide turnover of a data controller or data processor for any intentional or negligent beach of the Draft Regulation.

Next steps

A final text of the Draft Regulation must be agreed concurrently by the Council, the European Commission, and the European Parliament during. This is known as the “trilogue”. It is expected that a final text could be agreed upon by the EU Institutions by the end of 2015.

We will continue to further monitor the trilogue as it cannot be excluded that the Draft Regulation will be substantially amended prior to final adoption.

The Council Adopts Its Position On Revised Medical Devices Package

On 19 June 2015, the Council of the European Union (“Council”) came to a common position, during a meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), on two draft Regulations intended to replace the current Medical Devices Directive[1], the Active Implantable Medical Devices Directive[2], and the In Vitro Diagnostic Medical Devices Directive[3].

The draft Regulations were published by the European Commission on 26 September 2012. The European Parliament proposed amendments to the Commission’s texts on 22 October 2013 following a vote in plenary session. The Council has discussed the proposals of the Commission since this vote.

During the EPSCO meeting on 19 June 2015, all EU Member States, except Germany and Poland agreed, to validate, as a package, the amendments[4] prepared by the Council to the original texts of the European Commission.

If the proposed Regulations are adopted in their current form, they will lead to an overhaul of the current regulation of medical devices and in vitro diagnostic medical devices in the European Union (“EU”). Many new provisions would be introduced by the draft Regulations. An outline of some of the most noteworthy proposals concerning the medical devices industry is provided below.

Products without medical purposes

The Council has proposed to extend the scope of the Regulation on medical devices to groups of products which are not intended to have a medical purpose. These products would be listed in Annex XV of the Regulation and include contact lenses or other articles intended to be introduced into or onto the eye. Equipment intended to be used to reduce, remove or destroy adipose tissue such as equipment of liposuction, lipolysis or lipoplasty would also be included in this Annex.

The Council has proposed that Common Specifications be adopted for these groups of products taking into account the state of the art and existing standards for analogous devices with a medical purpose.

New procedure for certain high risk medical devices

As in the Commission’s proposals and the related Parliament amendments, the Council has proposed that the current conformity assessment procedure be strengthened for high risk medical devices. However, the Council proposed that the scope of this procedure be more limited than that proposed by the Parliament. The Parliament proposed that this procedure apply to implantable Class III devices, Class IIb devices intended to administer and/or remove a medicinal product, devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable and Class D in vitro diagnostic medical devices where no common technical standard exists. The Council took the view that the procedure should apply only to implantable Class III medical device and Class D IVDs.

For implantable Class III medical devices, the procedure would be as follows:

  • The manufacturer’s notified body would prepare a clinical evaluation assessment report concerning the clinical evidence provided by the manufacturer taking into account the benefit/risk determination, the consistency with the intended purpose and the post-market clinical follow up plan;
  • This clinical evaluation assessment report must then be transmitted to the European Commission which would communicate the report to an expert panel;
  • The expert panel would provide a scientific opinion concerning the clinical report to the notified body; and
  • The notified body would give due consideration to the views expressed by the expert panel. If necessary, the notified body may advise the manufacturer to restrict the purpose of the device to certain numbers or groups of patients, to limit the duration of validity of the certificate, to undertake specific post market clinical follow-up studies, to adapt the instructions for use or the summary of safety and clinical performance or impose other restrictions in its conformity assessment report.

The scrutiny procedure would not be required if:

  • The device has been designated as a modification of a device already marketed in the EU by the same manufacturer for the same intended purpose if the modifications have been demonstrated by the manufacturer and accepted by the notified body as not adversely affecting the benefit/risk ratio; and
  • The principles of the clinical evaluation of the device type or category have been addressed in Common Specifications and the notified body confirms that the clinical evaluation of the manufacturer for this device is in compliance with the relevant Common Specifications.

For Class D IVDs, the revised proposal would require the manufacturer’s notified body to prepare a performance evaluation assessment report. The notified body would then request a reference laboratory to verify whether the performance of the device complies with the available Common Specifications and with the state of the art. The verification would include laboratory tests by the reference laboratory. The notified body would be required to give due consideration to the views expressed in the scientific opinion when making its decision. The notified body would not deliver the CE Certificate of Conformity if the scientific opinion is unfavourable.

Single-use devices and reprocessing of devices

According to the draft Regulation on medical devices as amended by the Council, reprocessing and further use of single-use devices may take place only when permitted by the EU Member States. The European Commission would also be required to establish and regularly update a list of categories or groups of single-use devices which cannot be reprocessed safely and may, therefore not be reprocessed.

The view of the Council concerning the reprocessing of medical devices is rather different from the views of the Parliament. Parliament proposed that medical devices would be considered as suitable for reprocessing and as reusable devices by default, unless they are placed on a list of single-use devices which are unsuitable for reprocessing.

As with the Parliament’s proposal, the Council also considered that any natural or legal person who wishes to reprocess a single-use device in order to make it suitable for further use, must be considered as the manufacturer of the reprocessed device and be held liable for its reprocessing activities. The Council, however, introduced an exception to this principle for single use devices reprocessed and used within a health institution.

Clinical investigations

Manufacturers of Class III medical devices would be empowered to consult with an expert panel prior to the commencement of a clinical evaluation and/or investigation. The role of the expert panel would be to review the manufacturer’s intended clinical development strategy and proposals for clinical investigations. The opinions expressed by the expert panel would form a part of the clinical evaluation report to be submitted as part of the technical document.

The Council has also proposed that manufacturers of implantable devices and devices falling within Class III be permitted to rely on clinical data concerning an equivalent device if:

  • The device has been designated as a modification to a device already marketed by the same manufacturer and accepted by the notified body as being equivalent to the marketed device;
  • The clinical evaluation is sufficient to demonstrate conformity with the relevant safety and performance requirements.
  • The manufacturer has access to the technical documentation of the other manufacturer on an on-going basis through a written agreement.

In these circumstances, the notified body shall determine whether the post market clinical follow-up plan is appropriate and include post market studies to demonstrate the safety and performance of the device.

European Authorised Representative

The Council has proposed additional responsibilities for the European Authorised Representative appointed by a manufacturer which is not established in the European Economic Area. In the view of the Council, the European Authorised Representative should be responsible for verifying that the EU Declaration of Conformity and technical documentation have been drawn up by the manufacturer and, where applicable, that an appropriate conformity assessment procedure has been conducted by the manufacturer. In the Council’s views, the European Authorised Representative should not only have access to the technical documentation but also keep a copy of this documentation.

If adopted, the addition of this task to the current role of the European Authorised Representatives would substantially amplify the role and responsibilities of European Authorised Representative in the EU who would be legally liable for defectives devices placed on the EU market if the medical devices were not compliant with the requirements of the Regulations.

Person responsible for regulatory compliance

All manufacturers would be required to appoint a person responsible for regulatory compliance. This person would have the “requisite expertise” in the field of medical devices which may be demonstrated by appropriate qualifications or professional experience in Regulation for medical devices.

However, micro and small enterprises would not be required to employ a person for regulatory compliance within their organisation. Rather, there would be a requirement to ensure that such a person remains both permanently and continuously at the disposal of the micro and small enterprise.

European Authorised Representatives would be also required pursuant to ensure that at least one person remains at the disposal of the organisation and is responsible for regulatory compliance activities. Such availability must be on a permanent and continuous basis. However, such person would not be required to be an employee of the European Authorised Representative.

Next steps

Although an agreement was reached by the Council concerning the proposed amendments to the proposed Commission Regulations, the Council must still prepare and agree on the recitals of the proposed Regulations. When the recitals are finalised, trialogue negotiations between the Council, the European Parliament and the European Commission are expected to start. This trialogue is expected to begin in autumn 2015. Depending on the outcome of the trialogue, the Regulation on medical devices and the Regulation on in vitro diagnostic medical devices could be definitively adopted in mid-2016.

If adopted, the Regulation on medical devices would be applicable three years after its entry into force. For the Regulation on in vitro diagnostic medical device, the Council has proposed a five years transition period.

 

[1]              Directive 93/42/EEC concerning medical devices

[2]              Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices

[3]              Directive 98/79/EC on in vitro diagnostic medical devices

[4]              MDR:     http://data.consilium.europa.eu/doc/document/ST-9769-2015-INIT/en/pdf (Chapters); http://data.consilium.europa.eu/doc/document/ST-9769-2015-ADD-1/en/pdf (Annexes)

 

IVDR:     http://data.consilium.europa.eu/doc/document/ST-9770-2015-INIT/en/pdf (Chapters); http://data.consilium.europa.eu/doc/document/ST-9770-2015-ADD-1/en/pdf (Annexes)

 

U.S. FOREST SERVICE WITHDRAWS PROPOSED GROUNDWATER GUIDANCE: Sometimes the Government Listens

A concise Friday announcement in the Federal Register, 80 Fed. Reg. 35,299 (June 19,2015), brings notice that the U.S. Forest Service has abandoned plans for major revisions of its groundwater management policy, Forest Service Manual 2560, at least for the time being.

Although the Forest Service attributed its reversal to a determination that the “proposal does not adequately meet its needs,” the new language had drawn widespread criticism from stakeholders outside of the agency, including the Congress, western states and groundwater permittees. The criticism was based largely on a perception that the Forest Service intended to expand its jurisdiction into the management of groundwater resources that heretofore had been the sole regulatory province of the states. The Forest Service has long exercised a degree of control through the issuance of special use permits for groundwater withdrawals from beneath Forest Service land, usually related to maintenance of forest health, but cannot deny reasonable access to holders of state-sanctioned subsurface rights. However, the proposed revisions were seen as imposing more stringent standards for the issuance of such permits, and extending Forest Service jurisdiction to aquifers which lie, in whole or part, beyond the boundaries of National Forests.

Speaking for the Western Governors Association, Jim Ogsbury told the House Committee on Natural Resources in April that WGA opposed those elements of the Forest Service proposal which appeared to encroach upon the states’ regulatory prerogatives. The states, he said, “are primarily responsible for water supply planning within their boundaries.” The American Bottled Water Association [a Hogan Lovells client], some of whose members are Forest Service permittees, emphasized the multiple-use mandate of the Forest Service. In its comments on the proposed revisions, ABWA expressed concern that the Proposed Directive “assigns first priority to protection of groundwater among [the Forest Service’s] multiple responsibilities for resource management,” including sustainable withdrawal and use of groundwater.

The Forest Service appeared to deflect these arguments in its withdrawal of the Proposed Directive: it said that “the proposed directives did not, and any future actions will not, infringe on state authority, impose requirements on private landowners, or change the long-standing relationship between the Forest Service, States and Tribes on water.” At the same time, the Forest Service announced that it will start over, “to develop new proposed directives to create a consistent approach to evaluating and monitoring effects to groundwater resulting from actions on NFS lands.”

EMA Updates Product Information Templates for Medicinal Products for Human Use

On 10 June 2015, the European Medicines Agency published the revised Human Product Information templates for medicinal products in the European Union (“EU”). The revised Quality Review of Documents (“QRD”) template concerning centralised procedures is most notably affected by this update. The update introduces certain modifications to the Human Product Information template and is intended to provide guidance for applicants and marketing authorisation holders (“MAHs”).

In the EU, certain elements of product information are required as part of the marketing authorisation requirements and post authorisation measures for medicinal products for human use. This includes information contained in the Summary of Product Characteristics (SmPC), the Labelling and Package Leaflet.

Summary of Product Characteristics

According to the revised QRD template, the use of combined SmPCs for different strengths of the same pharmaceutical form could be permitted where the SmPCs are identical. If, however, the therapeutic indications are different for the different strengths the applicant could present the SmPCs in a single document for the evaluation process only. The applicant will subsequently be required to provide a separate SmPC for each strength and pharmaceutical form containing all pack-sizes.

Annex I Section 9 to the revised QRD template for centralised procedures defines the dates that must be recorded by MAHs. As such, the following points must be observed:

i) The date of the initial marketing authorisation of the medicinal product must reflect the initial date of the Commission Decision regarding the marketing authorisation; and

ii) The date of the (conditional) renewal of the concerned medicinal product must reflect the actual date of the Commission Decision.

With regard to the preparation of radiopharmaceuticals, Annex I Section 12 highlights that a link to the competent authority of the relevant EU Member State is optional and must only be displayed on the final printed materials. Subsequently, it will not be necessary to provide the link in the Product Information Annexes.

Obligations of the Marketing Authorisation Holder

Annex IIC to the revised QRD template provides new statements with regard to periodic safety update reporting. The MAH must choose either the European birth date or international birth date of the medicinal product. The selected birth date will constitute the basis of the data lock point for the first period update report (“PSUR”).

In accordance with Annex IID to the revised QRD template, the MAH must state whether the post-authorisation measure is a post-authorisation efficacy study (“PAES”) or non-interventional post-authorisation safety study (“PASS”).

Labelling and Package Leaflet

Annex III to the revised QRD template provides guidance on the provision of quick response (“QR”) codes. If the QR code is included in the packaging material and/or the Package Leaflet, the choice of location must ensure readability. Reference to the QR code must be detailed in Annex IIIA and/or Annex IIIB as “QR to be included” and followed by the corresponding URL. This reference will be designated in accordance with the information provided.

Annex IIIB Section 6 to the revised QRD template provides that the printed Package Leaflet must contain the sole contact details of the local representative of the marketing authorisation holder in the relevant EU Member State where the medicinal product is sold. Previously, this information was required for all local representatives. Nevertheless, there still remains an obligation to provide the full list of local representatives in the Product Information Annexes.

Timeframe for Implementation of revised QRD Template

In a separate guidance document the EMA outlines the implementation plan for the revised QRD template concerning centralised procedures. The guidance provides the following instructions:

(i) With regard to on-going marketing authorisation applications, the revised QRD template must be implemented as soon as possible. The final date for complying with the changes must be Day 181 of the marketing authorisation procedure;

(ii) Applicants who submit a new marketing authorisation application after 10 June 2015 must respect the revised QRD template immediately. If, however, a new marketing authorisation application is due to be submitted within two (2) months from the date of publication of the revised QRD template, this requirement will not apply. Applicants will be required to comply with the revised QRD template at a later date (Day 121) of the marketing authorisation procedure; and

(iii) Current MAHs are recommended to update their Product Information Annexes at the first available opportunity. This could be achieved when an application for a line extension or variation to the existing marketing authorisation is submitted. Alternatively, MAHs will be required comply with the revised QRD template on the date of the renewal of the marketing authorisation. If, however, such opportunities do not arise, MAHs must recognise the changes reflected in the QRD template within 3 years from the date of the publication of the revised QRD template.

Applicants and MAHs are recommended to consult with their respective Procedure Manager in view of the discussed changes introduced by the QRD template and the timeframe for compliance.

New UK Registration Requirements for Online Medicine Retailers

From 1 July 2015, any UK-based online retailer that sells medicines to consumers in the UK or any EU or European Economic Area (EEA) country must be registered with the UK competent authority, the Medicines and Healthcare Products Regulatory Agency (MHRA). They must also display the EU common logo for online retailers and pharmacies, together with a hyperlink to the retailer’s entry in the MHRA’s list of registered retailers, on every page of the website that offers to sell medicines to the public. These requirements also apply to companies selling medicines through a third-party market place website.

Only one company can be named on each registration, but multiple websites can be registered against that company’s registration. The MHRA’s timeline for processing registration applications is 90 working days.

In the UK, registered pharmacies can sell general sales list and pharmacy (“over-the-counter”) medicines or supply prescription-only medicines dispensed against a prescription online. All other retailers can only sell general sales list medicines online. In addition, the medicines being offered online must be licensed in the EU Member State where the consumer purchasing that medicine is based.

The aim of the new requirements is to help the public check whether the website they are visiting can legally sell medicines and reduce the risk of buying counterfeit products.

The EU common logo was introduced under the Falsified Medicines Directive 2011/62/EU. The European Commission has published technical guidance on using the EU common logo: http://ec.europa.eu/health/files/eu-logo/logosancointernet_charte_v2.pdf
For further information on the UK requirements see: https://www.gov.uk/register-for-the-eu-common-logo

FCC Clarifies TCPA Requirements, Creating New Burdens on Callers

Today, the Federal Communications Commission (FCC) adopted a Declaratory Ruling and Order clarifying a number of unsettled issues under the Telephone Consumer Protection Act (TCPA).  The decision, which has not yet been released, is in response to more than twenty petitions seeking clarification.  The vote was 3-2 along party lines and is expected to have a significant impact on a range of industry sectors.

The FCC also issued a news release for the decision.  We will provide an update after the FCC releases the decision.