2013-09-26 Pharmacovigilance and transparency

Pharmacovigilance and Transparency

Wouter Pors

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Pharmacovigilance Seminar

Page 2 © Bird & Bird LLP 2013

Table of contents

Introduction

Section 1 – Transparency regulation

Section 2 – EMA policy

Section 3 – The Dutch Freedom Of Information Act (FOIA)

Section 4 – Case law

Conclusion

Introduction

"Openness and transparency are paramount values enshrined in the Treaty on European Union (TEU) and the Treaty on the Functioning of

the EU (TFEU) as they contribute to strengthen the principles of democracy and good administration"

(EMA, 2010)

Pursuant to Article 15 TFEU, there is a right of access to documents of the EU Institutions, Bodies, Offices and Agencies, according to the principles and further conditions as defined by Regulation (EC) 1049/2001, regarding public access to European Parliament, Council and Commission documents, i.e. the Transparency Regulation



Introduction

• Regulation 1049/2001: Regulation, directly applicable in all Member States

• However, as regards the documents of the national institutions of the Member States, each Member State has its own "Freedom of Information Act"(FOIA)

• In the Netherlands: Wet openbaarheid van Bestuur (WOB)



© Bird & Bird LLP 2013 Pharmacovigilance Seminar

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Section 1 – Transparency regulation

The Transparency regulation

• Any citizen of the Union, and any natural or legal person residing or having its registered office in a Member State, has a right of access to documents of the institutions, subject to the principles, conditions and limits defined in this Regulation.

• ‘document’ shall mean any content whatever its medium (written on paper or stored in electronic form or as a sound, visual or audiovisual recording) concerning a matter relating to the policies, activities and decisions falling within the institution's sphere of responsibility

• This Regulation shall apply to all documents held by an institution, that is to say, documents drawn up or received by it and in its possession, in all areas of activity of the European Union.



Section 2 – EMA policy

EMA policy on access to documents POLICY/0043; 1 December 2010

• Article 73 of Regulation (EC) No 726/2004 provides that the Transparency regulation also applies to documents with the EMA

• Access to a document will be denied only if one of the exceptions of Article 4 of 1049/2001 will be considered applicable

• When only parts of a document contain information that cannot be disclosed, access to the remaining document shall be granted

• Third party consultation: the EMA will always inform the originator prior to disclosure that a request for access has been received

• Only in case of doubt on the confidential nature of the document or parts thereof, the EMA may consult the originator prior to taking any decision on disclosure

• In dealing with requests for access to documents, the EMA will apply the principle of proportionality in order to avoid that the performance of core tasks of the EMA will be jeopardised

• The EMA will liaise with the applicant to seek an agreement on a fair and reasonable solution



HMA/EMA Guidance on Commercially Confidential Information (CCI) and Personal Data (PD) / release of information after the granting of an Marketing Authorisation (March 2012)

• Guidance is intended to be applicable to information requests on medicinal products authorised under the national, mutual recognition, decentralised and centralised procedures

• The document classifies all sections of the MA dossier according to four criteria: CCI: Commercially Confidential Information – as a main rule cannot be released

PD: Personal Data - as a main rule cannot be released or should be redacted

CBC: Case by Case – suggesting a case by case review as possibly contains CCI or PD

CBR: Can be released - after preliminary review



HMA/EMA Guidance

Document gives guidance as what should be considered as CCI/ PD/CBC/CBR

Examples:

• Name company/ applicant EEA: CBC

• Product name: CBR (only if same as final authorised name)

• Active substance/ Pharmaceutical form etc: CBR

• Report on clinical data: CBR

• Pharmacology/ toxicology written summary: CBR

• Manufacturer/ description of manufacturing process: CCI

• Information on outcome of inspections is not regarded as confidential, however specific details, e.g. information regarding facilities and equipment are considered CCI

• Contractual agreements are considered CCI, except contracts between companies and CROs

Point 3.6: "Since pharmacovigilance legislation is currently being revised, we defer this discussion until this work has been completed."



HMA/ EMA guidance HMA/EMEA RECOMMENDATIONS ON TRANSPARENCY RECOMMENDATIONS on the handling of requests for access to Periodic Safety Update Reports (PSURs)

“Commercially confidential information” is generally considered to fall broadly into two categories:

Confidential intellectual property, “know-how”, and trade secrets (including e.g. formulas, programs, process or information contained or embodied in a product, unpublished aspects of trade marks, patents, etc).

Commercial confidences (e.g. structures and development plans of a company).

• The global sales figures are (publicly) available from different providers and therefore cannot be considered commercially confidential

• Safety studies, ongoing and planned as well as relevant scientific literature; the content and level of detail of such studies may vary; therefore it should be assessed on a case by case basis.



PRAC

• The PRAC has been publishing agendas of its meetings since its formation in July 2012. The agendas are published in full with the exception of a few elements that are redacted to take into account the confidential nature of some issue and principles for personal data protection.

• PRAC meeting highlights makes publicly available a selection of information from the PRAC meeting including topics with major public health interest (e.g. start and finalization of safety review referrals)

• PRAC minutes are published in full (with the exceptions listed above) on the EMA website after their adoption at the end of the following scientific meeting.



Section 3 – The Dutch Freedom of Information Act (WOB)

The Dutch FOIA (WOB)

• The Dutch FOIA has a focus on information, rather than on documents (contrary to the Transparency Regulation),

• 'document' should be interpreted widely

Absolute exceptions:

• The documents will not be provided for as far this:

- Concerns company and manufacturing information, which have been communicated to the government in a confidential fashion by natural persons or legal entities; Article 10(1)(c) FOIA

- ABRvS 2-4-1998, JB 1998/77, Bristol-Myers Squibb

- ABRvS 18-12-2002, JGR 2003/1, GlaxoSmithKline

- Personal data of individuals that enjoy data protection

These grounds fall under the scope of the so-called absolute grounds for refusal

However, in case law a restrictive interpretation is given to company and manufacturing information



FOIA (continued)

Relative exceptions:

• The documents will not be provided on balance with:

- harm the relationship with other countries

- ABRvS 17-2-2010, ECLI:NL:RVS:2010:BL4132, Iraq war

- interests of government inspection and supervision

- privacy of individuals

- disproportionate damage or advantage of interested parties



Section - 4 Case law

AbbVie v. EMA T-44/13 R, 25 April 2013, General Court

• Decision of the EMA granting third party access under Reg 1049/2001 to three clinical study reports submitted by Abbott (legal predecessor of AbbVie)

• Part of its MA application for Humira used to treat Crohn's disease

• Pursuant to 4(4) Reg, EMA notified applicants of receipt of such request

• AbbVie opposed disclosure – disputed reports are covered by exceptions provided for in Article 4(2) Reg

• EMA granted access

• AbbVie sought an interim relief order



AbbVie v. EMA T-44/13 R, 25 April 2013, General Court

• "The legal situation created by interim proceedings must be reversible, it must be recalled that the purpose of the procedure for interim relief is merely to guarantee the full effectiveness of the future decision on the main action" (point 40)

• AbbVie: disclosure before end of main proceedings would deprive us of the right to effective remedy

• Disclosure under Reg 1049/2001 has erga omnes effect

• EMA states that decision was solely based on new policy since 2010

• Besides, there is no case law on question whether contested decision, based on new policy, infringes applicants right to professional secrecy, as guaranteed by Article 339 TFEU, 8 ECHR and 7 of the Charter, ie. the disputed reports are confidential in nature.

• Such question cannot be ruled on for the first time by a judge hearing an application for interim measures

• The operation of the contested decision is suspended; EMA is ordered not to disclose

• Appeal case in progress with Court of Justice (C-389/13)



Council of State of the Netherlands JB 2012/280 Strattera, 7 November 2012

• Dispute concerns the refusal of the Dutch MEB to disclose the Risk Benefit Assessment of the British MHRA pertaining to ADHD drug Strattera by Eli Lilly

• Case reports contain personal data on patients, including medical history

• All data that could lead to identification of individual patients within the small adverse events group are confidential

• Personal data of external experts are confidential, interest of protection against animal rights activists

• Content of expert opinions is not confidential

• Published info is not confidential



Conclusion

Pharmacovigilance & transparency

• Law is under development: both on pharmacovigilance and on transparency

• Case law concerning transparency will develop further and may more and more focus on pharmacovigilance data since it provides information on the safety of medicinal products

• More information will become transparent, also in terms of registers (reasons for withdrawal/ cessation of marketing of medicinal products; which medicinal products are under additional monitoring)

• Currently, the outcome of the EMA/ AbbVie appeal case is to be awaited

• Product liability cases may increase as evidence may be better available due to the new rules



Wouter Pors

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