Ref. Ares(2016)6036878 - 20/10/2016
TTIP & HEALTH BEUC position
Contact: Ilaria Passarani – Katrina Perehudoff
Ref.: BEUC-X-2015-064 - 23/06/2015
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Pharmaceuticals and medical devices have been flagged as key areas that will be
covered by the Trans-Atlantic Trade and Investment Partnership (TTIP)
agreement. TTIP is expected to facilitate trade and investment by eliminating
barriers posed by regulation and other rules. What would this mean for the
health sector in Europe? Enhancing consumer safety should be the number one
goal of regulatory cooperation in the health sector. To this end, BEUC welcomes
the potential for:
Mutual recognition of inspections of manufacturing plants based on
principles and guidelines defined as “Good Manufacturing Practices” to
achieve more effective use of resources;
Reducing needless duplication of clinical trials to avoid exposing
consumers to unnecessary risks;
Upwards harmonisation of the technical requirements for the
authorization of medicines and in particular for paediatric medicines,
generics and biosimilars to improve patient safety and access to
Convergence of systems for identifying medical devices (UDI) to improve
To achieve these advances for consumers, past experience has shown that an
all-encompassing agreement such as TTIP does not seem to be essential to
promote regulatory cooperation. Moreover, attention must be paid to the
following, potentially overshadowing, issues:
EU governments should maintain full autonomy to make pricing and
reimbursement decisions about pharmaceuticals and medical devices in
the public interest;
The EU recent progress on clinical trials transparency and the EU Clinical
Trials Regulation should not be undermined by references to trade
secrets and commercial confidentiality;
TTIP should not lead to any extension of intellectual property rights and
exclusivities applied to medicines in the EU.
Pharmaceuticals and medical devices have been flagged as key areas covered by
the Trans-Atlantic Trade and Investment Partnership (TTIP) agreement. TTIP is
expected to facilitate trade and investment by eliminating barriers posed by
regulation and other rules. What would this mean for the health sector in
Europe? The European Consumer Organisation sees both potential benefits and
risks for consumers in the TTIP deal.
Although this position paper focuses on the impact of TTIP on pharmaceuticals
and medical devices in the EU, there are two overarching challenges that must
be addressed if TTIP is to be beneficial to consumers. First, BEUC welcomes the
recent transparency initiatives of the Commission that increased access to
negotiating texts and information regarding the TTIP negotiations. BEUC calls for
greater efforts in order to have public access to consolidated texts. Second, the
Investor-to-State Dispute Settlement (ISDS) mechanism would allow foreign
companies to sue a state that allegedly does not respect the provisions of the
agreement under a supra-national arbitration system. ISDS has been used in
Australia and Canada to sue governments taking public protection measures,
such as introducing plain packaging for tobacco products or setting high
standards for pharmaceutical patents. BEUC believes the ISDS mechanism is too
flawed to be fixed and advises negotiators to find other means to protect foreign
investments. Read BEUC’s position paper.
2. Existing regulatory cooperation without TTIP
It is noteworthy that in many aspects of pharmaceutical regulation and
investment, the EU and the USA are already engaged in global or bilateral
cooperation. The Transatlantic Administrative Simplification Action Plan1 signed
in 2007, aims to remove administrative burdens to the interaction between EMA
and FDA. These Agencies share information on market authorisation procedures,
changes to market authorisations and post-authorisation surveillance for
products under review both in the USA and in the EU, through:
- The exchange of assessment reports and review documents;
- Regular videoconferences on specific topics and classes of medicines,
such as oncology, orphan medicines, paediatrics, vaccines, blood
products, pharmacogenomics, advanced therapies, veterinary medicines
and biosimilar medicines;
- Ad hoc teleconferences between USA and EU experts.
The two Agencies have developed common procedures for Good Manufacturing
Practice2 and Good Clinical Practice inspections and for applications for orphan
designation. They also share information on pharmacovigilance, scientific advice,
biomarkers, inspection planning and reporting and preparedness for pandemic
Moreover, the confidentiality agreements between the EU and the FDA
were extended in 2005 and again in 2010. They are now effective for an
indefinite period without the need for further renewal.
Therefore, an all-encompassing agreement such as TTIP does not seem to be
essential to promote regulatory cooperation.
3. Mutual recognition of Good Manufacturing Practices can
enhance efficiency and safety
Currently, European and American authorities conduct inspections of companies’
facilities on their territories and third countries to check compliance with good
manufacturing practices (GMP) and verify the quality of products. Closer
cooperation between EMA and FDA could avoid duplicating such inspections,
thereby more effectively using resources.
EMA does not currently have an operational Mutual Recognition Agreement with
the USA for Good Manufacturing Practices. However, Mutual Recognition
Agreements do not require a partnership such as TTIP, as the EMA already
maintains agreements with Australia, Canada, Israel, Japan, New Zealand and
The formal recognition of manufacturers quality management system audits
(QMS) could also reduce costs for inspections for medical devices. However, the
EU and the US are already working together in the international initiative
'Medical Device Single Audit Programme - MDSAP' and developed the concept of
“single audit” by which, when auditing a facility, QMS auditors check compliance
with the requirements of several jurisdictions at the same time.
4. Harmonised requirements for the authorization of
medicines can reduce needless duplication of clinical trials
and facilitate access to medicines
The upwards harmonisation of the technical requirements to demonstrate
quality, safety and efficacy of medicines can facilitate the recognition of clinical
trials on both sides of the Atlantic, saving resources and sparing more patients
from the risky process of experimenting with medicines. This is particularly
important especially with regard to medicines for children. In this respect BEUC
would support the revision of the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use
(ICH) guidelines on paediatrics as, at the moment, there are some differences in
the conduct of paediatrics trials that make it difficult to compare data and
mutually accept studies. BEUC also supports the convergence of the systems for
the authorization of biosimilars and generics.
5. Medicines and medical devices pricing & reimbursement
have no place in an EU-US trade deal
EU governments should maintain full autonomy to make pricing and
reimbursement decisions about pharmaceuticals and medical devices in the
public interest. BEUC welcomes the EU commitment indicating that “neither TTIP
nor any other EU trade deal would affect EU governments' right to decide how
much people have to pay or how they're reimbursed”. However further
clarification is needed with regard to the reference to the transparency of
decision making4. While we support the principle that regulatory decisions
should be made in a “clear and open way”7, we oppose the inclusion of an Annex
on transparency and procedural fairness provisions similar to those introduced in
the Korea-US5 and Australia-US agreements.
BEUC supports balanced stakeholder involvement in decision making at all
levels. At the same time, BEUC finds that local, national and European fora are
better suited to such exchanges that impact on European consumer protection,
rather than an EU-US trade partnership. Expanding the role of stakeholders
through the mandatory exchange of information can increase the pressure on
decision makers, particularly from foreign investors. Indeed, corporate pressure
has played an influential role in past decisions to reimburse unproven medicines
at the cost of consumers and EU health systems6.
6. Safeguard progress on access to clinical trials data
The newly adopted European Regulation on clinical trials (n. 536/2014) and the
new EMA policy on publication and access to clinical trials data7 put Europe at
the fore front with regard to regulatory transparency and accountability.
European consumers expect that the EU’s high standards for clinical data
disclosure are upheld by TTIP. In this context BEUC welcomes the EU
commitment7 not to negotiate - neither in TTIP nor in other EU trade deals – any
rules that will impact “in any way” the EU Regulation on clinical trials.
With regard to the exchange of information about the safety, efficacy and quality
of medicines between EMA and FDA, BEUC supports the highest possible level of
information sharing and the narrowest definition of commercial confidentiality
and trade secrets. According to EU law, any information received or held by the
EMA will be subject to European legislation on Access to Documents (Regulation
n. 1049/2001) and Data Protection (Directive n. 95/46/EC).
5 Final Text of the Pharmaceuticals and Medical Devices chapter in the KORUS FTA
6 Van Herck, P., Annemans, L., Sermeus, W., & Ramaekers, D. (2013). Evidence-based health care
policy in reimbursement decisions: lessons from a series of six equivocal case-studies. PloS one
7. No extension of the intellectual property protection that
keeps medicines prices high
The EU already has 20 years of patent protection and a number of other
exclusivities granted to certain medicinal products. In general, longer patent
protection or exclusivity delays competition from generics and keeps medicines
prices high, at the expense of the healthcare system and, ultimately, the
TTIP should not lead to any extension of the intellectual property rights and
exclusivities already applied in the EU. BEUC notes that existing EU laws,
notably the Bolar exemption in Directive 2004/27/EC8, must be respected by
TTIP. Concerning intellectual property protection, BEUC welcomes the EU’s
commitment “not to negotiate anything in TTIP which would … increase costs for
EU countries’ national health systems, which are already stretched”9 .
8. No US-style medicines promotion
The EU and the USA take different approaches to the promotion of
pharmaceuticals. Given TTIP’s ambitions to enhance regulatory cooperation, it
must be said that TTIP needs to be in line with Directive 2001/83/EC on
medicinal products for human use, which prohibits advertising of prescription
medicines and governs the acceptable role of industry in information production
and dissemination to patients10.
9. Safer medical devices
BEUC supports the main elements of possible cooperation in the medical devices
sector as outlined in the EU position on medical devices in TTIP11, including the
recognition of manufacturers quality management system (QMS) audits ( see
also point 3), convergence of system for identifying and tracing medical devices
(Unique Device Identification – UDI) and of models form marketing submission
(Regulated Product submission). However we regret that the harmonisation of
the approval system of devices in the EU and the USA is ruled out. European
consumers are often considered as ‘guinea pigs’ for medical devices, especially
in comparison to consumers in the United States12. Many products used in
Europe were never approved in the USA as they were considered dangerous and
ineffective13. While in the USA high risk devices are subject to a form of
marketing authorisation and are assessed by the Food and Drug Administration
on the basis of valid clinical evidence to prove their safety and effectiveness, in
Europe they can enter the market after a CE certification by private companies
8 Directive 2004/27/EC Article 10(6).
10 Directive 2001/83/EC Articles 86-90.
12 It is worth noting that only one in five of the 8.500 medical devices companies in Europe have
approached the USA market. In addition, more devices of a particular type are often marketed in
Europe compared to the US, e.g. 28 drug eluting stents are CE marketed while only five obtained
13 Unsafe and ineffective devices approved in the EU that were not approved in the US, Food and
Drug Administration, May 2012.
called “notified bodies” on the basis of limited evidence and often without
significant studies in humans14,15.
European consumers should not be involuntarily partaking in what is effectively
a large, uncontrolled experiment16. The current system is unethical and exposes
consumers to unjustified risks. BEUC considers TTIP as a useful opportunity for
an upward harmonisation of safety requirements for medical devices in Europe.
When finalising the long awaited Regulation on medical devices that has been
pending since 2012, EU legislators should ensure European consumers are
granted the same level of protection as their American counterparts.
10. Health services should be excluded from TTIP
According to Article 168 of the Treaty the management, organisation and
delivery of health care is a sole responsibility of Member States and it should
remain as such. On several occasions EU negotiators17 confirmed that health
services will be exempt from TTIP. Rather than an exemption BEUC calls for a
hard exclusion or a “carve out” of health services from the scope of application
14 D. Kramer et. Al, Regulation of Medical devices in the United States and European Union, New
England Journal of Medicine, March 2012.
15 D. Zuckerman et al., Public health implications of differences in USA and European Union
regulatory policies for breast implants, Reproductive Health Matters, 2012.
16 Dispositifs médicaux: le patient sert de cobaye, Test-Achats, Test-Santé n. 106, Décembre 2011.