November 11, Ignacio Garcia Bercero Director DG Trade B-1049 Brussels BELGIUM

Transcription

1 Nvember 11, 2013 Ignaci Garcia Bercer Directr DG Trade B-1049 Brussels BELGIUM Daniel Mullaney Assistant USTR fr Eurpe and the Middle East United States Trade Representative Washingtn, DC USA Dear Mr Bercer and Mr Mullaney: On behalf f the Trans-Atlantic Business Cuncil (TABC), we wuld like t express ur strng supprt f the life sciences industry fr the current negtiatins fr a cmprehensive and ambitius Trade and Investment Partnership (TTIP) between the US and the EU. The TABC includes as members innvative cmpanies in the life sciences sectrs, ntably pharmaceuticals, bipharmaceuticals, medical devices, and ver-the-cunter medicines. Our sectrs represent a significant share f trade and innvatin n bth sides f the Atlantic, accunting fr mre than 80% f glbal sales f new medicines and 75% f glbal R&D in life sciences. At the same time, differences in apprval standards and the lack cmpatibility f prcesses and standards create unnecessary barriers t further develpment. It is ur hpe that a rbust and enfrceable agreement that tackles these barriers will drive prgress in the glbal race fr R&D, and supprt innvatin, jb grwth and the develpment f innvative prducts t imprve health. It wuld als enhance alignment in brader engagement with third cuntries. In rder t achieve this, US and EU plicymakers, negtiatrs and regulatrs shuld wrk tgether t encurage pen market access, greater regulatry cmpatibility, investment, as well as strengthened intellectual prperty rights, and the remval f tariffs. Regulatry issues: An enhanced EU-US relatinship culd represent a unique pprtunity t seek even greater cmpatibility and t create streamlined prcesses and prcedures between the EU and the US. T this end, specific regulatry cmpatibility prpsals are as fllws: Increase effrts t c-rdinate and avid unnecessary duplicatin between the FDA and EMA, ntably by each side mutually recgnizing manufacturing site (GMP) inspectins, as well as parallel scientific advice. The latter shuld expand t be 1

2 applicable t all medicines, and grant spnsrs the right t receive it upn request. Mre cnsistent regulatry requirements fr trial data fr apprval f medicines. Strengthen EU-US cllabratin within the ICH framewrk in a number f areas, including: greater cmpatibility in scpe, cntent and timing f submissin f paediatric plans, requiring nly a single plan fr submissin in bth territries, and effrts t harmnize bth the structural framewrk and methdlgy fr benefit-risk assessments, and n appraches t pst-apprval variatin submissins fr manufacturing changes. Establish a prcedure fr cllabrative develpment f scientific and ther regulatry guidelines fr specific therapeutic areas. Harmnize practices by EMA and FDA n the clearance and acceptance f drug names. One cmmn brand (where legally apprpriate) will als facilitate PV surveillance and thus cntribute t patients safety. Regarding Over-the-Cunter (OTC) medicines, greater recgnitin f Rx-t-OTC switch by the EMA and FDA in each ther s market, and greater acceptability f freign trial data by the EMA and FDA in supprt f a Rx-t-OTC switch. Particularly due t the fact that a Rx-t-OTC switch in the US means the prduct is available utside the pharmacy, these data shuld be cnsidered strng evidence f ptential safe OTC use in EU. Cnsider allwing pen access t ver-the-cunter medicines, and allwing the placement f them in frnt f the cunter at pharmacies. Implement cmmn EMA and FDA practices n the clearance and acceptance f medicine names. Wrk cllabratively t eliminate cunterfeit and substandard medicines. Harmnize appraches and plicies regarding verificatin f prescriptin medicines (e.g. serializatin) in the EU and the US. In rder t prtect patient safety, pharmaceutical prducts shuld have unique identifier t allw them t be recgnized by the manufacturer, whlesaler and pharmacy. Unique prduct identifier will enable custms t identify prducts internally. Custms shuld include (high risk) prducts in the Wrld Custms Organizatin (WCO) database t be entered fllwing WCO s Interface Public-Members (IPM) rules. Apart frm harmnizing regulatins, cntinue and increase the exchange f persnnel between the respective medicines agencies culd als help supprt this bjective. Sharing f clinical trial data infrmatin and public disclsure f data cntained in marketing authrizatin dssiers fr medical prducts by the cmpetent regulatry authrity: In light f increasing data disclsure requirements, the EU and the US shuld be willing t adpt an aligned, respnsible and balanced apprach t data sharing, which prtects bth patients and cmpanies interests while fstering innvatin. The TTIP shuld therefre ensure that bth the EU and the US maintain unifrm prtectin f patient privacy, regulatry prcess integrity and cmmercial interests in their respective clinical trial data and marketing authrizatin applicatin disclsure prgrams. Market Access: The life sciences sectrs face unique market access challenges. This is due t strict regulatry apprval standards, as well the dependence n btaining psitive pricing and reimbursement (P&R) decisins frm gvernments and ther authrities. 2

3 Fllwing precedents set with the KORUS and EU-Krea FTAs, TABC urges the adptin f a Pharmaceutical Annex that wuld respnd t these challenges, ntably by emphasizing that prcedures and all P&R decisins must be gverned by transparent, verifiable and enfrceable rules, shuld adequately recgnize the value f the prduct, and reward innvatin. Recgnitin that Internatinal Reference Pricing (IRP) shuld nly be applied between cuntries with similar sci-ecnmic levels, ppulatins, disease burdens and health care systems; furthermre, there shuld never be reference t cuntries subject t ecnmic crisis measures (e.g. IMF interventin) r mandating measures such as price cuts. T apprpriately recgnize innvatin, the gvernment price fr an innvative prduct shuld never be set by reference t prices fr generic prducts. Health Technlgy Assessment (HTA): Safeguarding the independence f HTA bdies and the invlvement f all interested parties, and ensure that HTA is cnducted in an bjective, fair and transparent manner, with effective means t challenge decisins and adequate remedies available t all interested parties. Patient Access: The time limits fr pricing and reimbursement decisins f 180 days established by EU Directive 89/105/EEC are significantly exceeded by several member states. Time t market access measures shuld be adhered t. Any clawback r rebate tax levied by a Party in respnse t an ecnmic crisis shuld nt disprprtinately burden innvative pharmaceutical manufacturers (i.e., any tax shuld be brne by the entire supply chain), and shuld be subject t a transparent, annual review prcess that affrds thse subject t the tax the pprtunity t cmment n whether it remains necessary t cntinue the tax. Revenues raised by such taxes shuld be earmarked t cver healthcare expenditures. Intellectual Prperty Rights (IPRs): IPR is a fundamental element f the life sciences sectr. Effective prtectin and enfrcement are essential fr the cntinued investment fr the develpment f innvative pharmaceuticals. The TABC calls fr mves t imprve upn existing legal standards and further, t harmnize and strengthen prtectin. The EU and US shuld: Seek t harmnize and align intellectual prperty prtectin and enfrcement measures in the life sciences sectr, e.g. by increasing Data Exclusivity (DE) fr bilgics in the EU t 12 years, and t 10+1 years data exclusivity fr small mlecules in the US. Harmnize apprach t patent term adjustment if patent examinatin was delayed by the patent ffice. Ensure sufficient IP incentives fr the develpment f pediatric medicines, rphan medicines, Rx-t-OTC switches (3 year data prtectin) and ther specific needs. Prvide fr enfrcement mechanisms t prevent patent-infringing prducts frm entering a market while a patent-infringement dispute is nging. 3

4 Avid impsing restrictins n the use f trademarks by a) nt requiring that nly generic names be listed n the packaging f a pharmaceutical; and b) ensure that, n such material, generic names are nt given mre prminence than prprietary drug names r that use f generic names in prescriptins is given preference ver the use f the prprietary drug names. Avid interference with markets stemming frm rules and prvisins in EU (and EU member states ) law giving privilege r even exclusivity t generic names ver prprietary names. Allw fr greater flexibility in umbrella branding i.e. multi APIs under a single brand. Expand current cmmitments t align US and EU psitins in multilateral dialgues, t encurage rbust third cuntry prtectin f intellectual prperty (e.g. establish standard fr wrking interpretatin f article 39 TRIPS - what is wrking and what are wrking requirements, clarify that cmpulsry licensing shuld nly be allwed under very tight restrictins). The EU and US already cllabrate twards this bjective in cmmitments made in the Transatlantic IPR Wrking Grup s Actin Strategy and in the Transatlantic Ecnmic Cuncil. These cmmitments culd be further blstered by the inclusin f similar mechanisms in a transatlantic agreement. Medical Devices: A standstill n any new buy-natinal requirements shuld be agreed at the utset f the negtiatins and the applicatin f exprt cntrls t medical devices shuld be clarified t (1) mre clsely reflect the aims and plicy f the Wassenaar Agreement; (2) avid unnecessary cmplexity f classificatin f gds fr medical and humanitarian use; and (3) prvide cnsistency f treatment f medical devices, equipment and related sftware and accessries acrss the EU and between the EU and US. TABC supprts the fllwing jint pririties fr the TTIP put frward by the Eurpean and American industry assciatins fr medical technlgy: 1) maintain harmnizatin between ISO and FDA's Quality System Regulatin (QSR), 2) a single audit prcess, 3) harmnized frmat fr prduct registratin submissin, and 4) a cmmn way t trace prducts thrugh a single unique device identificatin (UDI) prcess with interperable databases. TABC supprts the develpment f regulatry guidance n mbile medical apps. Guidance shuld be develped analgus t the FDA s Final Guidance n Mbile Medical Applicatins. The small subset f regulated mbile medical apps shuld be distinguished frm nn-medical mbile apps which by definitin are nt regulated medical devices. Thse include cmmn and general health apps that may be used in a healthcare envirnment, in clinical care r patient management, but are nt cnsidered medical devices as they d nt present the ptential fr patient harm. In additin, clarity shuld be prvided fr mbile apps that may be cnsidered mbile medical devices but are f such a lw-risk t patient harm that enfrcement f regulatins wuld be impractical. Guidance shuld als prvide backgrund, regulatry requirements and infrmatin n additinal resurces t help stakehlders in an n-ging fashin. 4

5 Tariffs: Althugh mst finished pharmaceutical prducts are imprted duty-free under the Pharmaceutical Appendix t the Harmnized Tariff Cde in the US, the prcess fr adding additinal items t the Appendix is time-cnsuming and uncertain. Tariff cdes are nt sufficiently harmnized between the US and the EU, and thus there are ptential cnflicts in classifying gds traded between the tw. It is nt pssible t determine an average tariff n exprts/imprts due t the vlume and cmplexity f the items imprted. In additin, research and develpment cmpunds are generally subject t duties. This can influence the decisin whether t imprt int the US r perfrm research r develpment activities elsewhere. Eliminate tariffs relating t the shipment f research tls and equipment between trade partners. Reduce pssible tariffs that apply t purchased gds. TABC stands ready t supprt yu and yur teams t advance discussin in this imprtant sectr fr the transatlantic ecnmy and we lk frward t wrking with yu as TTIP negtiatins mve frward. With kind regards, Tim Bennett Directr General Trans-Atlantic Business Cuncil 5