Pharmaceutical Executive Europe - May 2008 - (Page 12)

12 European Union May 2008 Pharmaceutical Executive Europe Rising in the East Dr Ina Ruehl-Bagheri assesses the impact of two new EU clinical trial Directives on Poland, Hungary and Latvia. linical trials conducted in all countries in Central and Eastern Europe (CEE) have been carried out according to Good Clinical Practice (GCP) standards since the late 1980s. Over the past 5–7 years, some CEE countries have presented excellent opportunities to the pharmaceutical and clinical research organisation (CRO) industries for conducting clinical trials in terms of data quality, patient recruitment rates and competitive start-up timelines. Countries such as Poland, Hungary and Latvia, have adapted their regulatory requirements and proven that they can consistently deliver high-quality data. Together with Czech Republic, Slovakia, Lithuania and Estonia, they are pioneers compared to other countries in the region, thanks to their adoption of ICH-GCP compliant legislation and the availability of ICH-educated investigators and well-developed medical and pharmaceutical services. Compared with some western European countries and the USA, they provide the advantages of improved recruitment and retention rates, unsaturated markets, a high level of qualified and motivated investigators and lower costs. These competitive advantages mean that CEE is increasingly becoming the region of choice for conducting clinical trials. Since many CEE countries became members of the EU in 2004, national regulations have been amended to incorporate EU legislation. Two EU Directives in particular have had an important effect on the approval process for clinical trials. EU Directive 2001/20/EC was introduced to accelerate and standardise the process for obtaining authorisation to conduct clinical trials in all the member states (including the acceding countries). Pursuant to the Directive’s regulation, pharmaceutical companies and CROs are required to obtain authorisation for a clinical trial from the relevant body of a member state within a maximum of 60 days from the date of receipt of a valid application. The second key EU Directive, 2005/28/EC, came into force on 29 January 2006. The purpose of this is to harmonise standards with regard to GCP and the conduct of clinical trials in individual countries. So, what impact are these Directives having in the blossoming CEE region? C the availability of highly qualified investigators, an existing network of specialist clinics and teaching hospitals, a large potential patient population and relatively low costs. Since joining the EU, the regulations governing the conduct of clinical trials have changed and not all the changes have been favourable. One such change is that the time needed to obtain authorisation has been significantly increased, due to the excessive requirements of the authorities responsible for approval. This increased bureaucracy is a potential barrier to the development of the clinical trials market in Poland that could hinder the influx of modern medical knowledge and investment in the pharmaceutical industry. In areas where there are effective regulations based on the EU Directive, such as the implicit authorisation included in Polish pharmaceutical law, difficulties have arisen in the way that the law is interpreted by the authority responsible for clinical trial approval. The need to improve the current legislation and bring it into line with the EU Directive 2005/28/EC has been recognised by parliament. The Ministry of Health is preparing legislation on clinical trials, which will make the process of conducting trials in Poland more transparent. Despite the increase approval time since EU accession, the number of trials registered in Poland has continued to grow and is currently approximately 400 per year. This has been helped by the fact that, with a population of approximately 40 million, Poland is the second most populous country in CEE and provides a large potential population base for trial recruitment. In addition, Polish patients may be more willing to participate in clinical trials than patients in western Europe because of the lack of sufficient preventive medicine and lack of access to newer treatments in the country. Another important factor is the patient recruitment rate, which is usually higher in Poland than other recruiting countries. Poland thus remains an important country for pharmaceutical companies and CROs. Hungary With a total population of 10 million, Hungary is a medium-sized country within the EU. The first legislation governing the conduct of clinical trials was introduced in 1987 and since then the number and types of clinical trials conducted in the country have grown rapidly. Prior to accession, Hungary implemented EU Directive 2001/20/EC into national legislation in the form of Ministerial Decrees 23/2002 Stockbyte/Getty Images Poland Poland already had a good reputation for conducting high-quality clinical trials prior to EU accession. Factors contributing to this were http://europa.eu/eur-lex/pri/en/oj/dat/2001/l_121/l_12120010501en00340044.pdf http://europa.eu/eur-lex/pri/en/oj/dat/2001/l_121/l_12120010501en00340044.pdf http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2005/l_091/l_09120050409en00130019.pdf

Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - May 2008

Pharmaceutical Executive Europe - May 2008
Contents
From the Editor
News and Analysis
Calendar
Rising in the East
Use Your Strategic Discretion
A Blueprint for Success
Market Access and the Patient
Activating Effective Product Differentiation
What Doctors Want
IC Success in Four Steps

Pharmaceutical Executive Europe - May 2008

http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201302
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201301
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201212
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201211
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201210
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201209
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201208
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201207
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201206
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201205
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201204
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201203
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201202
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201201
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201112
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201111
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201110
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_201109
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110823
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110809
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110728_v2
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110728
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110711
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110624
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110609
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110526
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110512
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_oracle_201105
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110426
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110412
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110324
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110310
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110224
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110208
http://digital.findpharma.com/nxtbooks/advanstaruk/pegd_20110128
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_mediakit2011
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20101216
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20101124
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20101111
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20101027
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20101013
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100930
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100915_supp
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100915
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100825
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100811
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100727
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100713
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100623
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100609
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100526
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100512
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_ims_201005
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100427
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100414
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100324
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100310
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100224
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100210
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100126
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100112
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20091222
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20091208
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20091124
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20091110
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20091027
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20091013
http://digital.findpharma.com/nxtbooks/advanstaruk/PEE_DIGEST_20090930
http://digital.findpharma.com/nxtbooks/advanstaruk/PEE_digest_20090916
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090902
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090825
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090819
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090812
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090805
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090729
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090721
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090715
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090708
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090701
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090624
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090617
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090610
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090602
http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20090526
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090519
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090512
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090505
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_southafrica
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090429
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090422
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090415
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090408
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090401_v2
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090401
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090325
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090318
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090311
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090304
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090224
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090218
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090211
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090203
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090128
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090121
https://www.nxtbook.com/nxtbooks/advanstaruk/pee_digest_20090114
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope1208
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope1108
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope1008
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope-ims1008
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0908
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0808
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0708
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0608
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope-imssales0508
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0508
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0408
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0308
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0208
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope-imssales0208
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0108
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope-ims1207
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope1107
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope1007
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope-imsoncology0907
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0407
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope0307
https://www.nxtbook.com/nxtbooks/advanstaruk/pharmexeceurope1206
https://www.nxtbookmedia.com