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

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

Pharmaceutical Executive Europe - May 2008
From the Editor
News and Analysis
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