July 8 2013 | By Márcio Barra
It’s no secret that clinical research in Portugal has, from year to year, been losing clinical trials to other countries. As seen on Pharmupdates original article “The current state of Clinical trials in Portugal”, the reasons to blame are many, and this lack of investment is hurting the country.
PwC, in Partnership with Apifarma has developed an in depth report entitled “Ensaios Clínicos em Portugal”, launched this past June and received with quite a lot of expectations here at Pharmupdates, as it sheds more light in this matter. This report (in Portuguese) details the clinical trial activity in Portugal to try and understand its importance in the Portuguese economy, identify the main barriers to their progress and outline a set of proposals to overcome the identified limitations.
The methodology of the study included:
- Research in databases;
- Interviews with 20 personalities of the clinical trial sector in Portugal;
- Realization of a questionnaire to 24 companies, of which 19 responded: 15 pharmaceutical companies and 4 CROs;
- Collecting information from the National Competent Authorities of six reference countries;
- Adaptation of the Input-Output Matrix for Economy in order to simulate the clinical trials industry and conduct an impact analysis.
The study comes in a critical time for the clinical trial industry in Portugal. The transposition of the current European Directive for clinical trials was already recognized as one of the main factors of loss of efficiency in the European Union and inequality between Member States. The upcoming review of Community legislative framework presents a window of opportunity for Portugal to revamp its clinical trial structure, and communication between all stakeholders is absolutely necessary in the coming times.
PwC managed to identify in the report the main barriers and challenges, which were structured into five main categories in the report: Politics and Strategy, Policy and Legislation, Organization and Infrastructure, Incentives and Training and last, Technology and information.
A disorganized sector
The number of ongoing clinical trials in Portugal between 2006 and 2012 decreased 26%, from 160 to 118 studies, with the lowest number of clinical trials ever submitted in Portugal being 2011, with only 88 studies. The rate of clinical trials per million inhabitants in Portugal is among the lowest in Western Europe. Phase 3 and 4 trials make up 80% of all trials, with phase 3 trials alone being responsible for 68% of trials approved in 2012. As for the phase 1 trials, these have almost no representation, with only 8 approved over the last 4 years. It is also troubling to see that the three companies with the greater number of trials are responsible for nearly half (41%) of all trials conducted in Portugal.
Clinical trials by initiative of investigators are also few and far between, especially when compared with Spain and the UK, countries where academic clinical trials represent about a quarter of the total authorized trials in a year. Absence of legislation that regulates and promotes academic research is hurting this sector in Portugal.
When evaluating the process of new trial approval, Portugal pales in comparison against other European countries. The average approval time of a clinical trial exceed 70 days. This average does not include approval by the institution where the trial is to be conducted, which can take several months. Thus the real-time approval of a clinical trial often exceeds 6 months in Portugal says the report. Inefficiency and uncertainty clarification requests, absence of legal deadlines for approval of the financial contract, and a mandatory approval by the National Committee for Data Protection without legally stipulated deadlines (something that is not mandatory in other Member States) certainly don’t help Portugal make a compelling case.
Patient recruitment is pointed as another big factor. With the exception of the year 2011, the number of new patients enrolled in clinical trials has been declining. The study “Clinical Trials in Portugal (Investment Potential)”, by APIFARMA concluded that, from 2007 to 2011, Portugal was able to recruit only 70% of the initially planned patients. This means that about 1/3 the potential investment is lost due to inadequate recruitment. The small number of patients included in trials in Portugal is mostly due to the reduced number of centers participating in each trial, the general perception of the public that clinical research is akin to guinea pigs, and lack of legal framework for promoting clinical trials to the patients.
Despite all these shortcomings, this activity is still highly profitable for Portugal. The 370 active clinical in trials in 2012 represented a market value of 35 million euros, and 7.5 million in tax revenue. Clinical trials also saved 3.5 million euros in expenses in medicines for the Portuguese Government. The clinical trial activity was responsible for a Gross Value Added of 72 million euros in 2012. For each euro that is invested in clinical research, it is estimated that there is a return of 1.98 euros for the Portuguese economy. This makes clinical research one of the activities with the highest return on investment in the country. Thus, in the middle of austerity, this activity should be higher on the priorities of the country.
The absence of a strategic vision for the activity of clinical trials, a legislative and regulatory framework that is inefficient and the inadequacy of available infrastructures to the needs of the clinical trial activity, has led Portugal to lose competitiveness in this sector, particularly when compared with some emerging countries. Also, if you have been following the news in Portugal (through Pharmupdates maybe) the successive drug price cuts naturally constitute a factor which discourages investment for research and commercialization of new medicines in Portugal.
The identification of initiatives implemented in other reference countries allowed the elaboration of a set of proposals by PWC and APIFARMA for Portugal. The measures proposed are extensive. Here are some of the ones presented:
- Definition of a government agenda and strategic plan for the clinical research sector, including outlining the clinical research centers network and creation of an evaluation model for clinical research conducted in health care centers;
- Review of legislation to promote academic research;
- Creation of management structures dedicated to clinical research, like nonprofit academic CROs to support academic research;
- Creation of the necessary conditions for conducting clinical trials in Health Centers;
- Review of the tax incentives scheme;
- Review of current legislation on the approval process for clinical trials, including shortening up the approval time from 60 days to 30 days. For phase 1 trials a shorter deadline can be mandated;
- Creation of specific legislation for promotion of clinical trials to patients;
- Promotion of an effective central hub for clinical research;
- Development of patient recruitment systems;
- As for the National Ethic Committee (CEIC), the report suggests the elimination of the need for review of a uniform financial contract by the CEIC. Also, if the CEIC gives a positive opinion regarding a trial, the opinion of the Ethics Committees of each clinical trial center should be made redundant.
- Review of the National Committee for Data Protection’s role.
- Review of the research component in the career and work schedule.
- The implementation of the proposed measures may cause a 71 million growth of the Gross value added generated by clinical trials, potentially doubling by 2015 the Gross value added of the clinical trial activity in Portugal.
Now the question is, will the Government heed in these recommendations and step in with a solid plan for clinical research in Portugal in order to attract more investment? Hopefully it will.