Emerging Markets
Start-up can be very lengthy (see Table 4) and
Box 1: Recent regulatory changes in
the process generally involves three phases:
Latin America
Table 4: Total start-up times in
regulatory review, contracts being signed by
Latin America
Argentina
sponsors and investigators, and the logistics of
getting everything into the country, says
Country Start-up time (months)
In November 2007 Argentina published a
resolution which brought GCP guidelines in line
Dr Hurley. Brazil provides an interesting case
Argentina 6
with the Document of the Americas.
study on this point. Despite the country’s size
Brazil
and potential to enrol large numbers of patients,
Brazil 9
National Ethics Committee review and Competent
Brazil has not received its fair share of trials, he
Chile 5
Authority reviews for approval now take place in
adds. This is largely because it is still the slowest
parallel. This change could potentially reduce country in the region in start-up terms, despite Colombia 4
approval times from 10 months to 8.5 months. shaving six weeks off the process through recent
Mexico regulatory changes (see Box 1). “No one wants
Mexico 3-4
Customs authorities have removed the to wait that long to get started, unless the trial
Peru 5.5
requirement for import licences for drugs or for has a long enrolment time,” Dr Hurley
Source: Dr Dennis Hurley, vice-president of Kendle’s
export licences on blood serum samples. This has
comments.
Latin American operations
reduced the start-up timeline from 3.5-4.5 months
However, as Latin America’s various regulators
to 3-4 months, bringing Mexico’s figures in line
begin to address this issue (see Box 1), another
with EU countries.
with the site’s informed consent process or
bottleneck is already emerging – the issue of
Chile
GCP training at a local level. This can happen in
getting sponsor/site contracts signed. Often,
Regulations on GCP compliance in line with the
Brazil, Mexico, the US, Germany or Botswana,”
contracts must be drafted in Spanish (or
Document of the Americas are being drafted.
he says.
Portuguese in Brazil) to be valid. Therefore, they
Colombia
Furthermore, regulators are taking measures
must be translated back and forth between that
A resolution making adherence to GCP compulsory
to safeguard patients. Brazil, for example,
language and English, for the benefit of sites and
was published in June 2008. All bodies involved in
recently issued new guidelines on access to
the sponsors’ lawyers respectively. This is a slow
clinical trials were given six months to define a
after-care and the use of placebo in clinical trials.
plan for development and implementation and
process, says Dr Hurley. “One word can change
Both elements comply with the declaration of
compliance with GCP. They have two years to
a lot depending on the translator you use, and
Helsinki, the most widely accepted ethical
obtain GCP certification.
the document can be quite different by the end
guidance for biomedical clinical research, says
Peru
of the process,” he says.
Dr Kesselring. Meanwhile, the Buenos Aires
Regulations were updated in 2007 to achieve full
Nevertheless, the Latin American region is
Declaration on Ethics and Clinical trials was
compliance with ICH guidelines. Start-up times
undoubtedly moving forward. One major step
recently approved by the First Latin American
have been reduced by 1.5 months.
was the creation of the ‘Document of the
Workshop on Ethics and Clinical Trials (which
Americas’, which sets out the criteria for
took place in that city in May 2008). The groups
The region is also particularly attractive to
harmonised GCP in the region, says Ms Racaro.
behind the initiative hope it will become a
North American-based sponsors because of
It took representatives from Argentina, Brazil,
reference for guidance on ethics in the region.
its proximity. This means that sites can be
Chile, Costa Rica, Mexico, the US and Venezuela
However, it is yet to be accepted by the global
easily visited; this is particularly important with
10 years to draft before the document could be
pharma industry and national regulatory
proof-of-concept trials in which companies
approved by the Pan American Health
agencies.
need to access patients and data and to talk
Organization in 2005. It now serves as a
One additional challenge for Latin America
to investigators, says Dr Hurley.
guideline for investigators and agencies and is
will be to increase its pool of highly trained staff,
gradually being implemented on a country-by-
including investigators, says Ms Racaro.
regulatory progress
country basis. Argentina and Colombia were
Encouragingly, some progress has already been
Dr Hurley believes Latin America’s clinical research
among the first to incorporate it.
made on this front. Associations including the
“growth spurt” is a relatively new phenomenon,
As in other emerging regions, concerns have
Brazilian Society of Pharmaceutical Medicine and
and one that has thrown up a number of
also been raised over the ethical conduct of
the Argentinean Society of Pharmaceutical
challenges for its regulators. Much of the region’s
clinical trials. Critics claim investigators may
Medicine are addressing these training needs,
legislation was drawn up in the 1990s and a
recruit uninformed patients, who may be too
says Dr Kesselring. CROs and pharma
number of resolutions have since been drafted on
easily enticed because of otherwise limited
companies are also running training programmes,
a country-by-country basis. “It soon became
treatment options. However, such concerns are
as are universities such as the Federal University
obvious that some countries had so many layers
exaggerated, says Dr Kesselring. Investigators all
of Sao Paulo (UNIFESP) and the Sao Paulo
and disconnecting processes in ethics and
over the world are under pressure from pharma
Santa Casa Medicine College.
regulatory review processes. Reducing regulatory
companies and CROs to recruit and the sites
Sponsors will keep coming to emerging
and start-up timelines has therefore become a that recruit the most patients earn the most
regions, particularly as pharmaceutical companies
priority,” says Dr Gustavo Kesselring, president of money, he says. “If uninformed patients are
aim to increase the number of trials they
the Brazilian Society of Pharmaceutical Medicine. included in a clinical trial, it is down to problems
conduct outside of the US and Europe from
20-30% to 40-50% over the next few years, says
Ms Racaro. “They will definitely come to Latin
Table 3: Latin American retail pharmacy sales, 12 months to July 2008
America.”
Country Retail sales ($ billion) % growth
Brazil 12.2 +10
Mexico 8.8 + 5
Francesca Bruce is a
reporter for Scrip.
Argentina 3.0 +20
Total 24 + 9
Source: IMS Health
www.scripnews.com/supplements Scrip 100
93
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128