France has a mature healthcare market,
based on its high healthcare expenditure and pharmaceutical production. The
increasingly elderly population is expected to drive the growth of the
pharmaceutical market; however, an increasing focus on generics to reduce
healthcare expenditure will balance this out.
The French pharmaceutical market was
valued at $48.9 billion in 2008 and an estimated $45.9 billion in 2013. It is
expected to grow at a Compound Annual Growth Rate (CAGR) of 0.7% from
approximately $46.2 billion in 2014 to $48.2 billion in 2020.
The public health insurance system was
established in 1945, and by 2011, approximately 97% of the population was
covered under Statutory Health Insurance (SHI), divided into three main
schemes: general, agriculture, and non-salaried and non-farming (World Bank,
2014p). This universal healthcare coverage is expected to continue to drive the
French pharmaceutical market. The increasingly elderly population is also
fueling pharmaceutical market growth, accounting for 17.6% of the total
population in 2013 and expected to increase at a CAGR of 1.5% to 19.7% by 2020
(INSEE, 2014f).
The government is focusing on the use of
generics as a cost-containment tool to reduce healthcare expenditure. It
introduced a scheme in September 2012 to increase the use of generic drugs,
under which patients who agree to generic substitution will not be required to
pay for their drugs. The substitution rate increased from 71% to 84% in one
year as a result: a cost saving of approximately €200m ($270m) (Thomson, et
al., 2013). In 2008, generic drugs accounted for 9.4% of the pharmaceutical
market in terms of value and 21.7% in terms of volume, increasing to an
estimated 15.3% and 27.7% respectively in 2013 (ANSM, 2013). However, this is
expected to act as a barrier to the growth of the pharmaceutical market.
The French medical device market was
valued at $12.7 billion, which increased to $15.5 billion in 2013. It is
projected to grow at a CAGR of 5.1% from $16.2 billion in 2014 to $21.8 billion
in 2020. In 2013, In Vitro Diagnostics (IVD) accounted for 15.3% of the overall
medical device market, followed by cardiovascular devices (11.4%), ophthalmic
devices (10.7%), orthopedic devices (8.4%) and hospital supplies (7.4%).
A transparent and efficient regulatory
system combined with organizational reforms in the national regulatory agency
will attract the trust of pharmaceutical and medical device companies and
positively influence the French healthcare market.
In France, the National Security Agency
of Medicines and Health Products (Agence Nationale de Sécurité du Médicament et
des Produits de Santé, ANSM) is the main regulatory authority for
pharmaceutical products and medical devices. It came into existence on May 1,
2012 when it replaced the French Agency for the Safety of Health Products
(Agence Française de Sécurité Sanitaire des Produits de Santé, AFSSAPS). Its
scope has been extended to include monitoring authorized medicines, promoting
quick access to innovative drugs, and promoting academic research on medicine
safety.
The ANSM authorizes product approvals
under the national or community procedure through the European Medicines Agency
(EMA) and issues licenses for manufacturing, importing, exporting, and
conducting clinical trials. Approval for new drugs or medical devices requires
the execution of Good Manufacturing Practice (GMP) and compliance reviews by
the ANSM. The ANSM also plays a crucial role in assessing the benefits and
risks associated with the safe use of health products. It maintains
transparency by publishing committee proceedings, agendas, minutes and all drug
withdrawals online. Legally, assigning broad responsibility is expected to
increase the industry’s trust in the regulatory system and provide
professionals and the public with information which will facilitate
decision-making regarding any new Marketing Authorizations (MAs) (ANSM, 2014a).
The French healthcare system offers
universal insurance coverage, but the economic crisis and high public debt are
forcing the government to cut healthcare reimbursement.
The French healthcare system is
well-developed and offers universal healthcare coverage to all citizens. The
public insurance system is built on the principle that everyone must contribute
to the health insurance scheme according to their income and receive care
according to their needs, regardless of their place of residence. By 2011,
approximately 100% of the population was covered under SHI, which covers a
broad range of basic medical services such as hospital care, rehabilitation or
physiotherapy, ambulatory care and diagnostic services. Healthcare expenditure
is rising due to the large and growing elderly population, and the government
introduces periodic reforms to address this. Cost-cutting measures in 2011
included drug price cuts and the strengthening of generic provision. In 2011,
the government reduced the reimbursement rate for non-serious disease to 30%,
down from 35% in 2010 (PPRI, 2012).
The market for complementary Private
Health Insurance (PHI) also is well-developed, and covers user charges that are
not eligible for reimbursement by SHI, such as co-payments for psychologist or
dietician consultations. In 2012, SHI covered approximately 95% of the
population (Thomson et al., 2012).
Political instability, a rising
unemployment rate and net debt and falling GDP are affecting the economy, but
government initiatives are expected to bring stability.
France was the world’s fifth-largest
economy in 2013 with a Gross Domestic Product (GDP) of $2.7 trillion, placing
it below the US, China, Japan and Germany (IMF, 2014a). In 2013, it was the
second-largest economy in Europe behind its main economic partner, Germany
(CIA, 2014).
In France, the unemployment rate
increased from 7.4% in 2008 to an estimated 10.6% in 2013 (World Bank, 2014a).
In 2013, there were approximately 2,481,000 people unemployed, representing an
unemployment rate of 9.3% of the working population (INSEE, 2014m). The overall
increase in the unemployment rate is due to the eurozone crisis and resultant
drop in major industrial activity.
Government net debt amounted to
approximately $2.4 trillion in 2013, having increased by approximately $636
billion from 2008 at a CAGR of 6.4% due to the high unemployment rate and
increased healthcare expenditure, forming a barrier to economic growth. In
2008, GDP per capita was $45,789, which decreased to $43,000 in 2013 at a
negative CAGR of 1.2% due to the global economic downturn and subsequent
reduction in economic activity (IMF, 2014b). This indicates the decreasing size
of the economy, related to the monetary value of all production activities.
The government is taking steps to
improve economic conditions, having released a stimulus package in February
2009 of approximately $33 billion, intended to boost growth and employment
through investment in infrastructure projects and tax relief for the business
sector (BBC, 2008). It has also made changes to monetary policies and taxation
by increasing the top corporate and personal tax rates (CIA, 2014).
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