EU must ensure medicines research responds to patients' needs
It's time to review the relationship between the public and private sectors in the development of new drugs, writes Soledad Cabezón Ruiz.
Soledad Cabezón Ruiz | Photo credit: European Parliament audiovisual
The increase in the price of medicine, or the high price at which those considered innovative go on sale, means that currently in the EU, pharmaceutical expense represents 17.1 per cent of total expenditure on health and 1.41 per cent of the bloc's GDP. This has generated concern for the sustainability of our health systems and inequality of access for citizens.
For example, in the US, just 2.4 per cent of the population has had access to curative hepatitis C treatment - Sofosbuvir - through Medicare, due to its high price. In the EU, meanwhile, there is no data yet, but a few member states have introduced this medicine into their social security portfolio, with varying restrictions.
We must never lose sight of the fact that our European public health systems are shaped on the universal right to health, which includes access to medicine - this right is hugely valued by our citizens.
In addition to the high price of medicine, there is also concern about people's needs not being addressed in areas that are of less commercial interest.
While there are 13,700 molecules in the pipeline, with 6900 in the clinical development phase, there is no effective treatment for so-called neglected diseases - or 'diseases of the poor' - rare diseases or antimicrobial resistance, which causes 700,000 deaths a year due to a lack of suitable antibiotics. This has led to public incentives, whether through public financing of research or market exclusivity, among other things.
We must also bear in mind the paradigm shift that is occurring - or a new medicinal era - and has been caused by two things. First, demographic change, with increased life expectancies and lower birth rates - which is in itself a challenge to public healthcare systems.
Second, advances in the field of genetics, which have opened the door to treatments for previous incurable diseases, as well as personalised therapies or therapies for subgroups of patients, which in turn opens up a reflection on the type of studies necessary around authorisation of the drug in question.
The measures initiated so far, such as incentives for the development of treatment for rare diseases in the EU, US or Australia, have taken into account the need to consider healthcare challenges in a more general sense.
Although this has led to an increase in available treatments, there is concern about the effectiveness of many drugs - primarily cancer drugs - not having been proven, yet still come with a hefty price tag, despite public contribution to research.
In the EU, in 2012, 874 orphan medicinal products were authorised, and currently 1800 molecules are being developed. There has been an increase in both expenditure and use, from 13 to 24 per cent and seven to 17 per cent respectively between 2009 and 2010, with an average price of €150,000 a year for France, Germany, Italy, Spain and the UK.
In the US, 326 orphan medicinal products have been authorised in the 25 years following the launch of incentives, but they currently make up more than half of all yearly authorisations. These are drugs that only account for five per cent of treatments for over 7000 rare diseases.
Certain regulations are subject to what has come to be known as the 'salami strategy', where an orphan medicinal product can be authorised for uses other than its intended purpose. This had led to questioning around these incentives and measures put in place to control them; in Germany for example, an orphan medicinal product ceases to be considered as such once it exceeds 50,000 sales.
The incidence of new cases of cancer is expected to increase by 68 per cent by 2030 compared to 2012, with around 23.6 million new cases each year in Europe.
Through genetics, it's possible to identify the typologies of cancers that affect small groups. The pharmaceutical sector tries to associate these medicines with the orphan medicinal product name with a high return, even though in most cases the effectiveness of the treatment is not proven or means increased life expectancy of months.
There needs to be a review of the relationship between the public and private sectors and incentives, so that we can guarantee that public investment responds to the needs of patients.
For example, we should review the authorisation process for medicine, so that prices are not fixed based on the value granted by the industry, but rather on criteria which can balance benefits between the private sector and society. Evaluation of added therapeutic value, compared to the best possible alternative, is crucial, along with other factors such as cost-effectiveness, efficiency or budgetary impact, among others.
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