Independent agencies to administer pharmaceuticals ‘essential’

March 17, 2016

* By Kyriakos Mikellis
Κυριάκος ΜικέλληςIn most European countries, unlike Cyprus, policies on pharmaceuticals give patients access to the treatment their doctors consider the most appropriate. Pharmaceuticals and pharmaceutical care are usually the responsibility of three independent agencies, each with its own area of responsibility, thereby ensuring that patients have access to the best quality pharmaceutical care possible. These three agencies are:

Regulatory Agency
The Regulatory Agency is responsible for licensing pharmaceuticals, controlling and supervising marketing (pharmacovigilance), licensing and supervising pharmacies, and monitoring drug manufacturing factories as well as the importers and distributors of pharmaceuticals. In general, the Regulatory Authority is responsible for ensuring that the patient receives safe and effective treatment. One example of such a service at the European level is the European Medicines Agency, where manufacturers apply for centralised European approval of pharmaceuticals and whose decisions apply to all EU Member States. Additional examples include the Medicines and Healthcare Products Regulatory Agency of the UK (MRHA) which regulates the marketing of pharmaceuticals in the United Kingdom and the National Pharmaceuticals Organisation (EOF) in Greece.

Evaluation Agency
This agency’s main responsibility is to evaluate new pharmaceuticals and medical devices approved by the Regulatory Agency following an application by the marketing authorisation (manufacturers) holders so that their products can be marketed and prescribed to patients. These agencies are independent with a legislative mandate so as to have the most credibility. As a rule, its members are comprised of health experts such as academics in the health sciences and those versed in pharmacoeconomics. Other stakeholders such as patients, doctors, pharmacists and industry representatives also participate so as to ensure that procedures are transparent, timelines are adhered to and decisions are taken based on substantiated and verifiable criteria.

Recognising the importance of these procedures and services for citizens, the European Union issued a directive in 1989 (89/105/EEC) regulating procedures to determine prices and to introduce pharmaceuticals into health systems. This directive is known as the Transparency Directive because it sets out procedures which promote transparency within specific timeframes. Agencies such as the IQWiG in Germany, NICE in the UK, SMC in Scotland, HAS in France, TVL in Sweden and others evaluate and recommend the inclusion or not of new pharmaceuticals into the state formularies. In cooperation with scientific medical committees these organizations are also responsible for drawing up guidelines. An equivalent to this procedure must be introduced in Cyprus as well. If we find that this is beyond our capabilities as a country, we should not attempt to reinvent the wheel. We always have the choice to adopt decisions of other countries, particularly those with high quality medical care such as Sweden, Germany, Israel and Switzerland.

Reimbursement Agency
The main responsibility of the Reimbursement Agency is to supply pharmaceuticals to patients. Essentially this is the Agency called upon to implement the decisions of the Evaluation Agency. The required monetary fund is set up using revenue from citizens’ special contributions, from mass contributions, or from tax contributions. The Reimbursement Agency covers the biggest part of the cost while a nominal part is covered by the patient, also known as a co-payment system. The individual patient participation in the cost of treatment serves to control use and should be kept at a low rate, while the patient must not be discouraged from using the appropriate pharmaceutical treatment because of cost.

To a large degree Cyprus lags behind the rest of Europe in regards to the management of pharmaceuticals since it has not yet set up a similar structure which would ensure the independence of the three agencies set out above.

We expect that the state will adopt a structure similar to other European countries in regards to the administration of pharmaceuticals the soonest possible, and not necessarily with the implementation of the NHS. Such a system should safeguard transparency in decision making within specific time frames while at the same time aiming to improve quality pharmaceutical care for Cypriot patients.

*President of the Cyprus Association of Research and Development Pharmaceutical Companies (KEFEA)