For the last 3 years, TIF has embarked on a new initiative, in the context of its continuous efforts to safeguard the quality of health care of patients with thalassaemia, residing all over the world. This initiative focused specifically on the education of patient/parent and health professional communities on the use of safe and effective drugs that are used in the management of thalassaemia and more importantly those that target to remove excess iron from the body i.e. iron chelators.

Iron chelators are by far the most important drugs that contribute to the survival of lifelong blood transfusion-dependent thalassaemia patients. In addition, other forms of β- (and combined forms) of thalassaemia, such as β-thalassaemia intermedia, HbE/β-thal, and α-thalassaemia such as HBH, as well as Sickle Cell Disease (SCD) syndromes, although may not require blood transfusions from a very young age, yet such treatment may become clinically necessary at a later point in their lives, and in this context iron chelation drugs will also constitute an important component of their effective management.

Moreover, it is worth-noting that the pathophysiology, of some of these forms, which for a long time were considered as ‘milder’ types of α- and β-thalassaemias (HbH and HbE/β-thal and Intermedia), follows a different pattern with regards to the accumulation of iron from that occurring in the β-thalassaemia major forms. This makes the use of iron chelators essential at some point in their lives, even in the absence of any blood transfusion therapy.

Beyond any doubt our priority is encompassed in four simple words: to increase accessibility, availability, and safe and effective use of drugs to our patients globally. In the context of national governments, and regional and international efforts to bring about equity to quality health for all, the use of cheaper Generic drugs is becoming a major tool for achieving accessibility and availability of drugs to patients across and between countries of the globe.

The use of cheaper drugs should, however, under no circumstances jeopardise their quality and effectiveness. “Nothing is truly more expensive, in the end, than a treatment failure from an ineffective drug or from a drug that causes side and adverse effects, leading to poor adherence, increase of morbidities and even fatalities”, noted the President of TIF, Mr Panos Englezos in one of his messages to patients and health professionals.
Generic drugs, since by definition, should be of equal quality and clinical effectiveness with those of the originator/innovator/brand-name drugs, they should also abide to strict national or regional or international regulations that ensure their safety and effectiveness. Although in many countries, companies producing generic drugs do follow such regulations and offer hope and optimism to patients worldwide, yet many other companies, particularly in ‘developing’ countries have either more “relaxed” regulationsfor generic drugs or non-existent at all, in place. TIF strongly expresses its grave concerns over such weaknesses that exist in many countries and considers that patients with thalassaemia who receive drugs from those companies are “at-risk”.

Further to TIF’s Position Paper PP5.3, namely ‘Counterfeit Medicines and Patients’ Safety – A global threat’ prepared and distributed in March 2012, TIF now embarks on a more ‘focused-targeted’ effort to raise awareness, and to sensitise and educate patients’ communities on their responsibility to know and to collaborate closely with every relevant stakeholder with regards to ensuring that the drugs they receive are Safe and Effective i.e. to demand full respect of their rights as patients and human beings.

In addition, TIF will actively target policy makers at every level, and it will actively integrate the use of safe and effective iron chelation drugs, in the context of its educational programme to reach out to the involved health professional community worldwide.

TIF recognises the need for equity of care across the world and that the market for cheaper generic iron chelating medicines will increase, in order to increase access to treatment for as many patients as possible.

The anticipated changes globally in drug spending is that 2017 Generic drug sales will increase from 27% to 36%, and the budget for drug spending will increase from 965 to 1,200 billion dollars. The most significant increase in the use of Generic drugs is expected to happen in the developing countries, where sadly the regulations on the manufacturing of Generic drugs in many countries are either “relaxed” or non-existent, at all. Furthermore, many countries of the developing world do not abide to EU and USA regulation and, are IP-free, with the opportunity to provide “copy” drugs well before the protection on the quality that the patency offers to the brand drugs is terminated. Such drugs are also of great concern and reliable transparent and updated information from the relevant companies on the manufacturing processes should urgently be made available to all: Governments, health professional and patient/parent communities.   

It is within the realms of this new initiative that is scheduled to cover all regions of the world that TIF organised its first Round Table Meeting on the use of Generic drugs in thalassaemia, mapping the situation in the Middle East and North Africa region (MENA). This meeting took place on Wednesday 29 July 2015, at the Chronic Care Centre, in Beirut, Lebanon – one of the Thalassaemia Reference Centres of the region, under the coordination of Dr Androulla Eleftheriou, Executive Director of TIF, and Dr Angastiniotis, TIF Medical Advisor, and the leadership of Prof Ali Taher, a member of TIF’s International Advisory Board and Head of its Regional Advisory Committee.

The Round Table meeting was in the format of a ‘brainstorming’ activity of key medical treating physicians from the MENA countries with whom TIF hopes to form the start of a strong and active network of health professionals with intent to fight for safety and effectiveness of drugs for all patients. This activity very importantly integrated the position, perspective and opinion of expert patients, including Mahmood Hadipour Dehshal – Pharmacist, Member of the Iranian Thalassaemia Association, Tehran, Iran and Sarunas Narbutas – President of Lithuanian Cancer Patient Coalition (POLA), Lithuania.

The meeting itinerary covered the areas of quality and safety of drugs with a particular focus on Generic drugs. A thorough report is expected to be finalised very shortly, by the editing committee, assigned by TIF, and a comprehensive plan of action for moving ahead will soon be circulated to its collaborators General, Voting and Associate members.

This first news press release which constitutes the consensus thoughts of the coordinators and participants, aims to inform all involved stakeholders across the world on the concerns and position of TIF with regards to this specific topic.

TIF’s position is ‘Drug Efficacy and Patient Safety’ should always outweigh the costs!

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