Prime Minister Edi Rama’s remarks at the National Agency for Drugs and Medical Devices:
The precious archive of Marubi dynasty, among many other records, documents also the early beginnings of pharmacy in our country. I recall now a very impressive photograph from 1896 – which I would propose to consider and hang it on these walls – showing Doctor Pashko Ashiku along with his workers and apprentices. They in that pharmacy wore all European dresses. The pharmacy was also a big pharmaceutical warehouse to store medicines, which back then were imported from West, countries like Italy, France, Germany and, a certain amount of them, from Istanbul.
Similarly, the archive features another picture showing another pharmacy and nursery run by Perikli Mozali, an activity launched in 1868 along with other famous and prominent figures and it operated also in Montenegro and Kosovo.
It is the humbly beginning of the history of Albanian pharmacy, but on the other hand it is an atypical history, compared to other countries, because the beginnings of organized sale of medicines in our country, until in the middle of the last century, trade, production and packaging were uncontrolled and legally unregulated activities.
For example, the first Albanian Parliament, the shortest-lived Assembly of Vlora in 1912, included individuals like Myerteza Ali Dibra, who had been graduated from the French University of Medicine in Istanbul and who ran a pharmacy offering drugs prepared according to recipes developed by him, didn’t clear the way to any discussions to put the drugs trade under control.
In the ’20s and’ 30s, Albania ratified several treaties, adopted several laws in a bid to establish a system of rules, but, in the meantime, the country’s capacities were such that it lacked a laboratory or a proper pharmaceutical industry.
In the first ten years after the war, the then authorities made just two decisions about medicines; a decision to ratify an international control protocol adopted in 1931, which was ratified in 1949, 18 years after its adoption; and another decision in 1951 to control prices in the drug market. It was only in 1965 when Albania established the state drug control laboratory, which is also the predecessor of the National Agency of Drugs and Medical Devices where today we share together an important transforming moment. The laboratory at that time established absolute control, because the system was based on absolute centralization. What is worth recalling is that the import of medicines was totally centralized and on the other hand any kind of Western medicine was strictly prohibited.
The current Agency was founded in 1991, a de facto restructuring of the existing structure, but just like many other restructuring processes carried out in the post-regime change period, the system kept its communist-era DNA in terms of operating. In other words, a set of structures that were reorganized as if they were really reformed during the communist system, which brought about long delays and deficiencies. Indeed, the Agency has exercised limited control over medicines that entered the country directly and a detailed control of the effect of thousands of legal or illegal drugs that flooded Albania.
I believe that the turning point towards normalization and alignment of our drug control system and medical devices with the European system has commenced with the adoption of a piece of legislation in 2014, when we set some clear rules, expanding the scope of activity of the Agency and aligning it with that of the European Medicines Agency, the institution representing all national agencies of the EU member states. Until then, in 2014, the Agency was unaligned; a body unable to integrate in the European system, whereas today we have reached to the point we are seeking, and I believe we will succeed, to accredit the Agency’s new laboratories to the European Union.
Today, we have not just a new physical Agency’s building, which is part of the whole; because I see that anytime we intervene in a physical building the common allegation is: this is a facade, it is corruption and exaggerated luxury. It is unimaginable how one can find courage and say it is normal to let civil servants, lab workers here work in miserable conditions in terms of space at the workplace.
But this is not the case of a totally transformed building in physical terms and the interiors, but this is the case of an investment where, if the total number of test that the communist-era laboratory, despite its technological deficiencies, was around 300 daily, today’s capacity is at least twice as much and it is about tests that meet European standards.
This Agency ushers in a new era today. And I want to tell few words to all of those who might rightly ask, why it took seven years for this?
But it’s neither this, neither that, nor that over there, it’s not even that behind our back, it’s not even what we do not see, but they are all, whole. The whole situation where the reforming intervention had to alter a reality inherited for decades, such as the reality of water supply, or a reality distorted in the decades after those previous decades and completely infected.
Of course, if these all were to be done two or three decades ago, we would be talking about completely different things by now. But it is not us to be blamed for others who have wasted 30 years. What I would like to reiterate is that we, not today, but for several years now, have cut the drug prices by at least 30%. Few years ago, Albanian patients had to pay a 30% higher price, without even knowing what kind of medicines they were using.
The today’s medicines prices are 30% lower and a total of over 8 million euros is saved from out-of-pocket spending on medicines for families each year.
And we are talking about the 10% tax rate. Patients used to pay an additional 10% over the real price for every aspirin pill. This tax has been removed for years now and the reimbursement fund has been increased by one fourth. A total of 191 drugs less than today were reimbursed in 2014.
The range of diagnoses and number of patients benefiting medicine reimbursement has been expanded.
Not to mention the various health packages, for example, the free diabetes test strips granted to all individuals aged over 25 years old.
The famous free herceptine for all women being treated for breast cancer.
For the first time, Albania is included in the European Pharmacopoeia. This was out of question just few years ago.
Of course, it doesn’t end here. We are working to expand medicines reimbursement list. We are working to endorse a significant pay rise for health workers, from doctors, nurses to lab workers here, who enjoy same workplace conditions like their European peers, while the only thing they had in common with European colleagues few years ago was their white coat.
A small museum showcasing equipment dating back to 1962, which were operational not long time ago, is located at this building’s entrance. I was not born yet! Ogerta was not planned at all back then. Let alone these boys and girls here, who were born, I believe, in the’70-s and’80s.
A beautiful Chinese proverb says: “It is easy to get a thousand prescriptions but hard to get one single remedy.”
Offering a recipe is not an issue here, because everyone is a pharmacist who claims he can heal the economy, he can heal unemployment, and he can heal corruption and everything else with his recipe. And of course, he is a pharmacist during the daylight and a football coach during on weekends.
But recovering and healing is a process that requires not only right prescriptions and, luckily enough, we already have the right prescriptions. If we were not to have them, then healing and recovery wouldn’t work. Quite the opposite, healing is working fine. Here we are, here it is the University Hospital Centre, which just seven years ago was a place where you were to be very fortunate if you were to find doctors, distraught and confused wandering amid mess, ruins and destruction here, where only doctors and their knowledge kept health system intact and operational, because no system existed indeed. And it was not 70 years ago, but only seven years ago when footages of people gathering behind the surrounding walls with prescription papers in their hands as it was completely impossible to be delivered direct care at hospital, and instead they had to buy medicines on the streets, or when patients had to bring sheets with them in order to be hospitalized. Doctors had only their hearts and mind, their knowledge and professional commitment to work under primitive conditions, abandoned and sunk into oblivion.
One of Tirana’s biggest local markets operated at the entrance of the University Hospital Centre, with vendors offering fruits and vegetables and clothes, as well. This was the right address for these products. Where? Right at the hospital doors.
But it is completely different today. Of course, a lot remains to be done, but it is a recovery process that takes patience and commitment. We posses both of them and we will keep delivering.
I would like to extend my best wishes for every success to the personnel here, expressing at the same time my sympathy and sorrow for their sufferings, especially the lab workers who have a longer experience, but, finally, at least in the remaining years before retiring, while the specialization programs continue and younger professionals will replace the old and most experienced ones, will have years of professional work, where they will enter here as professionals, will live the working day as professions and where they will leave with the pleasure of doing their job in professional conditions. Not to enter here, as they have entered for years, as professionals, but without any instrument with them, but only with passion, patience and the haunting shadow of humiliation.
The National Agency for Drugs and Medical Devices represents today the latest landscape of a transforming investment in health system. Totally ruined for decades, this important structure is being rebuilt from scratch to house state-of-the-art laboratories and its sectors will be overhauled to operate under a new structure.
The Agency’s obsolete technology from the ‘60-s, now displayed at the museum corner, has given way to modern equipment and devices. “The lab’s old devices were operational until lately. This technology dates back to 1962. We also have old-school devices that were used in various countries until 1990s. They have been all replaced by state-of-the-art digital devices and equipment that meet highest European standards,” the Agency’s Director said.
The Minister of Health and Social Protection Ogerta Manastirliu said that thanks to the government investment worth of EUR 1.7 million, the labs installed for first time ensure higher quality of the medicines in the market. “The Medicines and Medical Devices Agency used to operate under the most miserable conditions a health care institution can operate, since entire pharmaceutical service, drugs’ registration were practically carried out by one structure like the Agency for Drugs and Medical Devices, previously known as the National Centre for Drugs. The Agency’s premises have been completely rejuvenated under a government-funded investment project worth EUR 1.7 million. The Agency has been supplied with new equipment. What really makes this investment worthwhile are the labs, which for first time are specific labs, the physical, chemical and microbiological labs for complete tests of drugs, radically improving the quality of drugs in the market,” she said.
New technology now allows for accurate tests of a variety of important drugs, which could not be tested before. “This is the room of new devices, where we have managed to test a range of drugs that could not be tested until lately. For example, anticancer drugs that can now be tested through these devices,” the Head of the Agency said.
Special attention has been attached to improvement of online services, the range of which will be expanded. “One of the elements we are seeking to improve is the whole range of online services. Therefore, in all sectors where drugs are registered, online systems have already been established via e-albania portal. All services are applied online and we are continuing to expand the range of online services. ”
While the sector of authorization for regulatory issues, non-existent until today, is a new structure in the Agency. “Until 6 years ago, when the law on drugs and pharmaceutical services had yet to be approved, drugs in the Albanian market, not only were on average 30% more expensive than in the country of origin, but also did not have the opportunity to have a reference to their control , because this structure did not exist, ”Health Minister Manastirliu said.
Accreditation now remains a challenge because this will make it possible to issue certificates that will be recognized by international institutions. “The challenge is accreditation because if we do not have accredited laboratories, then we cannot issue certificates to be recognized by international institutions. Meanwhile, with this investment, we enter the series of countries that can test locally-produced drugs,, of course, but also imported ones,” Manastirliu said.
On their part, workers serving for years in this health care institution say these are the best possible conditions for them to exercise their profession. “We would like to thank government for creating such conditions. I am sure countries in the region will envy us for the modern devices, equipment, the quality work we can do here,” one of the lab workers said.
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