Daniel Boda, National Agency for Medicines and Medical Devices (NAMMD) of Romania

Release Date: 2011-08-24

Under various former names for over five decades, the Agency has undoubtedly played a key role in setting a regulatory framework for Romania’s pharmaceutical market. Over these five decades, thorough changes in the political regime, subsequent regulatory changes, the emergence of new institutions, and many other factors have drastically changed the landscape of the pharmaceutical market in the country. What have been the key milestones that really shaped - and advanced - the regulatory framework of Romania’s pharmaceutical market?

For over 50 years, the present Agency has represented the drug regulatory authority in Romania. Known as the Institute for Medicinal Product Control and Pharmaceutical Research on its setup in 1956, the name of the institution was further changed in 1960 to become the Institute for the State Control of Medicinal Products and Pharmaceutical Research (ICSMCF). Between 1999-2010, by reorganisation of the former ICSMCF, the institution operated as the National Medicines Agency.

The National Medicines Agency (NMA) has continued the ICSMCF tradition in regulation and control of medicinal product quality in Romania. Establishment of the NMA did not occur for reasons of an institutional scientific or professional void, but out of a change in philosophy, which was closer to that of its EU institutional counterparts, involving significant transformation of vision and principles, occurring gradually within a process of connection to European vision and practice in the field. The decisive factor for the evolution of the NMA since 1999 has been the adoption of defined benchmarks, meant for constant guidance of its policies and practice: European landmarks and primarily those of the then newly established European Medicines Agency (EMEA, currently the EMA).

On 01.01.2000, based on provisions of Order of the Minister of Health no. 802/1999, the NMA structure also included the Centre for the State Control of Biological Products for Human Use, which meant further undertaking by the Agency of the role of Romanian competent authority for biological products for human use and brought about additional tasks as well as an extended stakeholders range.

Main NMA professional activities have been carried on by the NAMMD:

- marketing autorisation and related activities (approval of variations as well as clinical trials, advertising material, pharmacovigilance, direct communications to healthcare professionals on medicinal products)
- medicinal product quality control
- pharmaceutical inspection activity
- regulatory work under the Ministry of Health coordination
- Pharmacopoeia related activities
- quality management activities.

Before Accession to the EU in 2007, the NMA had 26 active observers in EMEA scientific committees and working groups, the most effective means allowing the National Agency to preserve its connectedness with European activities in the medicinal product field.

Through Romania's accession in 2003 to the Convention on the elaboration of the European Pharmacopoeia, the quality standards of the latter have become mandatory for all raw and starting materials and medicinal products both manufactured in Romania and imported ones.
In June 2006 Romania emerged on the EudraNet map, as result of the NMA successfully connecting to the network of European drug competent authorities in medicinal products for human and veterinary use, under EMEA permanent coordination and monitoring.

The NAMMD is a public institution under the Ministry of Health supervision, founded by Government Emergency Ordinance No. 72 of 30 June 2010 on reorganisation of certain healthcare facilities and amendment of certain regulatory provisions in the healthcare field, due to the merger of the National Medicines Agency (NMA) with the Technical Office for Medical Devices (TOMD). NAMMD organisation and operation were approved by Government Decision nr.734 of 21 July 2010. As shown in the text of Government Emergency Ordinance No. 72/30 June 2010 itself, the grounds for the NAMMD foundation was increased efficiency of healthcare institutions in line with Government priorities for public administration reform, establishment of economic and financial measures for budget funded institutions under the Ministry of Health supervision, in result of the severe economic recession. The consequence has been addition to the Agency's mission of new obligations related to the field of medical devices.

Through its specialists appointed as members, the NAMMD currently actively participates in committee meetings and scientific working groups of the EMA and other bodies in the medicinal product field. This is the most effective means for the National Agency to make effective contribution to the good progress of European activities in the field of medicinal products for human use.

The activity related to medical devices was set up 50 years ago as well.

As early as 1958, the technical directorate of the Ministry of Health set up its own laboratory for technical testing of medical equipment, which became a distinct entity in 1973 within the Station for Verification and Maintenance of Medical Devices (SVMMD). As of 1 February 2005, the SVMMD has been reorganised under the name of the Technical Office for Medical Devices (TOMD), which in its turn merged with the National Medicines Agency (NMA) in 2010.

As far as medical devices are concerned, the NAMMD is in charge of control of the performance and security of medical devices in use as well as assessment of the capability of organisations providing services in this area.

NAMMD issues an organisational strategy in the context of the legal framework establishing the relation between the NAMMD and the Ministry of Health, as well as between the NAMMD and its stakeholders. It covers a 5-year period and is updated every year.


An important area of concern for all regulators worldwide, remains to be the counterfeit medicines. As supply chains have become increasingly international and as the sales of medicines through new media such as the internet have become increasingly popular, the challenges for regulatory agencies have inevitably been changing. If we compare the current situation to roughly one decade ago, do you see this battle as more challenging? What measures can be taken to align policy with the international community?

As the competent authority in the field of medicinal products for human use, the NAMMD has fully taken up its important role in combating medicine counterfeiting and illegal medicinal product trade and has continued in recent years to inform and warn the public as well as develop collaboration relationships with other institutions and bodies involved in this activity. In that respect, the NAMMD has continued collaboration with national institutions involved in combating counterfeit medicines sales over the Internet, as well as with their institutional counterparts in EU Member States or outside the Community, to limit these criminal phenomena, which sometimes can have serious consequences on public health. For permanent information of the public thereof, in 2010 as well work continued for update of the "Counterfeiting" heading on the Agency website, reporting counterfeit information transmitted through the rapid alert system.

NAMMD specialists appointed to attend meetings of the EU Council Working Group for medicines and medical devices have in recent years expressed and supported Romania's views on two draft directives amending Directive 2001/83/EC establishing a Community code on medicinal products for human use, envisaging both avoidance of penetration of counterfeit medicines into the authorised distribution chain and pharmacovigilance issues.

To the best of our knowledge, there are no counterfeit medicines in the legal authorised network for distribution of medicinal products for human use in Romania. Medicines with falsified source, identity or history only penetrate our country via online medicine trading.

As in other countries, the main counterfeit medicines are those for treatment of erectile dysfunction, weight loss medications, or antibiotics, purchased over the Internet or on the black market. According to the Anti-Counterfeiting Association (REACT Romania), Viagra, used to treat erectile dysfunction, is the most commonly counterfeited medicinal product in Romania.

The Agency performs an anti-medicine counterfeiting and illegal trading activities, for information and warning of the public as well as for development of collaborative relationships with other institutions and bodies involved in this activity. Thus:

- For better information of the public, a new "Counterfeiting" heading was established on the NAMMD website in 2010, including counterfeit reports coming through the rapid alert system.
- In 2009, the NMA initiated and completed a protocol regarding collaboration with the Directorate for Organised Crime and Terrorism Investigation (DIICOT) to combat drug counterfeiting and their illegal trading.
- The Agency has appointed a representative to meetings of working groups on combating counterfeiting, set up by the European bodies in the field, on which occasion the appointed NAMMD representative presented and supported Romania’s views in that respect.

Selling medicines over the Internet is prohibited in our country. The measure has been appreciated by the Pharmacists Employers’ Association in Romania. Medicines traded over the Internet are not safe, 30% of them being counterfeit, according to some studies, whereas according to the World Health Organization, more than 50% of medicinal products sold over the Internet are counterfeit.
While pharmacies in Romania are now prohibited from selling medicinal products over the Internet, online pharmacies are legal in other European countries, within a well-defined national framework.

European Parliament members have considered it necessary to regulate sales of pharmaceuticals over the Internet, which is one of the main routes for counterfeit medicinal products entering the European market. All licensed online pharmacies will be provided with a link to a central site in each Member State and will be listed on that respective website. In turn, the various national websites will provide a link to a European website. At the same time, citizens will have to be informed on the risks involved in buying medicinal products online.

The first meeting of the NAMMD management with mechanisms involved in establishment of the Romanian legal framework for product traceability, occurred in December 2010; it was a meeting aiming at identification of all elements as possible starting points for viable solutions for its set up.

On June 8, 2011, after years of intense debate, the European Parliament and the Council adopted DIRECTIVE 2011/62/EU amending Directive 2001/83/EC establishing a Community code on medicinal products for human use with regard to prevention of counterfeit medicinal product penetrating the legal supply chain.

The new Directive provides for measures to be implemented by Member States to ensure increased and effective coordination on international level to warrant effective strategies to combat counterfeiting, particularly in terms of medicines sales over the Internet. As shown even in the Directive itself, the Commission and the Member States should cooperate closely and support ongoing work in international fora on this subject, such as the Council of Europe, Europol and the United Nations. In addition, the Commission, working closely with Member States, should cooperate with the competent authorities of third countries with a view to effectively combating the trade in falsified medicinal products at a global level.

The Directive requires EU Member States to implement laws, regulations and administrative provisions necessary for compliance before January 2, 2013, the date for Member States enforcement of those provisions.

While some of the multinational pharmaceutical companies have been actively conducting clinical research in Romania, there is still a vast potential to ramp up an untapped clinical trial potential. Having the right regulatory framework is therefore not only important to attract such activity to the country, it is further imperative to ensure patient safety in the first place. How does NAMMD provide a framework for clinical trials that strikes the balance between patient safety and a smooth authorization process for the industry? What will the further harmonisation with the EU directive on clinical trials bring to Romania?

Member States, Romania included, are known to have drafted legislative proposals related to a Regulation/Directive for amendment of the Clinical Trials Directive - Directive 2001/20/EC of the European Parliament and the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. This proved necessary because of the Community context created by the significant criticism mainly with regard to the varying manner of transposition of the Directive in the different Member States, involving increased administrative load and discrepancy between legal provisions in the field and the global rising tendency of clinical trials.

To briefly outline proposals for current provisions amendment, the need should be highlighted of the following:

- More efficient/simplification of the clinical trial authorisation procedure through joint assessment of applications for authorisation;
- Clarification of certain provisions of the current Directive;
- Adoption of the new legal provisions as a Regulation – directly applicable into national legislation and not as a Directive, in order to avoid differences in transposition manner on national level;
- Revision of application guidelines;
- Voluntary cooperation for resolution of difficulties encountered.

New regulations have the following goals:

1. Ensuring an up-to-date regulatory frame that takes into account multi-national research and needs of a highly innovative pharmaceutical sector based on research, providing support mainly to the process regarding assessment and follow-up of clinical trial applications against a multinational background;
2. Adapting to practical needs, constraints and needs without compromising the safety, well-being and rights of clinical trial participants;
3. Ensuring a global character to clinical trials for harmonisation on world level, at the same time complying with good clinical practice regulations.

Analysis of the national context results in the following conclusions:

1. Romanian legislation transposes all clinical trial-related directives (as orders of the minister of health) and the greatest majority of European guidelines existent in volume 10 of the EudraLex (as Decisions of the NMA/NAMMD Scientific Council)
2. From the standpoint of social-economical implications, the following are expressly necessary:

o Improving safeguard of clinical trial participants’ safety, well-being and rights;
o Reducing costs and administrative load for sponsors and investigators;
o Facilitating clinical research on medicinal products, particularly with regard to multinational clinical trials involving disorders of reduced incidence (e.g. rare diseases) for which additional research is essential;
o Strengthening clinical trial reliability globally.

3. As far as legislative implications are concerned, the need arises for further amendment of orders of the minister of health and decisions of the NAMMD Scientific Council resulting from amendment of Directive 2001/20/EC.

Romania’s preliminary position has resided in:

- Clarification and improvement of definitions provided in the current version of the Directive (e.g. regarding non-interventional studies, investigational medicinal products etc.);
- Simplification and harmonisation of the procedure related to reporting of serious unexpected adverse reactions in clinical trials;
- Clarification and update of labelling requirements for all categories of investigational medicinal products;
- Classification based on clear criteria of clinical trial phases;
- Contribution with clarifications on documents required for special medicinal products (genetically modified medicines, radiopharmaceuticals, advanced therapies medicinal products);
- Additional clarification on terms in the application form for clinical trial approval.

Romania’s regulatory and harmonisation perspectives in the clinical trial field are focused on:

- Transposition/translation and adaptation of European provisions in the field (as orders of the minister of health/Decisions of the NMA/NAMMD Scientific Council);
- Ongoing use of the updated version of the European Clinical Trial Database-EudraCT (in line with the current version of the Directive)
Improving use of the EudraCT through participation in meetings of the EudraCT TIG (Technical Implementation Group)
- NAMMD assigned representatives’ participation in meetings of the Clinical Trials Facilitation Group (CTFG) (starting as early as 2008), a Heads of Medicines Agencies-HMA working group, established for coordination of Directive 2001/20/EC implementation in all Member States on national level;

o Within the CTFG, a procedure has been established for harmonised assessment of multinational clinical trials: the Voluntary Harmonization Procedure-VHP, running for two years now and still in its pilot stage, also involving Romania from the very start;
o VHP goal is focusing clinical trial assessment on subject safety as well as on quality and safety of investigational medicinal products.

Institutions with clinical trial-related responsibilities: The National Agency for Medicines and Medical Devices, the Ministry of Health, the Ethics Committee.

Renowned for its expertise in providing accurate and timely information on medicines being made available to Romanian patients, NAMMD has a prime role in raising health literacy levels in the country. With an estimated 10 million Romanians still lacking proper access to healthcare, there are clearly challenges to raise health awareness too. How does NAMMD set its priorities to optimize the spread of information to its stakeholders, and what role do you see for the Agency to help raise the level of health literacy in Romania?

The NAMMD has elaborated a 5-year Communication Strategy, describing the frame for internal and external communication in this period, establishing key actions for developed communication. The Communication Strategy is renewed on a yearly basis.

The main objective of the Communication Strategy is attainment of a higher degree of understanding of the risk/benefit balance assessment and of the manner of NAMMD decision making in performance of its assignments, as well as encouragement of adverse reactions/events reporting.

Much has been accomplished to this end over the past years and the NAMMD will further improve the transparency of its own activities and its accessibility to the public. The NAMMD will also promote transparency in the activity of the industry under its regulatory scope.

Among the NAMMD strategic priorities, closer and more effective engagement will be necessary with patients and general public associations, as with identification of general ways of bringing patient perspective in its work.

For attainment of its mission, the NAMMD aims at continued approach of those strategic priorities related to development of communication activities, as for example:

• Improved flow of information to healthcare professionals
The NAMMD is aware that the first contact of most patients and the general public is public healthcare services and treating healthcare professionals, respectively. Therefore, healthcare professionals should be timely provided accurate high quality information able to aid them in advising their patients on use of medicinal products for human use.

That is why the Agency has focussed its entire attention on continued efficient provision of key information for healthcare professionals in that respect, in order to adequately support their or other people’s patient care activity.

In this respect, the NAMMD will pursue:

- Review and update of its website for better accessibility of information for all stakeholders, healthcare professionals included;
- Assessment of communication channels currently used in relation to healthcare professionals: rapid alerts, current pharmacovigilance issues (information letters for physicians / direct communications to healthcare professionals, notifications to medical practitioners, pharmacovigilance regulations, submission of Summaries of Product Characteristics, patients leaflets etc.).

• Improved NAMMD profile as a communicator

The NAMMD fully assumes responsibility for the communicating with the media relationship, in a context of increased demand for printed press and television interviews, the NAMMD will continue to promote a fair and efficient relationship with the press, given the increasing societal role of the media in recent years. Accurate, rapid and impactful information conveyed in appropriate terms in the field of medicinal products for human use as well is a vital source for any type of decision, and the media is its main means of dissemination to the general public.

Considering that, in addition to its informative role, the mass media can also be used to shape opinion and ideas and develop attitudes, the NAMMD relationship with the press must be built in such a way as to ensure accurate, clear and appropriately expressed medicines-related body of information, particularly related to safe use, in order to achieve a maximum degree of understanding by the general public. To a lesser or greater extent, this relates to the Agency's control over information on medicinal products for human use, and a good relationship with the press is compulsory to achieve this goal.
In exercise of its duty as a proactive and reactive communicator, the Agency aims at ensuring a balance between its work and the issues it faces.

• Improved involvement in Agency work of patients and the general public

Priority will be given by the NAMMD to continued direct communication with patients and general public associations allowing identification of more opportunities for their involvement in agency work, such as:

- planning meetings with patient / public groups of interests for proposal of specialists to participate in their meetings;
- creating a patient / public "reference group" able to, within its collaboration with the NAMMD, contribute to improved decision making and level of understanding of safety issues and risk in prescription and use of medicinal products for human use.

• Promotion of informed debates on the various aspects involved in medicinal products for human use:
-the benefit / risk balance,
-generic versus innovator medicinal products,
-patient role in development of readable leaflets able to assure a high level of understanding,
-reporting adverse reactions, etc..

- Debates on the issue of non-existence of risk-free medicinal products, the essential point being a positive benefit / risk balance provide better understanding of Agency work and set an example for transparency promotion in NAMMD policy and strategy, as the national regulatory authority in the field of medicinal products for human use.
- Continued debate on generic versus innovator medicinal product and initiation of debates on the involvement of professionals and patients in implementation of the new European Directive 2010/84/UE for amendment of Directive 2001/83/EC establishing a Community code on medicinal products for human use in terms of pharmacovigilance.

Some of Europe’s leading regulatory agencies have taken various measures to enhance internal efficiency, effectiveness and transparency. When Focus Reports met Kent Woods of the UKMHRA last January for example, becoming more cost-effective had become one of Mr. Woods’ internal priorities. In your view, what measures can be taken to cut bureaucracy, enhance cost-effectiveness and increase productivity within the NAMMD?

Staff represents the NAMMD most important resource. Enforcement of efficient regulation for protection of public health requires preservation of highly qualified and motivated workforce.

This goal is particularly difficult under the present circumstances when current public system possibilities to reward its employees can hardly compete with opportunities on the private market, that have attracted specialists whose expertise is due to their work in the Agency.

The NAMMD will have to further its efforts to preserve its currently available staff with regulatory and scientific expertise, providing at least motivation through adequate assessment of performance and acknowledgment of professional competence, respectively, until creation of a favourable legislative context allowing for appropriate financial motivation for reward of special professional merits.

Depending on the development of the current economic crisis, the NAMMD seeks to:
• Perform efficient recruitment and selection of new staff, particularly from among new graduates of medical-pharmaceutical higher education.
• Implement promotion policies to ensure the human resources in the NAMMD, mainly in areas where analysis reveals deficits of personnel of higher education;
• Provide staff with a wide range of professional training and opportunities for improvement, for developed human resources.

At the end of 2009, the Agency was reorganised as a public institution fully funded from the state budget, in accordance with Law No. 329/2009 on the reorganisation of certain authorities and public institutions, rationalisation of public expenditure, support to business and compliance with the framework agreements with the European Commission and the International Monetary Fund.

On legislative level, in 2009-2010, regulation continued of certain financial-fiscal measures with significant negative impact on the management of human resources and implicitly on the funding of the entire operation of the Agency.

Set up in July 2010 through National Medicines Agency (NMA) merger with the Technical Office for Medical Devices (TOMD), the NAMMD aims at least maintaining its financial stability by means of a balanced budget exercise within the limits of the allocated budget in compliance with legislation in force.
The NAMMD periodically updates its tariffs depending on changes in its activities.
The NAMMD aims at further finding activities able to enhance its income, such as organising conferences, training sessions etc.

What is your final message to the different stakeholders of the healthcare and pharmaceutical sectors, and the international readers of Pharmaceutical Executive worldwide?

I would first of all like to ensure you and the international readers of the Pharmaceutical Executive that our organisation ensures effective communication with its stakeholders, so that their needs and expectations are identified, translated, as appropriate, into organisational requirements, and feedback is given.

I would in particular like to go further along these lines for the very reason of informing your worldwide readers on the fact that in the Romanian Agency needs and expectations of different stakeholders are identified on a continual basis through various means, both formal and informal. Thus, regular or on an ad hoc basis meetings have taken place with the industry (associations of manufacturers, the association of the companies performing clinical trials, the associations of wholesalers), with the Ministry of Health, the National Health Insurance House, the Veterinary Medicines Agency, Directorate for Investigating Organised Crime and Terrorism, the National Customs Authority), patient associations (the Coalition of Patient Organisations with Chronic Diseases, Association for Support, Advice and Protection of ADHD Children and Adolescents) and other regulatory bodies (competent authorities from other EU Member States). Feed-back from professional organisations has been received through meetings and surveys.

Surveys have also been used to assess mass-media expectations. As already mentioned in one of our previous answers, it is extremely important and downright mandatory that the Agency relationship with the mass-media be developed on a solid foundation and that taking into account the role it plays in providing public information and shaping public opinion and attitude. It is my opinion that ensuring fair bilateral relationships with the written and TV press is to the benefit of patients and the general public who, when required for reasons of medicinal product safety, have to be informed in due time and in adequate language.

Following industry representatives requests, workshops, seminars and training courses have been organised for the industry, where industry representatives had their questions answered. Agency representatives participate in a significant number of events organised by these stakeholders/interested parties. Queries are replied within maximum 30 days according to national information legislation.

Input from stakeholders meetings was considered during the ongoing relaunch of the Agency’s website.

We obviously envisage ongoing improvement of this activity of communicating with stakeholders as well.

Management of feedback from stakeholders should be more formalised in respect to collection, analysis, follow-up and communication of outcome. Questionnaires should be distributed to a broader sample of key stakeholders.

For better understanding of our policy concerning fairness to all stakeholders, I should also mention that the Agency and the Competition Council in Romania cooperate based on a protocol concluded at the end of 2009, for ensurance and promotion of competition in the field of medicinal products for human use, in line with provisions of the Law of Competition no. 21/1996, which prohibits restriction, hindrance or distortion of competition within the Romanian market.

For your information, I would like to point out that, in Romania, adoption of the Competition Law, which came into effect on 01.02.1997, represented an important step towards normalisation of behaviours in the economy by defining action rules and establishing defence methods. Through Law no. 21/1996 and secondary legislation issued in its application, Romania met its obligations as resulting from the Association Agreement between Romania and the European Union regarding competition policy, thus ensuring a high degree of compatibility in approaching and regulation of the agreements, harmonised practices, abuse of dominant position and control of economic concentrations. Competition policy legislation generally complies with provisions in Community legislation.

Extrapolating to the Romanian pharmaceutical market, the management of the two institutions has considered it fit to coordinate their respective activities for consistent application of both general legislation in the competition field and specific provisions meant for efficient operation of the market sector related to medicinal products for human use. The document in question has been set for establishment of the ways to create and maintain a balanced pharmaceutical market without prejudice to any of the participants, be they manufacturers of innovative medicines, generic medicines manufacturers, importers or distributors.

If I were to express a final message to your readers, I would like to assure them that, as a decision making factor in medicinal products for human use in Romania, the NAMMD has to and continually pursues involvement in anything regulatory in nature favouring balance of the medicinal product market, in the spirit of recommendations of the European Commission and to the benefit of the final consumer: the patient.



Company: National Agency for Medicines and Medical Devices (NAMMD) of Romania
Position: President
Country: Romania
 
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