On 17 March 2020, a nationwide campaign was launched in Latvia in order to inform patients about the new procedure of prescribing reimbursed medicines that comes into effect on 1 April. It provides that doctors medicines reimbursed by the state will prescribe using the active ingredient of the medicine (INN), but not its brand name. Pharmacies will issue to patients the lowest-price medicine from those having the same therapeutic effect.
The procedure is recommended by the WHO and the OECD. It has been already implemented by Latvia’s neighbours, Estonia and Lithuania, as well as wealthy countries like Germany, Finland, Netherlands, Denmark, Sweden and other European states.
The new procedure is implemented for Latvia to take over the European practice of prescribing medicines, as well as to avoid the situation where patients have to buy more expensive medicines, overpaying some 25 million euros a year, although medicines with the same therapeutic effect and the same level of quality and safety are available at a lower price.
As part of campaign “KNOW and DON’T OVERPAY” (“ZINI un NEPĀRMAKSĀ” in Latvian), TV, radio, printed and online media, as well as outdoor ads all over Latvia will provide patients with useful information about the new procedure of receiving state-reimbursed medicines as of April 1. All materials of the information campaign are available to patients HERE (in Latvian and Russian).
“This transfer to the use of the medicine’s active ingredient or the international non-proprietary name in medicines' prescriptions is of national importance, as Latvia not only implements the practice which is used elsewhere in Europe, but also makes medicines much more affordable for patients, particularly for those with low income, allowing consumers to save up to 25 million euros a year,” Health Minister Ilze Viņķele emphasised the benefits of the new procedure.
It is provided that 70% of reimbursed medicines prescriptions over one-year period will include the active ingredient of the medicine, but not its brand name, and the pharmacy will issue to patients the lowest-price medicine from those having the same therapeutic effect.
Meanwhile, in almost every third prescription or in 30% of cases doctors will be allowed to use the brand name of the medicine, after giving medical reasons.
“In other countries that have implemented this procedure, the medicine’s brand name is used much more rarely than in our 70/30 model. Thus, the model implemented in Latvia ensures that both the rights of the patients and the professional activities of medical professionals are respected,” I. Viņķele emphasises.
Meanwhile, Special Representative of the WHO Regional Director for Europe Dr. Michel Thieren notes that “indicating the active ingredient in the prescription furthers the rational use of medicines and improves significantly the general quality of healthcare, as it provides patients with medicines of equivalent efficiency at a lower price. The implementation of this system is also essential for information exchange between healthcare professionals, scientists and all the countries and international organizations involved which work to improve the quality of healthcare and the availability of medicines,” Dr. Thieren emphasised.
Svens Henkuzens, director of the Latvian State Agency of Medicines: “The active ingredient is the main treating ingredient of a medicine, it is written on all medicine packs in Latin to be equally understandable to all doctors and pharmacists worldwide. Before a medicine with new active ingredients is sold, the State Agency of Medicines in one of the EU member states makes sure that the medicine helps patients and does not cause such severe side effects that do not overweigh health benefits. It also makes sure that the tablet contains the necessary active ingredients, and excipients, which create the colour and the form of the medicine and has no unnecessary ingredients. The company having registered the medicine has the exclusive right to be the only seller of this active ingredient. After 10 years, other companies have also the right to produce this active ingredient. But, prior to that, the company has to prove that the medicine will be produced with the same high quality and the active ingredient will be supplied to the human body in the same amount. Furthermore, raw materials for medicines with the same active ingredient often come from the same factory. So, we know that this active ingredient is safe and efficient already for ten years, there is no need to organize studies of its efficiency and safety involving people, which results in saving costs.
Therefore, many medicines only differ by their package, exterior, excipients, yet the active ingredient treating the patient is the same. The company which wants to register the medicine has to provide this evidence, and the agency of medicines in one of the EU countries will evaluate it. In Europe, we have not to do the same work, if a company wants to sell a medicine in several countries, it is evaluated in just one country, yet other agencies of medicines check the quality of this assessment. Already now seven of every ten sold packs contain well-known active ingredients, i.e. are so called generics.”
National Health Service Director Edgars Labsvīrs notes that prescribing active ingredients in reimbursed medicines prescriptions so far has been common practice for many doctors in Latvia: “While 2500 doctors regularly write prescriptions in the e-health system, 1808 doctors in total have prescribed the active ingredient in prescriptions in the period of January 2019 - January 2020. In January 2020 alone, about 3.5 percent of doctors indicated active ingredients in prescriptions in more than 70% cases. The e-health system is fully ready for the new procedure of prescribing active ingredients in prescriptions. We have explored how to make the prescribing active ingredients more convenient and faster, because for doctors now this is slightly more time-consuming process than in case of prescribing an brand name. Yet, once you have prescribed the active ingredient for the first time, the system saves the template and you have not to rewrite it.”
A majority of patients who used the lowest-price reference medicines from the list of reimbursed medicines, will be able to keep on using their usual medicines, because, according to data of the National Health Service, reference medicines have not changed in 85% of cases.
When it became known that the new procedure will take effect on April 1, manufacturers have cut prices for 250 reimbursed medicines, including 50 lowest-price medicines.
To make the transfer to the new procedure of prescribing medicines reimbursed by the state easier, the Ministry of Health, the State Agency of Medicines, the National Health Centre and the Health Inspectorate have been informing doctors and pharmacists about the new procedure since November last year.
“So far significant work has been done to inform doctors and pharmacists. Videos explaining the prescription of active ingredients in the e-health system, both printed and digital leaflets have been prepared and circulated, we also participated in conferences and seminars for doctors and pharmacists and explained the new procedure to them, and published information in specialised media for doctors and pharmacists and distributed handouts for patients. On March 16, we will launch a nationwide campaign “KNOW and DON”T OVERPAY” to inform the public, which will last until the beginning of April,” Minister of Health I. Viņķele told about informing pharmacists and doctors.
- The active ingredient is the main treating substance of a medicine. The excipients create the form, colour, taste and other qualities of medicines.
- Medicines with the same active ingredient and the same effect may have different manufacturers, names, appearances (colour, form and packaging) and also prices.
- For patients to pay less, as of April 1 doctors will indicate in the prescription of reimbursed medications only the active ingredient.
- The state pays for (reimburses) the medicines with the lowest price from medicines with the same active ingredient and therapeutic effect.
- If there are medical indications, the doctor will write in the reimbursed medicines prescription a medication with the same active ingredient that has a higher price and the same therapeutic effect, and the state will compensate it.
- The doctor and the patient agree on whether the patient will use the medication reimbursed by the state. In this case, the doctor will prescribe reimbursed medicines.
- Please take into account that from April 1 patients in pharmacies will no longer be able to pay for more expensive medications reimbursed by the state.
- The active ingredient of the medicine, i.e. the international non-proprietary name, is indicated on the medicines packing with smaller letters and often in italics, and can be also found in leaflets of all medicines. This name appears on the packing next to the manufacturer’s brand name, which is written in capital letters.
- Useful information about the new procedure and materials of campaign “KNOW and DON’T OVERPAY” are published on www.esparveselibu.lv - HERE (in Latvian).
What patients should take into account?
There will be no major changes or inconveniences for consumers after the new procedure of prescribing medicines reimbursed by the state takes effect on April 1. Although there may be situations when a pharmacist issues a medicines whose packing, colour or form may differ from the usual one, this medicines will have the same effect, quality and safety.
To avoid unnecessary concerns, the Latvian Ministry of Health and the State Agency of Medicines encourage people who need medicines reimbursed by the state to visit their doctor in time.
Amendments to Cabinet Regulation No. 899 of October 31, 2006 “The procedure for compensating expenses for the purchase of medications and medical devices intended for out-patient treatment” will take effect on April 1, 2020.