Amendments adopted to increase availability of medicines

On 16 July 2019 Cabinet of Ministers Regulations No 899 of 31 October 2006 “Procedure for reimbursement of reimbursable medicines and medical devices” (in Latvian) was amended. The amendments (in Latvian) are claimed to be a major improvement in the availability of medicines, for example reducing patient co-payments for medicines.

Under the amendments, from 1 April 2020 a doctor, when prescribing medication from the list of reimbursable medicinal products, will state in the prescription the international non-proprietary name of the medicinal product, or the reference or cheapest equivalent-efficacy medication. In certain cases the doctor will also be entitled to indicate the name of the particular medicinal product on the patient’s medical record. Nevertheless, in any one year such prescriptions may not exceed 30% of the total prescriptions issued by the doctor.

Another provision in the regulation aims to revise the procedure for including medicines and medical devices in the reimbursement system. The provision stipulates that as of 1 April 2020, in order to be included in the compensation system, the price of medicines and medical devices must not be higher than the second lowest selling price or wholesale price of these products in the Czech Republic, Denmark, Poland, Romania, Slovakia and Hungary and will not exceed the selling price or wholesale price of the drug or medical device manufacturer in Estonia and Lithuania.

If the list of reimbursable medicinal products contains two or more equivalent therapeutic-efficacy medicinal products with the lowest reimbursement base price, the pharmacy must keep the cheapest ones in stock.

Note: according to data from the Ministry of Health, Latvian residents pay a premium of EUR 25 million for reimbursable medicines every year. The amendments aim to change this situation.

Latvia develops plan for unified and frequent action against unintended and frequent use of antibiotics

On 18 April 2019, at a meeting of State Secretaries, the Ministry of Health and Ministry of Agriculture together announced a Draft Action “Plan for the Restriction of Antimicrobial Resistance and Prudent Use of Antibiotics “One Health” 2019-2020” (in Latvian).

As noted by the Ministry of Health, in comparison to other European Union countries, the prevalence rates of antimicrobial resistance (AMR) in Latvia are among the lowest; at the same time, there is a risk that resistant micro-organisms from countries with high AMR penetration are carried into Latvia. Therefore, in order to avoid a worsening of the situation, the ministries and institutions together have created a common action plan.

For the first time, under the One Health principle a specific action plan for limiting AMR in animals has also been developed in cooperation with the Ministry of Agriculture.

The Action Plan includes specific steps in several fields of action. For example, the plan is to improve the understanding of medical practitioners, practicing veterinarians and animal owners regarding responsible and prudent use of antibiotics.

Likewise, the consequences of unjustified use of antibiotics will be explained to society, for example, by including the relevant topics in school programmes. Another plan is to monitor the use of antibiotics in Latvia more effectively.

Increased availability of medicines for patients with mental and behavioural disorders

On 23 April 2019 the Latvian government decided to expand (in Latvian) the range of diagnoses for which state-compensated drugs are provided, and to increase the amount of compensation for some existing diagnoses in the psychiatric and behavioural disorders group.

Amendments to Cabinet of Ministers Regulations No.899 of 31 October 2006 “Procedure for Compensation for Expenditure on Purchase of Medicines and Medical Devices for Outpatient Treatment” (in Latvian) provide for 100% reimbursement of medications for the following diagnoses: F71 Moderate mental retardation, F72 Severe mental retardation and F73 Deep mental retardation. So far, 100% reimbursement of medications for these diagnoses had applied only to children under 18 years of age. In addition, other reimbursements for diagnoses in the mental and behavioural disorders group are increased to 75% instead of the previous 50%.

For persons for whom outpatient treatment has been ordered by court judgment, reimbursement of medicines of at 100% will be ensured for diagnosis F07 Disorders of personality and behaviour due to brain disease, damage or dysfunction and F70 Mild mental retardation. These patients lack the will to live and so are not always ready to buy medication at their own expense. However, it is in the public interest to secure their treatment, which should therefore be ensured.

Amendments to procedures for organization and payment of health care services

On 7 May 2019 the Latvian government approved amendments (in Latvian) to Cabinet of Ministers Regulations No.555 “Procedures for organization and payment of health care services”. The goal of the amendments, which came into force on 17 May 2019, is more accessible, timely and qualitative healthcare (the text of the press release in Latvian is here).

The amendments include expanded treatment possibilities for patients with diagnosed psychiatric disorders. For example, the list of cases when patients will be able to obtain state-paid health services from an art therapist or nutritionist has been widened. The state will also pay for a psychologist’s services if provided within the framework of psychiatric treatment. Similarly, the model of healthcare services provided by a child psychiatrist and psychiatrist has been reviewed.

In the future, dental extraction under general anaesthetic in acute situations will also be paid from the state budget for patients with Disability Group I identified as a result of mental and behavioural disorders.

A number of changes apply to primary health care. For example, a new procedure has been established by which a family doctor will be able to pass their practice to a new doctor outside the waiting list by mutual agreement. As regards rehabilitation, the number of patients who will be able to receive acute and sub-acute medical rehabilitation in hospitals has been increased.

In order to attract additional professionals in certain areas of healthcare, thereby improving access to healthcare services and reducing waiting times, the payment rates for an episode of care have been increased. Additionally, new positions will be offered in several clinics.

Scheme for when information on medicinal product labels is not in the national language

The State Agency of Medicines has prepared an informative scheme of action (in Latvian) for marketing authorization holders and wholesalers for cases when medicinal products imported into Latvia do not contain information in the national language (information is available here).

Rules and regulations on procedures for labelling medicinal products and instructions for their use require medicinal products imported into Latvia to contain information on the label and in the package leaflet in the national language. However, there are exceptions, which are noted within the scheme. The scheme is only informative as compliance by each situation with legal requirements has to be assessed separately.